Tuesday, March 9, 2010
Continuous Left Atrial Pressure Monitoring Helps With Management, Outcomes in CHF Patients
St. Jude Medical is touting results of a recently published study that analyzed the clinical benefits of frequent and regular left atrial pressure (LAP) monitoring in patients with heart failure. In the study, patients wore a special device, called HeartPOD, that monitored their LAP and routed the data wirelessly to their cardiologist. The physician, in turn, was able to adjust the prescription drug dosage taken by the patient on a daily basis. The results show that this leads to better overall outcomes for patients and a greater understanding of the condition for the physicians involved.
The above picture was given to us by St. Jude Medical. And we think it has a clue as to the future of this technology. Imagine this kind of monitoring shows more and more positive outcomes in the future clinical studies, and it wins all needed regulatory approvals. One day we might be seeing these pressure monitoring sensors embedded into the electrodes of AICDs and pacemakers. Wouldn't that be neat?
Results from this study demonstrated that regular monitoring of LAP in combination with a dynamically adjusted prescription plan can be used to drive appropriate adjustment of HF treatments, and as a result, improved LAP control and reduction of HF events that may result in hospitalization or death.Following implantation of an LAP sensor, all subjects in the study were free of major adverse cardiac and neurological events at six weeks, meeting the trial's primary endpoint. Over a median follow-up of 25 months, LAP control was achieved for at least six consecutive months in 76 percent of patients, with a 67 percent reduction in the frequency of elevated LAP readings (over 25 mmHg). Throughout this same period, there was a significant 84 percent average decrease in HF events including HF hospitalization and all-cause mortality once LAP-guided therapy was initiated. Over the course of treatment, patients also had significant improvements in HF symptoms and quality of life.
The report outlined results of the first 40 patients enrolled in the trial; 20 patients enrolled in three Australian or New Zealand sites and 20 patients enrolled in four U.S. sites.
The early results of the HOMEOSTASIS trial led to the establishment of the LAPTOP-HF (Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy) Study, a larger pivotal, randomized, controlled, prospective, multi-center clinical investigation. The LAPTOP-HF study will be conducted under a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) and is expected to begin in the first half of 2010.
Abstract in Circulation: Physician-Directed Patient Self-Management of Left Atrial Pressure in Advanced Chronic Heart Failure
Press release: St. Jude Medical Announces Publication of Feasibility Results for Trial of Novel Heart Failure Management System ...
Medgadget 2005 flashback: HeartPOD...
(0)
Tuesday, March 9, 2010
VERATHERM Hyperthermic Perfusion System Gets FDA Green Light
ThermalTherapeuticSystems of Pittsburgh, Pennsylvania received FDA regulatory approval to market the VERATHERM Portable Hyperthermic Perfusion System in the US. The portable device provides cardiac perfusionists with the ability to regulate and monitor the temperature, pressure and flow of sterile fluids, such as cardioplegia.
Features from the product page:
Overall Console Dimensions: 12" x 19" x 14.7" [HxWxD] Weight: 26.4 pounds Computer: Touch screen controls, stores and manages procedure data Propulsion: 250-4000mL/min flow range Temperature Source: Direct thermoelectric Temperature Set-point: Warms fluid to maximum settable 43°C regardless of liquid or base temperature Temperature Monitoring: Built-in direct temperature monitoring In-line Pressure Monitoring: Built-in direct pressure monitoring Disposable: Proprietary design with integrated temperature and pressure sensors efficiently delivers sterile fluids Features: Disposable pressure and temperature sensors are built into the device; telescoping IV pole (37.5" extended height) Use and Location: Portable and fully functional wherever 115 VAC, 50/60Hz, 15 Amp power is available Storage: Shelf, storage closet or table-top Disinfection: Fluid is contained within the disposable set, so that there is no direct console contact with any fluid. This allows for quick and easy disinfection of the console.
Press release: ThermalTherapeutic Systems Announces FDA Clearance of the VERATHERM(TM) Portable Hyperthermic Perfusion System ...
Product page: VERATHERM Portable Hyperthermic Perfusion System ...
(hat tip: MassDevice)
(0)
Friday, March 5, 2010
Syncardia's Freedom Mobile Artificial Heart Driver Gets CE Mark
SynCardia of Tucson, AZ, maker of the CardioWest Total Artificial Heart, has received European approval for the Freedom wearable driver. The device allows patients to get off the "Big Blue" driver that powers their heart in the hospital after implantation, and regain a sense of mobility while on wait for a permanent donated organ. It's not clear how long the batteries last before requiring a recharge.
From the announcement:
SynCardia hospital drivers support patients from Total Artificial Heart implant until their condition stabilizes. Once stable, European patients will be switched to the Freedom driver and discharged from the hospital to wait for their matching donor heart at home.The Freedom driver weighs 13.5 lbs including two onboard lithium ion batteries and a power adaptor. It can be conveniently carried by the patient in the Freedom Backpack or Shoulder Bag. The Freedom driver is 60% lighter than SynCardia’s older CE approved “proof of concept” portable driver, which weighs approximately 35 lbs and is transported in a wheeled caddy.
The Freedom driver uses a “dark cockpit” design philosophy for simple and easy operation. Similar to an airplane cockpit, the system only flashes a light or sounds an alarm when something requires the user’s attention.
To make maintenance easier for hospitals, the Freedom driver is serviced by replacement via express delivery. No onsite repair or inventory of parts is required by the hospital.
Press release: Freedom Driver System Receives CE Mark to Power SynCardia's Total Artificial Heart in Europe ...
Flashbacks: Medgadget's SynCardia archives...
Images courtesy of syncardia.com.
(0)
marLED Surgical Lights from KLS Martin
By perusing through the latest stuff coming out of Germany, we found a little press release from Gebrüder Martin GmbH & Co.KG, also known as KLS Martin Group, that profiled the company's new generation of operating lights, named marLED.
This operating room fixture runs on what the company calls "Second-Generation LEDs" and is designed to minimize formation of shadows and to deliver a cold, bright light. Furthermore, the marLED can be equipped with KLS Martin's surgiCam SD and HD camera systems, for an intraop procedure recording. The camera can be seen in the picture below.
From marLED product page:
In this brand-new product line, high-performance LEDs are used as a basis for effective problem solution even where surgical field illumination is difficult. By using a new overall approach in terms of design as well as lighting technology, it was possible to overcome the limits of existing solutions and set new standards regarding shadow prevention and color fidelity. The radically new optical and housing concept also makes a lasting contribution towards facilitating the surgeon's work. The innovative, modern design with its symbiosis of ergonomics and technology gives the operating room a pleasing, state-of-the-art atmosphere.Maximum adaptation of the light field Space-saving design creates room for movement Compatibility with laminar flow systems Ergonomic and perfectly easy operation with sensoTouch and sensoGrip Cool light and excellent shadow compensation Variable color temperature
Product pages: marLED; surgiCam
Press release: The marLED Lights from KLS Martin ...
(0)
Wednesday, March 3, 2010
SJM's Aortic Trifecta Valve Gets European Clearance
St. Jude Medical's new pericardial aortic stented tissue valve, the Trifecta, has been granted CE Mark of approval by the European authorities.
Some details about the implant:
The next-generation tissue valve has a tri-leaflet stented pericardial design which offers excellent hemodynamic performance, or nearly unobstructed blood flow, in order to mimic as closely as possible the flow of a natural, healthy heart. The unique valve design includes leaflets manufactured from pericardial tissue attached to the exterior of the valve stent which open more fully and efficiently to perform like a natural heart valve.The valve's titanium stent, which provides a fatigue resistant frame to support the valve within a patient's heart, is covered with pericardial tissue to allow tissue-to-tissue contact when the leaflets open and close, which reduces the amount of wear and deterioration. Additional attributes contributing to the Trifecta valve's durability include proprietary tissue fixation and St. Jude Medical's patented Linx(TM) AC Technology, an anticalcification treatment designed to reduce tissue mineralization (hardening).
"The Trifecta valve's superior hemodynamic performance helps to make it very attractive for aortic valve replacement, especially in a small aortic annulus," said Professor Volkmar Falk, Chair of the Division of Cardiac and Vascular Surgery at University Hospital Zurich. "The construction and design of the Trifecta valve allows it to work seamlessly with the patient's heart to generate adequate blood flow, which can offer patients an improved quality of life."
Press release: St. Jude Medical Receives CE Mark Approval for Trifecta Valve ...
(0)
Friday, February 26, 2010
RoSS Simulator Preps Surgeons to Use da Vinci Robot
Researchers from Roswell Park Cancer Institute and State University of New York at Buffalo, developed a surgical simulator to help train physicians to operate the da Vinci robot. The RoSS Robotic Surgical Simulator has been turned into a product and commercialized by a spinoff called Simulated Surgical Systems of Williamsville, NY. Practicing physicians and students can train on common tasks like suturing and knot tying, and even perform complete procedures like radical prostatectomies and hysterectomies.
Features of the device:
Stand-alone surgical simulator that is independent of a surgical robot, vision cart Cost of operating the RoSS is minimal as no consumables or disposables are required The RoSS data management system allows performance analysis and measurement tools to objectively measure and record performance User does not require monitoring thus enabling maximum flexibility and opportunity for training Surgical procedures can be rehearsed New surgical procedure modules can be added to the RoSS RoSS does not require an operating room environment and can be set up in a location most advantageous to access and training needs RoSS has a monitor which allows a user or tutor to observe the procedure Comprehensive curriculum to train for motor, and cognitive skills required to operate surgical robot Suite of simulated surgical procedures for fellow or resident to follow, and recreate the surgical steps of an expert surgeon
Press release: Introducing RoSS, a "Flight Simulator" for Robotic Surgery ...
Product page: RoSS Robotic Surgical Simulator ...
(0)
Thursday, February 25, 2010
Sorin's C5 CPB Machine Gets Green Light in US
Milan, Italy based Sorin Group has received FDA approval for the firm's S5 Heart-Lung Machine. In its press release, the company touts C5 as a highly advanced "lighter in weight and more compact" system that has "excellent manoeuvrability and a well thought-out, logical structure, functional ergonomic design and reliable safety systems. Its solid, brushed stainless steel housing reflects the product's high quality." The cardio-pulmonary bypass (CPB) system has already earned European CE Mark of approval last year.
Add'l features:
Console for 3 to 5 roller pumps 2 additional roller pumps can be mounted on the mast Panel with 3, 4 or 6 display modules Flexible mast system Pump heads can be rotated into position to optimize tubing layout Two vertically and one horizontally moveable masts for mounting external devices and disposables Up to four TFT displays can be stacked vertically in the mast panel and each can be configured according to your required perfusion parameters The brushless, direct-drive motor of the roller pumps reduces noise and vibration, making S5 one of the quietest systems of its kind The footprint of the S5 has been reduced by 20% and overall weight has been reduced by 10% System panel can be easily mounted and adjusted both horizontally and vertically High resolution TFT displays enable the perfusionist to easily view displayed values from greater distances and at an angle of up to 140 degrees Full text messages for alarms and warnings One key each for muting, clearing and overriding alarms Differentiated alarm tones Quick and easy replacement of all DCMs UPS can bridge a power failure up to 130 minutes (20 minutes at full load) Speed adjustments are performed via an Incremental Encoder, a maintenance-free technology that increases longevity and reliability Clearly structured, intuitive and descriptive menu system eliminates guesswork, and one-touch accessibility improves user convenience Miniaturized sensor modules utilize 100% SMD technology Operated by PC-independent software using state-of-the-art microcontrollers in conjunction with a high-integrity serial CAN bus No boot time required after power-up—the system is ready for operation within 3 seconds
Product page: S5 HLM...
Press release: SORIN GROUP ANNOUNCES U.S. FDA CLEARANCE OF NEWEST GENERATION HEART LUNG-MACHINE (.pdf)...
(0)
Tuesday, February 16, 2010
GE's Vscan, World's Smallest Portable Ultrasound, Now Available Worldwide
GE Healthcare is finally releasing the much awaited Vscan pocket sized ultrasound. Many in the industry hope that this device offers a chance for physicians to make a move from stethoscopes to portable imaging devices, bringing advanced visualization to any examination room. The unit weighs one pound and is only 3 inches (7.6 cm) wide and 5.3 inches (13.5 cm) long, offering both standard black and white imaging, as well as colored blood flow doppler. GE is touting Vscan's size and capabilities for cardiologists to transthoracically view myocardium, pericardium, and heart valves, and for primary care physicians, as well as OB, ER, and others, to scan the liver, kidney, 
aorta and peripheral vessels, babies in the womb, and anything else the transducer can penetrate.
Features from the product FAQ:
An online portal provides Vscan users with training tools for the product and basic clinical
applications with sections about imaging technique, anatomy and trouble shooting
Intuitive user interface that can be controlled using the thumb
Intelligent workflow enhancements
Battery charger station and battery life of one hour scanning - good for up to 30 patients based on
average of 2 minutes per scan
Voice annotation
USB docking station
Link to a PC for organization and export of data
Gateway software with services tools and remote diagnostics
Here's our video from a GE event introducing the Vscan:
Press release: GE Healthcare Introduces Vscan™ Pocket-sized Visualization Tool for Point-of-care Imaging
Product page: Vscan ...
Flashbacks: A Closer Look at GE's Vscan Pocket Ultrasound ; More Details About The New GE Vscan Ultrasound System; GE's New Ultra Small Ultrasound May Become as Ubiquitous as Stethoscope
(4)
Thursday, February 11, 2010
FDA Approves World's Most Powerful Cardiac Resynchronization Therapy Defibrillator
Sorin Group (Milan, Italy) has announced U.S. FDA approval and first implant of its next-generation of cardiac resynchronization therapy defibrillator (CRT-D), Paradym CRT Model 8750. According to the company, this is the world's most powerful AICD, with a 37 Joule punch:
Paradym™ offers consistent charge times throughout the life of the device (10s at Beginning Of Life, 13s at Elective Replacement Indicator - ERI), improved longevity, and a 6-month ERI to End of Service (EOS) period, twice as long as any other ICD.Paradym™ CRT is designed to allow more flexibility in the management of cardiac resynchronization and antitachyarrhythmia therapy in heart failure patients. BTO (Brady-Tachy Overlap) is designed to unlock pacing and detection to ensure delivery of resynchronization therapy at high pacing rates during exercise without any compromise on the management of slow ventricular tachycardias (VTs). BTO gives freedom of programming for physicians.
Paradym™ CRT, at 34cc and 11mm thin, also features the PARAD®+ detection algorithm whose superior specificity in discriminating ventricular arrhythmias has been clinically proven. Studies have demonstrated that the absolute risk of experiencing an inappropriate shock has been observed to be only 5%, the lowest percentage recorded thus far.
Press release: SORIN GROUP ANNOUNCES MARKET RELEASE AND FIRST IMPLANT OF NEXTGENERATION CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR...
Product page: PARADYMTM CRT 8750 ...
(0)
Friday, February 5, 2010
St. Jude Medical Gets Go Ahead for New Implantable Cardiac Devices
St. Jude Medical has received the European CE Mark of approval for the Fortify and Fortify ST implantable cardioverter defibrillators (ICD) and Unify cardiac resynchronization therapy defibrillator. The devices are smaller and can deliver a stronger punch than previous generation models, and they feature new heart monitoring algorithms.
These devices feature 40J of delivered energy (45J stored) - the highest energy level available in the industry - helping to ensure that therapy will be successful for those patients who require a higher energy shock for defibrillation.Because of the devices' narrower shape, physicians can implant them using a shorter incision, leading to less time spent closing the incision and a smaller scar for the patient. The company's SJ4 lead connector system further streamlines the procedure by reducing the number of connections between the defibrillation lead and the device, which can improve patient comfort by reducing the bulk of wires in the patient's chest.
The Unify CRT-D and Fortify ICD also incorporate the new CorVue(TM) pulmonary congestion monitoring algorithm. This new feature alerts physicians when a patient's heart failure may be worsening, as evidenced by changes in electrical signals that can be correlated to increased congestion, or fluid retention, in the chest area. The algorithm continuously monitors fluid retention in multiple vectors, providing an accurate diagnostic and an alert designed to minimize false positives.
Both devices also have features that are designed to assist in the reduction of unnecessary shocks, including painless anti-tachycardia pacing, which can be used for fast ventricular arrhythmias prior to or while the device is preparing to deliver shock therapy, and other enhanced technology for reducing inappropriate therapy.
In addition to the family-wide features of the Unify and Fortify devices, the Fortify ST ICD features St. Jude Medical's first-to-market ST segment monitoring diagnostic algorithm, which can add important information to assist in medical decision making and accelerate patient care. The Fortify ST ICD continuously monitors for specific changes in the ST segment of the electrocardiogram that can indicate the onset of serious conditions such as ischemia.
Press release: St. Jude Medical Announces European Approval of Smaller, Higher Power ICD and CRT-D Devices with New Heart Failure Monitors
(1)
Wednesday, February 3, 2010
Duo Ablation Catheter Going on Trial
The FDA has cleared St. Jude Medical to initiate a clinical trial of the company's Duo irrigated ablation catheter for treatment of atrial fibrillation. The device, which already has the European CE mark, features twelve irrigation ports that should provide better cooling of the electrode during ablation.
The IRASE AF trial is the industry's first and the largest head-to-head IDE trial studying irrigated ablation catheters, which use radiofrequency (RF) energy in a non-invasive procedure to destroy abnormal heart tissue. The trial will randomize patients 1:1 between the company's Duo 12 port open irrigated catheter ablation system and an irrigated catheter ablation system that has been approved by the FDA for the treatment of paroxysmal AF, a type of AF that begins suddenly and ends spontaneously. The trial is expected to take about three years to complete and will take place in both the U.S. and international markets with 324 patients.When the first line of therapy for the treatment of paroxysmal AF using antiarrhythmic medication is ineffective, RF ablation is currently recommended as a second line of therapy for long-term cardiac arrhythmia control. The IRASE AF pivotal study intends to determine whether or not ablation using the company's Duo 12 port open irrigated catheter system is safe and effective compared to the other market approved catheter for treatment of symptomatic paroxysmal AF. It will also determine if the ablation catheter can be indicated for the treatment of symptomatic paroxysmal AF.
The trial's primary efficacy endpoints are targeted pulmonary vein isolation (acute) and freedom from symptomatic AF for 12 months (chronic) following the procedure. The primary safety endpoints are freedom from acute major adverse events within seven days of the procedure and chronic major adverse events within 12 months.
Press release: St. Jude Medical Announces IRASE AF Clinical Trial to Evaluate Cardiac Ablation Catheter System for Treatment of Atrial Fibrillation...
Product page: Therapy Cool Path Duo...
(0)
Tuesday, January 26, 2010
Melody Transcatheter Artificial Valve Finally Gets Go Ahead in US
The FDA is making Medtronic very proud by awarding the company the first US regulatory approval for a transcatheter cardiac valve replacement. The Melody system is designed to be an alternative option to open heart surgery, and it will now be indicated for peds and adults with congenital heart disease who have dysfunctional right ventricular outflow tract conduits. The Melody Transcatheter Pulmonary Valve and Ensemble Delivery System have received European approval back in 2006. We've been covering this system for the last four years and we are honestly happy to see it's finally making the debut to the cardiac market.
From a statement by the FDA:
Clinical studies of 99 participants in the United States and 68 participants in Europe showed that the device improved function of the heart, and the majority of participants have noted improvements in their clinical symptoms. The device showed similar, limited durability compared with existing alternative treatments; 21 percent of U.S. participants experienced a stent fracture, a rate consistent with stent fractures reported for the bare metal stents presently used to treat congenital heart defects of the pulmonary valve.As a condition of the FDA’s approval, the system’s manufacturer, Medtronic Inc. of Minneapolis, will conduct two post-approval studies to assess long-term risks and benefits as well as to evaluate the physician specialization needed to perform the implantation procedure, also called generalizability. One study will continue to follow 150 participants from the initial clinical trial for five years, and the second study will enroll more than 100 new participants to be evaluated over five years, in order to evaluate and assess the training program. Safety and benefit assessments will be part of both studies. The FDA also requires that Medtronic maintain a database of Melody recipients.
Here's a video of an implanted Melody valve in action:
Press releases: FDA Approves First Percutaneous Heart Valve...; Medtronic Receives FDA Approval for First Replacement Heart Valve Implanted Without Surgery...
Flashbacks: Melody Transcatheter Cardiac Valve Replacement Shows Good Results in Children; Medtronic's Melody Transcatheter Pulmonary Valve on Track for Approval; Melody Transcatheter Pulmonary Valve Still Being Tested in the US; The Melody Transcatheter Pulmonary Valve
(0)
Thursday, January 21, 2010
HeartMate II LVAD as Permanent Option for Heart Failure
The FDA has just issued clearance for Thoratec Corporation's HeartMate II LVAD (left ventricular assist device) to be used as a permanent therapy in patients with severe heart failure that are not candidates for organ replacement. The system has garnered FDA's approval in April of 2008 as a bridge to transplantation, a typical indication for LVADs. By issuing this latest verdict, the first its kind, FDA is now taking the LVAD industry (and cardiac surgery) to a completely new, larger, and potentially more lucrative market.
From a statement by the FDA:
HeartMate II consists of a small, lightweight blood pump implanted in a patient's chest just below the heart. An electrical cable that powers the blood pump passes through the patient's skin to an external controller worn around the patient's waist.A physician designates the pump's speed based upon clinical need. The device is designed to sound an alarm upon malfunction or other potentially drastic changes that could impact the pump's operation.
"The approval of HeartMate II provides an option for heart failure patients who cannot receive a transplant," said Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health. "Its smaller size and mobility should allow more patients, including women and men of smaller stature, access to treatment."
In a randomized clinical study of 200 participants at 38 centers, 46 percent of 134 participants with the HeartMate II were still living after two years with no disabling stroke or need for a reoperation for device replacement or repair compared with 11 percent of 66 participants in the control group. In addition, data collected in a separate registry of smaller stature women and men indicated that the device worked well in this specific population.
As a condition of the FDA's approval, the company will conduct a post-approval study to further evaluate the device's performance.
FDA press release: FDA Approves Left Ventricular Assist System for Severe Heart Failure Patients...
Product page: HeartMate II...
Flashbacks: FDA Approves Thoratec Heart Pump; HeartMate II Shown Effective In Waiting Transplant Candidates; Canadian Receives HeartMate II Non-Pulsatile LVAD, Eh?; HeartMate® II Left Ventricular Assist System
(hat tip: MassDevice)
(0)
Tuesday, January 19, 2010
IMRIS Combination MRI Fluoroscopy Systems for Intraprocedural Multimodal Imaging
IMRIS out of Winnipeg, Canada recently received FDA approval to market the firm's neurovascular and cardiovascular combination MRI/X-ray angiography systems. The IMRISnv and IMRIScardio systems feature MRI scanners that ride on rails attached to the ceiling and a complete fluoroscopy package that can be swung in and out of the surgical field. This combination allows clinicians to quickly evaluate the problem, perform a procedure, and then check back with the MRI to see how it went, all without moving the patient.
IMRISNV features a wide bore 3T MRI scanner and a bi-plane angiography system completely integrated into a single suite that permits the patient to transition quickly and seamlessly between MR imaging and intervention without transporting the patient between modalities. Using IMRISNV, MR images can be taken before and during procedures to assess tissue health, and can also be used in conjunction with the fluoroscopic images during the interventional procedure. On completion of the procedure, new images can be taken to evaluate the intervention.IMRIScardio provides physicians with enhanced images for visualizing the cardiovascular system before, during and after an intervention. The IMRIScardio suite includes a wide bore 1.5T MRI scanner and a single-plane or biplane angiography system providing the ability to alternate between imaging modalities and immediately assess treatment.
Link: IMRIS...
Press release: IMRIS RECEIVES FDA CLEARANCE FOR IMRISNV AND IMRIScardio... (.pdf)
(0)
Friday, January 15, 2010
Transcatheter Mitral Valve Implantation Technology from CardiAQ
Transcatheter aortic and pulmonic valve replacements are shaping up to become attractive alternatives to open heart surgery, as we have seen with products such as Melody Pulmonary Valve and Edwards Sapien Aortic Valve. But the same cannot be said of mitral replacements.
The mitral valve has a complicated anatomy, as well as a precarious intracardiac left AV position that's difficult to access. Then there is also the issue of a complex etiology of mitral regurgitation, such as ring dilation, chordae rupture, or cusp damage. So the transcatheter MVR development has seen its share of failures and difficulties. Now CardiAQ of Winchester, Massachusetts thinks that it has developed a novel percutaneous solution for mitral regurgitation patients that doesn't use a radial force to attach the artificial valve, overcoming the main problem of performing mitral valve replacement. To help move the company's Transcatheter Mitral Valve Implantation (TMVI) forward, the firm just finished a $6.5 million 'Series A' fund raiser, giving us hope that we might be seeing this technology in cath labs within a short period of time.
1. INSERTION. A catheter carrying the replacement valve is threaded through the femoral vein and up into the right atrium of the heart. It is passed through the intra-atrial septum, into the left atrium, and down through the mitral annulus.2. POSITIONING. The valve is partially expanded to engage the ventricular side of the annulus and establish the proper position. While the valve is now functional, it can be recaptured and adjusted prior to final deployment, if necessary.
3. ANCHORING. With the valve in position, the sheath is retracted fully. Foreshortening of the frame creates a clamping action that anchors the valve above and below the annulus.
Company page: CardiAQ...
More from MassDevice...
(1)
Wednesday, January 13, 2010
IntroSpicio 1.2 mm Disposable CMOS Camera for Cardiovascular Angioscopy
Earlier this week we mentioned the Video Scout, what we thought was a small video camera, at only 3mm in diameter. Now we learn of a product from Medigus of Omer, Israel that is less than half the size of the Video Scout. The IntroSpicio 120 CMOS camera has a 1.2mm diameter, but unlike the Video Scout requires external illumination to guide its path. Israel's business newspaper Globes is now reporting that Voyage Medical out of Redwood City, CA (we can't find website link) has purchased $6.5 million worth of these cameras to implement in the firm's upcoming cardiovascular angioscopes.
From Globes [online]:
The camera employs a CMOS sensor developed by TowerJazz Ltd., and which is manufactured at the company's Fab2 in Midgal Ha'Emek using Tower's 0.18-micron CMOS image sensor process.Medigus said that, in a global first, its camera will make it possible to insert a camera directly into the heart through the blood vessels, enabling Voyage Medical's proprietary endoscope to image heart tissue in real time and while performing procedures.
Specifications from the IntroSpicio 120 brochure:
System Components: 1.2mm (outer-diameter) camera, head with optics plus video, processor unit
Image pick-up device: CMOS
Effective pixels: 49,280
Resolution: 220H x 224V
Video outputs: NTSC, VGA
System Functions: Gain, White Balance, Automatic Gain, Control, Red/Blue Enhancement, Brightness, Zoom, Freeze, Print, Save – 4 images, (additional memory – optional).
Power Supply: AC100-240V 50/60Hz
Field of View: 100°
Dimensions: <Camera head> Shape: circular, Outer-diameter: 1.2mm, Length: 5mm
<Camera cable> Length: up to 3 meters
<Video processor box> 300mm(W)x70m(H)x250mm(D)
More from Globes [online]...
Product page: IntroSpicio 120...
IntroSpicio 120 brochure... (.pdf)
(0)
Wednesday, January 6, 2010
Will PHOENIX Combination Delivery System Be TMR of the Future?
Cardiogenesis out of Irvine, CA is reporting that it has submitted an IDE (Investigational Device Exemption) to the FDA "to initiate a safety and feasibility trial for its PHOENIX System in patients with refractory angina." The PHOENIX Revascularization Delivery System is a combination device designed to perform two primary functions:
1. Being equipped with holmium:YAG laser, the system can perform Transmyocardial Revascularization (TMR) during open heart surgeries, a common procedure usually used for end-stage coronary artery disease. During TMR the surgeon makes transmyocardial holes with a laser, and that is thought to be responsible for induction of angiogenesis in myocardium.
2. PHOENIX handpiece is specifically designed to let cardiac surgeons inject "biologic or pharmacologic agents to pre-determined areas of myocardium" during TMR. The hope is that in the future this technology will allow us to provoke a more robust angiogenesis, or maybe, depending on the agent, allow the delivery of positive inotropes to compromised areas of myocardium.
In its press release, Cardiogenesis states that some clinicians in Europe are already experimentally using the PHOENIX System in concert with bone marrow derived stem cells, and that "the addition of stem cells is synergistic and this combination therapy offers the potential to improve clinical results."
More about the device:
The PHOENIX includes an integral CrystalFlex fiberoptic component consisting of thirty-seven 100 µm diameter fibers, identical to the fiberoptic component currently in use in the FDA approved Sologrip® III and PEARL(TM) 5.0 handpieces. The handpiece has been modified to include three 26 gauge needles positioned around the fiberoptic fibers, which allow precise delivery of biologic/pharmacologic fluids into the tissue surrounding the channels created by the fiberoptic.
The PHOENIX System utilizes the Ho:YAG thermoacoustic stimulated tissue zone and introduces additional potent, therapeutic agents into the targeted myocardium to dramatically enhance the healing process.Improved long-term survival
Reduced cardiac-related hospitalizations
Enduring long-term angina relief (beyond 5 years)
Reduction in anti-anginal and cardiac medications
Improved quality of life
Robotic and thoracoscopic treatment options (PEARLTM) Advances the application of therapeutic biologics in treating heart disease
Convenient combination delivery tool designed for one-handed operation
Precisely and accurately delivers measured biologic to the thermoacoustic stimulated tissue zone
Press release: Cardiogenesis Submits IDE to Initiate a Clinical Trial for Its PHOENIX Combination Delivery System...
(0)
Monday, December 21, 2009
Sutureless ATS 3f Aortic Valve Gets EU Green Light
ATS Medical of Minneapolis, Minnesota has announced winning the CE Mark from the European Union to market its ATS 3f replacement aortic valve. In an attempt at aortic bioprosthesis humor, the company calls it the "original you tube" claiming it functions more like a natural valve compared to competing products.
Features from the product page:
By using a single suture line at the annulus and tacking the commissural tabs to the sinotubular junction (STJ), the continuity between the annulus and the STJ is restored with implantation of the ATS 3f Aortic Bioprosthesis. Maintaining the continuity between the annulus and the STJ, without a second suture line at the sinuses, preserves sinus form and function. Sinuses facilitate better vortex formation early in systole and smooth closure of the aortic vale, thereby avoiding the buildup of abnormal stress in the leaflet. Turbulent flow and greater leaflet stress is a consequence of sinus loss. Loss of sinuses results in leaflet and aortic wall contact, greater regurgitation during a longer systole and abnormal leaflet bending during closure. Because it is tubular, the ATS 3f Aortic Bioprosthesis restores physiologic, non-turbulent trans-prosthetic flow that is indistinguishable from flow across a native aortic valve. The ATS 3f Aortic Bioprosthesis is a stentless pericardial valve that replaces the diseased native aortic leaflets. Since there is no bulky stent, minimal tissue is implanted achieving essentially a 1:1 annulus to orifice ratio and laminar flow, just like a native valve. Because it is tubular, the ATS 3f Aortic Bioprosthesis restores native valve stress distribution to the entire aortic root. The form and function of a native valve is reproduced with the implantation of the ATS 3f Aortic Bioprosthesis resulting in minimal stress at the commissures, just like a native valve.
Press release: Enable is the First and Only Commercially Available Sutureless Surgical Tissue Valve...
Product page: ATS 3f Aortic Bioprosthesis...
Company video describing the product below the fold:
(0)
Friday, December 18, 2009
Cardiopulmonary Bypass Pump Brings Attractive Aesthetics to Grim Situations
In October, LIFEBRIDGE Medizintechnik of Ampfing, Germany won FDA approval for the B2T heart-lung machine. The portable unit is designed to be percutaneously (fem-fem) connected to the patient for quick circulatory support during acute cardiac failure. Last year this system won a red dot product design award.
The unique level of automation allows the system to be ready for use within 5 - 10 minutes and guides the trained user intuitively through the menu on the integrated display in five steps. The Lifebridge reaches a blood flow of up to 6 l/min and is powered by a mains voltage of 110/220V AC. For mobile operation, the system can be switched to battery power for a period of up to 2.5 hours. It contains an automatic seven stage air safety system preventing air embolisms.
Some technical specs:
Blood flow: Up to 6 liters/minute (active drainage, depending on cannulation) Gastransfer: Adult according A.A.M.I Set-up time: Only a few minutes through semi-automatic priming and de-bubbling Max. Support time: 6h Air emboli protection: 7-fold air elimination system Display: Touch screen to guide the user and to monitor the system status Power supply (mains): 110/230 Volt AC or 24 Volt DC Power supply (battery): 2 hours + 30 minutes Weight: 17,5 kg (38 lb) without base station Dimensions: 24 inch x 17 inch x 14 inch (W/H/D) without base station
More from MTB Europe...
Product page: The LIFEBRIDGE B2T...
Press release: Novel Cardio-Pulmonary Support Device LIFEBRIDGE from Germany gains FDA Clearance... (.doc)
red dot design award announcement...
(0)
» TAArget Thoracic Stent Graft Going on Trial (December 10, 2009)
» 3D Recon Turns CT Axial Images into Volumetric Visualizations (November 25, 2009)
» Let Draeger Polaris Be Your Guiding Light (November 20, 2009)
» HeartWare Heart Pump Shows Positive Results in Clinical Study (November 16, 2009)
» FDA Grants Vascular Solutions Clearance for The GuideLine Catheter (November 12, 2009)
» A New LED Powered Endoscope from Schölly (November 10, 2009)
» Melody Transcatheter Cardiac Valve Replacement Shows Good Results in Children (November 10, 2009)
» TRUMF's OR Table Integrated With Siemens Multi-axis Fluoroscopy Systems (October 26, 2009)
» ThumBlade Scalpel Safety System (October 21, 2009)
» Mobile Driver for CardioWest Artificial Heart Gets EU OK (October 19, 2009)
» Abiomed Reports New Positive Impella 2.5 Results (September 24, 2009)
» New Surgical Glue from Lifebond to Offer a Stronger, Tighter Seal (September 21, 2009)
» Sensei X Robotic Catheter System for Electrophysiology Procedures (September 18, 2009)
» Under Development: Pneumatic Heart Pump for Minimally Invasive Delivery (September 14, 2009)
» MAQUET Releases VASOVISION Heads-Up Display for Vessel Harvesting for CABGs (August 20, 2009)
» HeartAssist 5, The Latest DeBakey LVAD, Keeping First Patient Alive (August 19, 2009)
» Surgem Interactive Surgical Planning Environment for Pedi Hearts (August 11, 2009)
» Endoscopic Vein-Graft Harvesting Fight Heats Up (July 28, 2009)
» Cook's TX2 Pro-Form Thoracic Endograft Gets US Green Light (July 28, 2009)
» Medtronic's Melody Transcatheter Pulmonary Valve on Track for Approval (July 27, 2009)
» VasoNova Gets to The Heart of The Matter (July 17, 2009)
» New Cerebral Oximeter from Nonin Granted US OK (July 16, 2009)
» PORT ACCESS System for Mitral Valve Repair Proves Its Value in Study (July 9, 2009)
» Smallest PFO Closure Device Gets EU OK (July 9, 2009)
» Medtronic's New MRI Compatible Pacemaker Gets CE Mark (June 23, 2009)
» Steerable Biopsy Needle Helps Target Difficult Sites (June 22, 2009)
» Artificial Heart Inspired by a Cockroach and Built like an Onion (June 18, 2009)
» St. Jude Medical's Cool Point Irrigation Pump Gets US OK (June 17, 2009)
» EU Issues OK for Minimally Invasive Subcutaneous Implantable Defibrillator (June 16, 2009)
» St. Jude Medical Introduces New ICD-Leads Connector (June 12, 2009)
» Cook Launches Z-TRAK PLUS Introduction System for Zenith TX2 TAA (June 12, 2009)
» World's Smallest TEE Probe Goes Multiplane (June 9, 2009)
» Edwards Touts Results of SAPIEN Valve Study (May 21, 2009)
» Medtronic's CoreValve Transcatheter Aortic Valve Replacement System Performs Well in Trial (May 20, 2009)
» Positive Results for Medtronic's MRI-Safe Pacemaker (May 14, 2009)
» Digital Subtraction Angiography on a Single Image (May 14, 2009)
» SJM Gets FDA OK for New AICDs (May 11, 2009)
» Edwards Announces New Cardiac Offerings (May 11, 2009)
» SJM Gets US Green Light for Adjustable Annuloplasty Ring (May 11, 2009)
» Minimally Invasive Aortic Valve Replacement With the Lotus System (May 8, 2009)
» NASA Super Plastic in Medtronic CRT (May 7, 2009)
» Magnus Operating Table from Maquet (May 4, 2009)
» FDA OK'es Impella 5.0 and Impella LD Circulatory Assist Devices (April 27, 2009)
» First Clinical Trial Implantatation of C-Pulse Heart Assist System (April 22, 2009)
» EU Green Lights SJM's Newest ICDs (April 22, 2009)
» Toronto XVIVO Lung Perfusion System for Better Organ Preservation (April 17, 2009)
» STARFlex Septal Repair Implant Gets US Green Light for VSDs (April 14, 2009)
» da Vinci Surgical System Now in Enhanced 3D HD (April 6, 2009)
» Percutaneous MitraClip System Debuts In Europe (April 3, 2009)
» Cardinal's Endura Scrubs for the Modern Clinician (March 19, 2009)
» Exchangeable Cardiac Valves from ValveXchange (March 19, 2009)
» Impella 2.5 Heart Pump Performs Well in a Feasibility Trial (March 12, 2009)
» AngelMed Guardian System Aims to Predict Heart Attacks (March 11, 2009)
» REPEL-CV Bioresorbable Cardiac Adhesion Barrier Wins FDA Approval (March 9, 2009)
» MRI May Replace X-Rays for Catheterizations (March 3, 2009)
» SAPIEN Transcatheter Cardiac Valve Trial Going Ahead (February 12, 2009)
» Study Initiated to Trial Tiny MR Repair Clip (February 2, 2009)
» Minimally Invasive CARILLON Mitral Contour System Gets EU OK (February 2, 2009)
» A New Driver System for CardioWest Artificial Heart (January 22, 2009)
» BioControl Medical Gets CE Mark for CardioFit System for CHF (January 7, 2009)
» Amimon's High Definition Wireless Video Goes Clinical (January 5, 2009)
» Subcutaneous Implantable Cardiac Defibrillators (November 26, 2008)
» TruSystem 7500: New OR Table from TRUMPF (November 21, 2008)
» CollaRx Gentamicin Surgical Implant Gets FDA Fast Track Designation (November 21, 2008)
» CARDIOHELP, World's Smallest Bypass Machine (November 5, 2008)
» PlasmaBlade Finds New Uses With New Attachments (October 29, 2008)
» New Artificial (Carpentier?) Heart Going to Trial (October 28, 2008)
» In The Works: Echocardiography-guided Mitral Valve Repair Without a Bypass (October 23, 2008)
» Talent Stent Graft with the New Delivery System Goes on Sale in US (October 23, 2008)
» "Never Events" Prevented With SurgiCount Safety-Sponge System (October 8, 2008)
» CentriMag Right Ventricular Assist Device Gets Humanitarian Device Exemption (October 7, 2008)
» AneuGraft Stent from ITGI Medical Wins Approval in Europe (October 3, 2008)
» Want to Get CATANIA Coronary Stent? Go to Europe! (October 2, 2008)
» HeartWorks 3D Computer Generated Transesophageal Echo Simulator (September 30, 2008)
» St. Jude's Confirm Implantable Cardiac Monitor Wins FDA Approval (September 12, 2008)
» Solex Goes for The Jugular: New Heat Exchange Catheter Gets FDA OK (September 10, 2008)
» Edwards PERIMOUNT Magna Mitral Valve Gets FDA's Green Light (September 8, 2008)
» FDA Gives Green Light to Genetic Heart Transplant Test (August 27, 2008)
» Epicor HIFU Ablation System Wins US, EU Approval (August 22, 2008)
» DuraHeart Begins US Trials (August 21, 2008)
» ATS Medical Gets CE Mark for CryoMaze Surgical Ablation System (August 19, 2008)
» The Sternal Talon: Is It a Chest Zipper or Is It Body Armor? (August 13, 2008)
» REPLY, World's Smallest Pacemaker OK'ed in USA (August 8, 2008)
» Force-feedback Offerings from Haption (July 28, 2008)
» PlasmaBlade System Gets FDA Go Ahead (July 24, 2008)
» Zenith TX2 TAA Endovascular Stent Available in US (July 14, 2008)
» Implantable Heart Monitor May Provide Real Time Cardiac Data (July 2, 2008)
» Over and Under Pericardium Covered Stent from ITGI Medical (June 24, 2008)
» Blood Coagulation Testing Device Under Development (June 23, 2008)
» Loyola University Hospital Loves Their Magnetically Navigated Heart Catheter System (June 19, 2008)
» Attain StarFix Lead Approved in US (June 17, 2008)
» Talent Thoracic Stent Graft System Approved in US (June 6, 2008)
» Acuity Spiral Lead Given US Approval (June 2, 2008)
» Impella 2.5 Heart Pump Given Green Light in US (June 2, 2008)
» Boston Scientific Receives Approval for Two New Defibrillators (May 22, 2008)
» Profile 3D Mitral Annuloplasty Ring Launched in US (May 21, 2008)
» Study: Riata High-Voltage Leads Show "Performance and Reliability" (May 15, 2008)
» Medtronic 3D Vision Line Gets First FDA Approvals (May 14, 2008)
» Novel Surgical Biomaterial Receives Regulatory Approvals (May 14, 2008)
» Synergy Pocket Circulatory Assist Device Does Well in Early Trial (May 13, 2008)
» Boston Scientific ALTREA Pacemaker EU Approved (May 7, 2008)
» Peak PlasmaBlade Wants to Be The New Bovie (May 7, 2008)
» FDA Approves Thoratec Heart Pump (April 22, 2008)
» Edwards Trials Company's Minimally-Invasive Pulmonic Valve (April 18, 2008)
» HEARTSTRING III Proximal Seal System for CABG (April 14, 2008)
» Improved Atrial Fibrillation Ablation Technique (April 8, 2008)
» Abiomed AB5000 Portable Circulatory Support Console Approved in Europe (March 28, 2008)
» Ornim Oxygen Saturation System FDA Approved (March 20, 2008)
» Impella Percutaneous VAD to be Studied for Acute MI Patients (March 17, 2008)
» REPLY, World's Smallest Pacemaker OK'ed in Europe (March 11, 2008)
» Edwards Sapien Transcatheter Aortic Valve Makes Human Debut (March 10, 2008)
» FloWave 1000 Monitor Promises Noninvasive Cardiac Output (March 7, 2008)
» Motorized Fabric for Cardiac Assistance (February 14, 2008)
» CryoValve Approved by FDA (February 8, 2008)
» German Team Wants to Improve Safety of VADs (February 4, 2008)
» OrNim's Targeted Oximetry (January 30, 2008)
» New OR Computer and JOCAP XL Program from MAQUET (January 29, 2008)
» SPY Intra-operative Imaging System for Graft Assessment (January 29, 2008)
» German-made Heart Pump for Children Needing Heart Transplants (January 21, 2008)
» HeartNet™ Procedure for CHF (January 18, 2008)
» ATS Heart Valve Receives Approval (December 18, 2007)
» In the Works: Light-guided Transluminal Catheter (December 6, 2007)
» Endovascular Talent™ for AAAs (December 5, 2007)
» St. Jude Medical Scores with the FDA on Valves with Anti-Calcification Technology (November 28, 2007)
» Acuson P50 Portable Ultrasound System from Siemens (November 28, 2007)
» Artis zee from Siemens (November 26, 2007)
» The i60 Robotic Articulating Endoscopic Linear Cutter (October 26, 2007)
» REVA Bioresorbable Polycarbonate Stent (October 19, 2007)
» The Myotech Circulatory Support System (CSS) (October 11, 2007)
» Tissue-Engineered Blood Vessels Perform Well in a Study (October 9, 2007)
» Corset for Congestive Heart (October 9, 2007)
» St. Jude's Promote™ RF CRT-D and Current™ RF ICD (September 25, 2007)
» ThermoSuit, a Hypothermia Water Immersion System, Approved in the EU (September 19, 2007)
» Ultrasound That Seals Punctured Lungs (September 14, 2007)
» Tissue-Engineered Heart Valves That Grow with Patient (September 11, 2007)
» In the Works: Ultra-Miniature Surgical Instruments (September 10, 2007)
» HeartMate II Shown Effective In Waiting Transplant Candidates (August 30, 2007)
» Melody™ Transcatheter Pulmonary Valve Still Being Tested in the US (August 23, 2007)
» Safety Issues Eat Away at Stent Makers (August 16, 2007)
» New Trial for CardioFit™ System for CHF (August 1, 2007)
» Virtual God Complex: Video Game Training for CT Surgeons (July 31, 2007)
» PediaFlow™ Ventricular Assist Device (July 16, 2007)
» Noninvasive Pneumothorax Detector (July 10, 2007)
» MEMS-based Pressure Systems from ISSYS (July 10, 2007)
» Watching the Watchman (June 18, 2007)
» Medtronic Begins 8800 Patient Study on Drug-Eluting Stents (May 22, 2007)
» Percutaneous VSD Patch Results Presented (May 11, 2007)
» Zephyr™ Pacemakers from St. Jude (May 4, 2007)
» The HeartLander, a Bug for the Heart (April 19, 2007)
» New Defibrillator Features AF Suppression Technology (March 20, 2007)
» Talent™ Thoracic Stent Graft System (March 5, 2007)
» Novalung® iLA Membrane Ventilator (February 15, 2007)
» The CardioFit™ System for CHF (February 12, 2007)
» LAP Mentor™ and other Sims from Simbionix (February 9, 2007)
» Artificial Cardiac Valves Face the Curdled Milk Test (February 7, 2007)
» The Melody™ Valve Approved in Canada (January 10, 2007)
» Canadian Receives HeartMate II Non-Pulsatile LVAD, Eh? (December 14, 2006)
» Technology Helps Predict Outcome of Pediatric Heart Surgery (November 29, 2006)
» Watchman®: Plug Up Heart to Prevent Strokes (November 29, 2006)
» Defibrillator Design Tool: Play-Doh (November 15, 2006)
» Apple Solution for DeBakey VAD (October 31, 2006)
» Gelling Up Artificial Grafts (October 19, 2006)
» H2S Offers Hope in Total Circulatory Arrest (October 10, 2006)
» The Melody™ Transcatheter Pulmonary Valve (October 5, 2006)
» MPH® Hemostatic Technology (October 3, 2006)
» Acuson AcuNav 8F (October 2, 2006)
» An Artificial Heart That Doesn't Beat (September 22, 2006)
» AbioCor Illustrated (September 13, 2006)
» The Arctic Sun® (September 13, 2006)
» More on Abiomed's Artificial Heart (September 7, 2006)
» First Self-Contained Artificial Heart Receives an FDA Exemption (September 6, 2006)
» Cerebral Embolic Protection by Ultrasound (August 28, 2006)
» Live Surface, A Software for Surgeons (August 2, 2006)
» The MYO-VAD™ (July 17, 2006)
» CMS to Release Heart Defibrillator Implants' Data (July 13, 2006)
» TransMedics in the Science Museum (July 10, 2006)
» AS-Port® Proximal Anastomosis System (June 29, 2006)
» The New Octopus® for Beating-Heart Surgery (June 29, 2006)
» Exeleras® System: An Implantable Pump for Chronic Heart Failure (June 28, 2006)
» Ultrasound Technology for Counting Emboli (June 26, 2006)
» First Patient with VentrAssist (June 22, 2006)
» Hopkins Students Close Chest with Zip Ties, Think They're So Smart (June 8, 2006)
» UK's First Beating Heart Transplant (June 5, 2006)
» Merlin™ Patient Care System (June 1, 2006)
» Medtronic Concerto™/Virtuoso™ Debut (May 17, 2006)
» Telling Us Before there's a Problem: Boston Scientific Releases Physician Communications (May 15, 2006)
» Medical Heart Pumps from HeartWare: HVAD, MVAD and PedVAD (April 26, 2006)
» The Medtronic Performer™ CPB (April 21, 2006)
» The MitraClip™ (April 20, 2006)
» The CardioWest™ TAH-t (April 7, 2006)
» No Increased Risk from Recalled Defibrillators (March 17, 2006)
» Rotary VAD From WorldHeart Debuts (March 15, 2006)
» SpideRX Embolic Protection Device Receives FDA Approval (February 21, 2006)
» In the Works: Collapsible Heart Valve for Children (February 16, 2006)
» Impella Recover Devices Approved in Germany for Reimbursement (February 8, 2006)
» The BioGlue® (January 25, 2006)
» TandemHeart PTVA® System (January 23, 2006)
» Bare Metal Stents Show Promise for Restenosis Prevention (January 4, 2006)
» Robotic Surgery and Stenting for Coronary Artery Disease (CAD) (November 22, 2005)
» Lack of IV Access? Grow Your Own (November 16, 2005)
» The Slurry Fury (November 15, 2005)
» Heart-Lung Machine Improvements (November 14, 2005)
» The EndoSure™ Wireless AAA Pressure Measurement System (November 11, 2005)
» HeartPOD™ (November 3, 2005)
» Victory® Pacemakers (October 28, 2005)
» Cancion® CRS™ Cardiac Recovery System (September 22, 2005)
» CryoCor™ Cardiac Cryoablation System (August 25, 2005)
» HeartMate® II Left Ventricular Assist System (July 19, 2005)
» The PediPump™ (July 12, 2005)
» Simultaneous Hybrid Procedure for CAD (July 5, 2005)
» Second Patient Receives VentrAssist (June 29, 2005)
» The Sunshine Heart C-Pulse (May 23, 2005)
» Ready System allows Mini-Bypass (May 19, 2005)
» Surgical-Assist Robots by Armstrong Healthcare (May 17, 2005)
» GORE TAG Endoprosthesis System for Descending Thoracic Aneurysms (March 28, 2005)
» The BioScanIR System (March 23, 2005)
» Berlin Heart EXCOR (March 14, 2005)
» 'Surgical aid sees into the future' (February 22, 2005)
» Zenith TX2 Thoracic TAA Endovascular Graft (February 17, 2005)
» VentrAssist LVAS (February 9, 2005)
» 'Mini' Bypass: The Ready System 200 (February 1, 2005)
» SPY™ Intra-operative Imaging System for CABG (January 26, 2005)
» INR@Home (January 21, 2005)
» VirtuoSaph™ Endoscopic Vein Harvesting System (January 21, 2005)
» InSync Sentry: defibrillator and CHF monitor (January 17, 2005)
» New Linear ™ 7.5 Fr. Intra-Aortic Balloon (January 11, 2005)
» Signals From Deep Inside (December 28, 2004)
» High Intensity Focused Ultrasound for AFib (December 23, 2004)
» impella® recover LV (December 11, 2004)
» Evalve Percutaneous MV Repair System (December 11, 2004)
» CorCap (December 10, 2004)
