Friday, November 20, 2009
Let Draeger Polaris Be Your Guiding Light
We are continuing to profile the latest gadgets that are being showcased at the Medica 2009 in Düsseldorf. This beautiful line of cold OR light systems, appropriately dubbed Polaris, comes from Drägerwerk AG & Co., a company better known to everyone as Dräger.
Details from the press release:
Compared with conventional light sources, the smaller LEDs of the Polaris system are considerably more energy-efficient than conventional light sources. An LED light source has a life span of about 30,000 hours (corresponding to about seven to ten years of service life in the operating room), while the life span of a conventional light source is about 1,000 hours (corresponding to about four months of service life in the operating room). The slight amount of lost heat from the LEDs is dispensed through the top of the housing.The different Polaris models are distinguished by their illuminating power. They can be used as an individual OR light or as a satellite in multiple-light systems, and can also be equipped with an integrated camera.
This new product design received the red dot design award 2008 which, according to the Design Zentrum Nordrhein Westfalen, is based on criteria such as innovation, functionality, quality and ergonomics.
The 108 light-emitting diodes of the Polaris (700 model) distribute light with a color temperature of 4,600 Kelvin. "Cold light" (without long-wave infrared content) is generated by means of a phosphor layer on the semiconductor and focused via an optical system. The LEDs are installed in the reflectors in pairs.
The individual light paths form a light cylinder which has an illumination depth of about 1,100 millimeters and a variable diameter of 220 to 290 millimeters. This ensures that the light of each LED can be focused on the OR field and that several surgeons can work simultaneously on the OR field without noticeably reducing the brightness.
Press release: Precision lighting with the new Dräger Polaris...
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Monday, November 16, 2009
HeartWare Heart Pump Shows Positive Results in Clinical Study
HeartWare, a Framingham, Massachusetts maker of an innovative left ventricular assist system, released results of a European trial testing the survival rates in patients who've been implanted with the device. Just like other ventricular assist systems, HeartWare® is designed to provide a bridge to heart transplantation.
Our friends over at MassDevice report on the findings:
Data collected from a 50-patient trial aimed at winning CE Mark approval in the European Union (which was granted in January) showed a six-month survival rate of 90 percent, according to a regulatory filing. Two years after implantation the survival rate was 84 percent. Patients 60 years and older had a survival rate of 93 percent.The study also showed an 80 percent reduction in post-implantation re-hospitalizations in the 12 months after the procedure, compared with the 12 months preceding implantation.
More from MassDevice...
Link: HeartWare regulatory filings at the SEC...
Product page: HeartWare® Ventricular Assist System...
Flashback: Medical Heart Pumps from HeartWare: HVAD, MVAD and PedVAD
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Thursday, November 12, 2009
FDA Grants Vascular Solutions Clearance for The GuideLine Catheter
US FDA has given 510(k) regulatory clearance to Vascular Solutions Inc., a 
Minneapolis, Minnesota firm, to market the GuideLiner™ catheter. The device, designed to provide a coaxial guide extension and rapid exchange for coronary or peripheral interventions, comes in 6F, 7F, 8F (Freedom Fries) sizes and is delivered through standard guide catheters, hence it allows physicians to use "standard length guidewires, balloons or stents through an existing hemostatic valve," according to the company.
From the press release:
The GuideLiner is a unique coaxial “mother and child” guide extension with rapid exchange convenience that provides back-up support and selective deep intubation in challenging coronary interventions. The GuideLiner catheter will be available in 6, 7 and 8 French sizes as part of Vascular Solutions’ specialty catheter product line. CE mark clearance of the GuideLiner was received and European sales and clinical uses commenced in October, with the U.S. launch of the GuideLiner catheter expected to commence in November through Vascular Solutions’ direct sales force.Dr. Douglas Fraser, an Interventional cardiologist with Manchester Heart Centre in Manchester, United Kingdom, commented on his initial clinical experience with the GuideLiner: “Deep intubation of the Guideliner catheter within a soft 6F guide provides better backup support and is less traumatic than using stiff 7F and 8F guides that were previously required in complex disease. Furthermore, the soft and very flexible tip will often cross tortuous disease where a stent gets stuck, enabling delivery of stents and other equipment directly to the target lesion. The GuideLiner is as easy to insert as a standard rapid exchange balloon catheter and has quickly become a routine part of my angioplasty practice.”
Dr. Colm Hanratty, an interventional cardiologist at Belfast City Hospital in Belfast, Ireland, commented on one of his initial clinical uses of the GudieLiner: “In this patient, despite modification of the diseased segment and subsequent pre-dilatation, we could not track a 3.0 mm stent across the lesion due to significant friction in the proximal vessel. We then passed a 6F GuideLiner into the vessel and by removing the proximal resistance we could then deliver the 3.0 mm stent, followed by a 4.0 mm stent and post-dilatation with a 4.0 mm balloon. Deep intubation with the Guideliner facilitated delivery, allowed us to optimize stent apposition and also improved visualization of the vessel due to selective cannulation.”
Product brochure: GuideLiner Catheter...
Product page: GuideLiner Catheter ...
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Tuesday, November 10, 2009
A New LED Powered Endoscope from Schölly
Schölly Fiberoptic out of Denzlingen, Germany is releasing a new video bronchoscope with CMOS "chip-in-the-tip" and bright LED technology. The device is going to be unveiled at MEDICA 2009 next week in Düsseldorf.
The controller unit is plug-and-play with easy start-up. Its compact size saves table space and the simple controls eliminate the need for lengthy training. The controller is completely silent since it does not require a cooling fan. All video settings are preprogrammed, so no complicated and time consuming set-up is necessary. A single cable leads from the controller to the ergonomic handpiece. The handpiece includes the tip deflection lever, working channel port, suction valve, and buttons for taking photos and illumination adjustment. High-powered LEDs are incorporated inside the handpiece. These LEDs eliminate the need for costly replacement bulbs.
Link: Innovative New Video Bronchoscope with DeepVu Technology ...
(hat tip: German Healthcare Export Group)
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Melody Transcatheter Cardiac Valve Replacement Shows Good Results in Children
Cardiologists from Miami Children's Hospital, Morgan Stanley Children's Hospital, New York, and Children's Hospital Boston just published preliminary results from the study of Medtronic's Melody® Transcatheter Pulmonary Valve in 34 children and young adults who were implanted with the device for dysfunctional right ventricular outflow tract conduits. The early results are promising and may help the Melody valve get approved in the US as the first transcatheter cardiac valve on the market.
All patients underwent cardiac catheterization with the intention of implanting the artificial valve, and 30 of the 34 underwent actual implantation attempts, of which 29 were successful. Three patients (9 percent) had complications during implantation, but all survived.At follow-up six months later, no patient had more than mild pulmonary regurgitation. Of 24 patients who had Class II or III heart failure (mild to moderate limitation of physical activity) before the procedure, 19 had improved by at least one functional class at six months, and no patient's function had declined.
Eight of the 29 devices developed partial fractures during follow-up, and 3 patients required a second Melody valve (inserted inside the first one) for recurrent blockage.
Children's Hospital Boston press statement: Catheter-delivered Valve May Help People with Heart Defects Avoid Multiple Surgeries; Medtronic statement: Melody® Transcatheter Valve Demonstrates Encouraging Results in Study on Patients with Congenital Heart Disease...
Abstract in Journal of the American College of Cardiology: Implantation of the Melody Transcatheter Pulmonary Valve in Patients With a Dysfunctional Right Ventricular Outflow Tract Conduit ...
Product page: Melody® Transcatheter Pulmonary Valve and Ensemble® Transcatheter Delivery System ...
Flashbacks: Medtronic's Melody Transcatheter Pulmonary Valve on Track for Approval ; Melody Transcatheter Pulmonary Valve Still Being Tested in the US ...; The Melody Valve Approved in Canada; The Melody Transcatheter Pulmonary Valve
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Monday, October 26, 2009
TRUMF's OR Table Integrated With Siemens Multi-axis Fluoroscopy Systems
Siemens has just announced that it has integrated the TruSystem 7500 OR table from TRUMPF (Puchheim, Germany) with its Artis zee and Artis zeego fluoroscopy scanners. The TruSystem 7500 adjusts to just about any position imaginable and is transparent to x-rays, and so can be used in almost any surgical or invasive radiological procedure. TruSystem 7500 OR table is illustrated above, and Artis zeego multi-axis interventional fluoroscope is shown in the picture below.
The Trumpf OR table has been designed especially for this integration and is equipped with a onepiece carbon tabletop, which can be replaced by a segmented universal tabletop. The table column enables the two tops to be exchanged easily. The carbon tabletop is transparent to X-rays and thus ensures that there will be no disruptive artifacts in the images. It is suitable for interventional procedures and minimally invasive surgery. The integration of the OR table with the Siemens angiography systems also make fast rotations and 3-D imaging possible with the surgical C-arm. The modular design of the segmented tabletop enables extremely flexible positioning of the patient, particularly important in orthopedics and neuro surgery. Complicated positions, such as the chest side position, can be achieved quickly with great precision as well as comfort for the patient and staff.
Along with the integrated Trumpf OR table, Siemens continues to offer its Artis tables for the entire Artis zee series, which are available in three designs: as a standard table, a table with Trendelenburg tilting and one with Trendelenburg and lateral tilting.
Press release: Siemens integrates Trumpf's OR table in its Artis zeego and Artis zee ceiling angiography systems...
Product pages: TruSystem 7500, Artis zee, Artis zeego
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Wednesday, October 21, 2009
ThumBlade Scalpel Safety System
Here's an interesting new take on improving the safety for scrub techs, nurses and surgeons. ThumBlade™ scalpel system from Precision Medical Devices Inc. (Marlboro, NJ) is a no contact, disposable safety sheath that covers blades, and allows activation of the scalpel with just one hand. So no more sharps and no more mosquito use to mount a blade.
Medgadget has obtained the following details about the device:
Featuring patent pending innovative thumb activation independent mechanisms, PMD’s ThumBlade™ safety scalpels enable one-handed activation smoothly and safely by right or left handed practitioners with no contact with the exposed blade. This activation affords an easy, natural opening motion while keeping the other fingers out of the way. The safety sheath is made from high quality ABS composite with a completely flat and smooth top, providing a stable platform for better control during the procedure. The extra sharp blades are stainless steel, pre-sterilized, and disposable after single use. The blade sheaths and packaging are color coded by size for easy counting and safe use. The stainless steel handles are pre-sterilized for first use and can be re-sterilized and re-used. These handles, available in both #3 and #4 fitments, are premium length and back-weighted for the grip and feel practitioners prefer.
Product page: ThumBlade™ safety scalpel system...
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Monday, October 19, 2009
Mobile Driver for CardioWest Artificial Heart Gets EU OK
After review by the British Standards Institution (BSI), the European Union has granted SynCardia (Tucson, Arizona) approval to market the Companion Driver System to power the firm's temporary CardioWest™ Total Artificial Heart. The unit provides the ability to discharge certain patients home while they are waiting for a transplant.
“The new fleet of Companion Drivers will supplement the 36 ‘Big Blue’ hospital drivers currently in use, more than tripling implant capacity by year-end,” said Rodger Ford, SynCardia CEO and President. “The Companion Driver will also supply the drivers we need to train the backlog of transplant centers waiting to become certified on the Total Artificial Heart.”Proven Process Medical Devices, one of the largest medical Original Equipment Manufacturers in the world, has committed to producing 85 Companion Drivers by year-end, in addition to Hospital Carts for the OR/ICU and portable caddies for stable patients.
The Companion Driver is also designed to power SynCardia’s future family of pulsatile devices, including the 50cc Total Artificial Heart and the 10cc, 30cc and 60cc ventricular assist devices (VADs).
In October, SynCardia submitted a Pre-Market Approval Supplement to the FDA for approval of the Companion Driver in the U.S.
Press release: SynCardia's Companion Driver System Receives CE Mark to Power Total Artificial Heart in Europe...
Flashback: A New Driver System for CardioWest Artificial Heart
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Thursday, September 24, 2009
Abiomed Reports New Positive Impella 2.5 Results
The latest results from trials examining Abiomed's Impella 2.5 Percutaneous Circulatory Support System, the world's smallest left ventricle heart pump, are in, and they give the company, us and hoping clinicians a happy feeling. The big hurdle that the company has to overcome is to convince cardiologists that Impella devices are easy to place under difficult circumstances (such as developing high-risk PCI, MI in cath lab, failing ventricle), and are safe for patients. Also, Abiomed has to prove to cardiologists that Impella provides a clinical advantage versus intraaortic balloon pumps (IABP), when a patient's heart is failing and needs an emergency ventricular support in the cath lab. On both of these points, it seems the company scored positive results in the latest trials.
From Abiomed's press office:
USpella [is] the first U.S. multicenter registry of Impella 2.5 patients evaluating the safety and feasibility of left ventricular support with the Impella 2.5 during high-risk percutaneous coronary intervention (PCI) and treatment of acute myocardial infarction (AMI).High-Risk PCI patient results in USpella
In 64% of the high-risk PCI cases, the patients had been turned down for CABG before treated with Impella 2.5
The high-risk PCI population presented with a more complex anatomy than the SYNTAX trial population (of 23), decreasing SYNTAX score from 38 to 18 after effective revascularization with Impella 2.5
Registry results reaffirmed ejection fraction increases that were similar to PROTECT I results, with improved ejection fraction in USpella high-risk PCI patients increasing from 29 to 34, after Impella 2.5 support
Reported overall MACE was low at 6%
30-day survival rate was 97% AMI patient results in USpella
Impella was used after conventional therapies failed, (88% after emergent revascularization; 88% after high-dose inotropes; 68% after IABP therapy
Impella improved hemodynamics in AMI shock patients, improving cardiac index from 1.9 to 2.5 l/min/m2, increasing mean arterial pressure from 62 to 87 mmHg, and decreasing wedge pressure from 28 to 20 mmHg, as well as decreasing overall Systemic Vascular Resistance (SVR)
After Impella 2.5 support, overall ejection fraction in AMI patients improved from 29 to 37%;
Impella successfully supported AMI refractory shock patients with 69% survival to the next therapy or onto recovery. Also, 58% of AMI shock patients and 89% of AMI patients with no shock were discharged
The MACH II trial, evaluating safety and feasibility in STEMI, included 20 patients; ten patients were treated with three days of Impella 2.5 support; ten control patients were treated with routine standard of care. The initial four-month results, which demonstrated significant recovery of left ventricular function in Impella 2.5 patients, were published in the Journal of American College of Cardiology in 2008.All patients were measured in an IRB-approved protocol that calculated echo results, exercise testing and quality of life, and showed the following results from core laboratory analysis and strict processes:
Left ventricular ejection fraction in Impella 2.5 patients increased from 28% at the baseline, to 41% in the four-month analysis, to 51% at the three-year follow-up period. Left ventricular ejection fraction in the control patients increased from 40% at the baseline, to 45% after the four-month analysis to 47% at the three year analysis. Impella 2.5 patients continued to show improvement in left ventricular ejection fraction, demonstrating a net increase of 23 ejection fraction points while control patients only showed a net increase of 7 ejection fraction points.
Significant benefit in exercise capacity was demonstrated stronger by Impella 2.5 patients, than control patients, which also improves the quality of life for the patient
Impella 2.5 patients saw no effects on aortic valve at three-year follow-up
Press releases: Abiomed Presents Results from USpella; First U.S. Registry Data Evaluating 181 Patients from 16 Centers with IRB Approval...; Abiomed Reports Results from Academic Medical Center's Three-Year Follow-up of MACH II Trial...
More thoughts from MassDevice...
Flashbacks: Impella 2.5 Heart Pump Performs Well in a Feasibility Trial; FDA OK'es Impella 5.0 and Impella LD Circulatory Assist Devices; Impella 2.5 Heart Pump Given Green Light in US; Impella Percutaneous VAD to be Studied for Acute MI Patients; impella® recover LV
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Monday, September 21, 2009
New Surgical Glue from Lifebond to Offer a Stronger, Tighter Seal
Lifebond out of Caesarea Industrial Park, Israel has developed a new surgical sealant which is apparently stronger than the currently used blood-derived fibrin glues. The LifeSeal SLR staple line reinforcement sealant and LifeSeal Surgery sealant 
for general surgery are two main products from the company that are based on its proprietary hydrogel matrix technology, in which individual protein molecules tend to cross-link and form fibrin-like networks. The company plans to ask for US and European approval to market the material next year.
LifeBond's technology functions through the rapid and biocompatible in situ cross-linking of structural proteins. As they cross-link, proteins in the physiological environment undergo a process of gelation to form an adhesive hydrogel matrix. The properties of the cross-linking reaction and the hydrogel matrix can be controlled to fit a variety of applications.LifeSeal GI is comprised of LifeBond sealant provided in a specialized two-component applicator syringe. The mixed sealant is applied to anastomosis staple-line junctures in the GI tract to fortify the attachment and prevent leakage until full function is restored. The applicator thoroughly mixes the two components as they are applied and evenly dispenses the sealant onto the staple-line juncture. The sealant can be applied manually or as a gas-assisted spray.
Application of LifeSeal GI onto the staple line moderates tension on the staple line because it stabilizes the tissue sections in relation to each other and adds adhesive strength to the junction. Furthermore, LifeSeal GI seals off the staple holes and narrows the spaces in between each staple. Thus, leakage, bleeding, and tearing at the staple line can be reduced, especially in diseased and fragile tissue.
LifeSeal Surgical sealant is provided in a variety of specialized two-component applicators. The mixed sealant is applied to a wound site or staple-line juncture to prevent fluid or blood leakage until full physiological function is restored. The applicator thoroughly mixes the two components as they are applied and evenly dispenses the sealant onto the wound site or staple-line juncture. The sealant can be applied manually or as a gas-assisted spray. The precise application method can be altered to optimize sealant use for specific applications.
Links: Lifebond technology page; LifeSeal SLR; LifeSeal Surgery
(hat tip: ISRAEL21c)
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Friday, September 18, 2009
Sensei X Robotic Catheter System for Electrophysiology Procedures
Hansen Medical out of Mountain View, California has just announced that it received FDA approval for the company's next generation Sensei® X Robotic Catheter System, a navigation assistance technology for cardiac electrophysiologists. The company is also introducing a new ablation catheter called Artisan Extend™ that sports, according to the company, "advanced navigational capabilities and the flexibility required to reach difficult-to-access cardiac anatomy while maintaining stability during complex cardiac arrhythmia procedures." And to cap up the news, the company will be releasing the new Lynx Robotic Ablation Catheter to the European market.
The Sensei X platform provides force feedback, giving physicians the ability to precisely control the distant tip of the catheter, and to feel when the catheter is penetrating cardiac tissue.
The new Sensei X system is the next generation flexible robotic platform that integrates advanced levels of 3D catheter control with 3D visualization, a synergistic technology combination that provides accuracy and stability to the physician. The Sensei X platform supports the new Artisan Extend control catheter, which increases the reachability and navigation properties of the existing Artisan catheter by offering more than 20 percent improvement in both bend and reach. As a result, physicians have the ability to place catheters deliberately and accurately within the heart. In addition, the Artisan Extend catheter offers improvements in setup and workflow, designed to improve usability and reduce procedure time.The Sensei X platform also supports Hansen Medical's CoHesion(TM) 3D Visualization Module, which integrates the 3D motion control of the Sensei X system with the 3D visualization of the St. Jude Medical EnSite(TM) system. Two features of the Sensei X system designed to improve procedural planning and workflow include Workspace Visualization, an enhancement that allows physicians to see the catheter's reach on a 3D map prior to navigation, and EndoView, a feature that allows physicians to quickly change the orientation to a standard endoscopic view.
The new Lynx robotic ablation catheter, which the company plans to launch in the European market, is supported by the Sensei X platform and leverages the navigation capability of the Artisan Extend catheter, but in a smaller and more flexible integrated profile for the treatment of atrial fibrillation (AF) and other electrophysiology disorders. Offering a seven French irrigated ablation tip with a standard sized sheath, the new Lynx catheter has six degrees of freedom that facilitates placement in difficult to reach anatomic locations. Pending CE Mark approval, the Lynx catheter is expected to be available in the European Union within the first half of 2010. The Lynx catheter is not currently available for sale in the U.S.
Press release: Hansen Medical Unveils Next Generation Robotic Catheter System and Two New Catheters Offering Advanced Navigation Within the Heart...
Product page: Sensei® X Robotic Catheter System...
Product brochure: Artisan Extend™ Control Catheter...
Flashbacks: The Sensei™ Robotic Catheter System ; Cardiac Electrophysiology Goes Robotic and 3D with CoHesion™
Animation showing off the Sensei X system below the fold:
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Monday, September 14, 2009
Under Development: Pneumatic Heart Pump for Minimally Invasive Delivery
Researchers at the Vienna University of Technology (Technische Universität Wien) have developed a prototype pneumatic ventricular assist pump that is almost small enough to be delivered percutaneously via a catheter. The current model is only about 10 mm wide and 90 mm long, which means that a clinically useful device would have to be half the size. The development of the new device was commissioned by Werner Mohl, a clinical professor of cardiac surgery at TU Vienna.
“The aim was to avoid the development of heat which is caused by heart pumps that are driven by an electric motor. The heat which is produced is transferred to the blood. Professor Mohl approached us with a request to construct a pump with pneumatic air propulsion which doesn’t have to be cooled”, explains project manager and associate professor Margit Gföhler from the Institute for Engineering Design and Logistics Engineering at the TU Vienna.Assistant professor and project colleague Helmut Mad adds: “The heart catheter pump is intended for temporary bridging after an operation or after a heart attack. It is supposed to be used for a maximum of five to ten days. The pump is powered with compressed air via a tube. Of course, the blood which is transported is hermetically separated from the compressed air. The target capacity should be five litres per minute.” With its technical benchmark data, the heart catheter pump is a very challenging activity from a construction point of view. Gföhler: “Given its size, it is difficult to obtain purchased parts and storage” Special manufacturing and production processes which can be very expensive are required."
A second prototype has now been produced from a ceramic in collaboration with the Institute of Materials Science and Technology of the TU Vienna.
Technische Universität Wien press statement: Heart pump with air propulsion...
Video below the fold demonstrating the pump in action:
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Thursday, August 20, 2009
MAQUET Releases VASOVISION Heads-Up Display for Vessel Harvesting for CABGs
Heads-up displays are best known for their use in fighter jets to help pilots target enemy aircraft. But now MAQUET Cardiovascular out of Wayne, New Jersey has released its own version, the VASOVISION Endoscopic Visualization System, to help surgeons aim at saphenous veins during endoscopic vessel harvesting procedures (EVH) for coronary artery bypasses. Because of the precision required, it can be difficult to operate endoscopic tools while looking at a monitor located in a different field of view from where the instruments are. Hence this new VASOVISION display can be worn during the EVH harvest as it is designed to work with all of the company's VASOVIEW systems.
Here are the features of the display:
Easy to use and lightweight
Comfortable fit for any user
Fingertip adjustments for image brightness and contrast
Central viewing pane provides a wide field of view while enabling peripheral vision
Compatible with all MAQUET VASOVIEW systems
Clear visualization of procedure
Improved comfort and ergonomics during harvesting
Enhanced and streamlined harvesting experience
Press release: VASOVISION Launch...
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Wednesday, August 19, 2009
HeartAssist 5, The Latest DeBakey LVAD, Keeping First Patient Alive
Clinicians at Heidelberg University Hospital in Germany have announced the first implantation of the latest DeBakey LVAD (left ventricular assist device), the HeartAssist 5. The world's smallest machine of its type, the HeartAssist 5 now has approval in the US for pediatric patients and in Europe for both adults and kids. Weighing only 92 grams (3.2 ounces), the unit is made out of titanium and plastic, and provides direct measurement of cardiac output without having to estimate, as in competing devices.
“Following the 3.5 hour surgery, the patient is doing fine,” reports Professor Karck [Dr. Matthias Karck, Director of the Department of Cardiac Surgery at Heidelberg University Hospital]. The 50-year-old woman suffered from heart failure that could not be effectively treated with medication. Since a heart transplant was not an option due to medical reasons, the implanted heart pump will now assist her heart permanently.The DeBakey VAD was first developed in the 1990s in cooperation with NASA by Professor Michael DeBakey, the renowned American cardiac surgeon at the Baylor College of Medicine in Houston, who died in 2008 at the age of 99. The modern version of the device, the HeartAssist 5, is manufactured by US company MicroMed Cardiovascular. It is considered to be a fifth generation VAD because it can be implanted adjacent to the heart and has an exclusive flow probe that provides direct, accurate measurement of blood flow from the left ventricle to the aorta. The new miniature device is light, easy-to-handle and can be monitored and controlled externally.
Press release: Heidelberg Cardiac Surgeons implant world's first new DeBakey Heart Assist Device...
Product page: HeartAssist 5™ Ventricular Assist Device...
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Tuesday, August 11, 2009
Surgem Interactive Surgical Planning Environment for Pedi Hearts
Complicated pediatric cardiac surgeries, such as staged Fontan reconstruction in children born with an univentricular heart, present great challenges when planning for each procedure. Unique anatomies bring unknowns into the physiologic (hemodynamics) equation, often requiring surgeons to make difficult decisions when predicting the outcome of a specific approach. Now scientists at Georgia Tech and clinicians at Children's Hospital of Philadelphia have developed a software tool that analyzes patients' own MRI scans to simulate various possible surgical options and their outcomes.
Georgia Tech reports:
The patient described in this paper, Amanda Mayer, age four, of Staten Island, N.Y., had previously undergone all three stages of the Fontan procedure at The Children’s Hospital of Philadelphia, but developed severe complications. Her oxygen saturation was very low—only 72 percent, compared to normal levels of at least 95 percent—which indicated the possibility of abnormal connections between the veins and arteries in one of her lungs. Normally, the liver releases hormonal factors that prevent these abnormal connections, so the presence of the malformations indicated a low supply of hepatic blood to the lung.The image-based surgical planning consisted of five major steps: acquiring magnetic resonance images of the child’s heart at different times in the cardiac cycle, modeling the preoperative heart anatomy and blood flow, performing virtual surgeries, using computational fluid dynamics to model the proposed postoperative flow, and measuring the distribution of liver-derived hormonal factors and other clinically relevant parameters as feedback to the surgeon.
For this particular patient, the team saw a highly uneven flow distribution—the left lung was receiving about 70 percent of the blood pumped out by the heart, but only five percent of the hepatic blood. Both observations suggested left lung malformations, but closer examination of the flow structures in that particular patient revealed that the competition between different vessels at the center of the original Fontan connection effectively forced all hepatic factors into the right lung even though a vast majority of total cardiac output went to the left lung.
To facilitate the design of the surgical options that would correct this problem, Jarek Rossignac, Ph.D., a professor in Georgia Tech’s School of Interactive Computing, developed Surgem, an interactive geometric modeling environment that allowed the surgeon to use both hands and natural gestures in three-dimensions to grab, pull, twist and bend a three-dimensional computer representation of the patient’s anatomy. After analyzing the three-dimensional reconstruction of the failing cardiovascular geometry, the team considered three surgical options.
The research team then performed computational fluid dynamics simulations on all three options to investigate for each how well blood would flow to the lungs and the amount of energy required to drive blood through each connection design. These measures of clinical performance allowed the cardiologists and surgeons to conduct a risk/benefit analysis, which also included factors such as difficulty of completion and potential complications.
Of the three choices, Spray favored the option that showed a slightly higher energy cost but exhibited the best performance with regards to hepatic factor distribution to the left and right lungs. Five months after the surgery, Mayer showed a dramatic improvement in her overall clinical condition and oxygen saturation levels, which increased from 72 to 94 percent. Mayer is breathing easier and is now able to play actively like other children, according to her cardiologist, Donald Putman, M.D., of Staten Island, N.Y.
Here's a short demo of the interactive surgical planner:
Full story: MRI Simulation of Blood Flow Helps Plan Child's Delicate Heart Surgery...
Abstract in JACC Cardiovascular Imaging: Correction of Pulmonary Arteriovenous Malformation Using Image-Based Surgical Planning
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Tuesday, July 28, 2009
Endoscopic Vein-Graft Harvesting Fight Heats Up
A recent study published in the New England Journal of Medicine has raised a number of questions about the long term patency of endoscopically harvested saphenous veins that are collected and used for coronary artery bypass grafts. The study from Duke, based on a secondary analysis of the PREVENT IV data, concluded that endoscopic vein-graft harvesting is "independently associated with vein-graft failure and adverse clinical outcomes."
Maquet, the maker of the popular Vasoview EVH system, has now fired back saying the study is "subject to a number of important limitations," because it is based on a secondary data analysis. This is of course true, and we do need further randomized clinical tests to evaluate the safety and effectiveness of the endoscopic harvesting technique. But what we also need to realize is that one of the possible reasons that these grafts might be failing in the long term is because the vessels might be experiencing high degree of thermal trauma. Our own editors, in the course of their clinical practice, have seen many endoscopically harvested veins that showed burn marks. Albeit usually tiny in size, these burns probably come from the electrical cutting endoscopic scissors, that are routinely used to remove small side branches from the saphenous vein.
We don't know whether burns play any negative long-term role in the lives of the grafts, or whether they are clinically insignificant. But we have a recommendation for Maquete and other manufacturers. To eliminate any questions about the technique, they should develop small endoscopic clip devices, that can be used to occlude side branches, as well as a regular endoscopic scissors that surgeon can use to cut vessels, once they've been occluded. Sure, this will make the technique more laborious, but it will surely eliminate the thermal factor altogether from the equation.
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Cook's TX2 Pro-Form Thoracic Endograft Gets US Green Light
Cook Medical has received FDA approval to market the Zenith TX2 TAA Pro-Form endovascular graft.
Cook’s new TX2 Pro-Form endograft, which has now obtained FDA approval, utilizes an improved delivery system that allows for carefully controlled deployment of the endograft to help establish proximal conformity of the device to the aortic wall. This innovation in endovascular TAA repair was engineered especially for procedures in which endografts must be positioned in tight aortic arches that are notoriously difficult to seal properly.Many earlier endografts were too rigid or possess sealing stents that lack the radial force to conform correctly to the inner curvature of tight aortic arches, preventing the graft from properly sealing off the aneurysm. Consequently, surgeons have historically been forced to remodel the arch with a balloon or use other aids to position the graft, in an effort to reduce the risk of continued bleeding into the aneurysm and possible rupture. As a result, these difficult repair procedures are often long and complex. The TX2 Pro-Form’s enhanced delivery system may mitigate the need for such additional measures.
Product page: Cook Zenith....
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Monday, July 27, 2009
Medtronic's Melody Transcatheter Pulmonary Valve on Track for Approval
The FDA's Circulatory System Devices Panel has unanimously recommended Humanitarian Device Exemption (HDE) approval of Medtronic's Melody Transcatheter Pulmonary Valve. For now, the device is designed for patients with congenital heart defects, status post open heart surgery, who developed right ventricular outflow tract (RVOT) obstruction.
From Medtronic announcement:
The Melody Transcatheter Pulmonary Valve is the first transcatheter heart valve to be approved for commercial use anywhere in the world and the first to be reviewed by an FDA panel. It received Conformité Européenne (CE) mark, the European regulatory approval, in October 2006, and has been approved for sale in Canada since December 2006. To date, nearly 1,000 patients worldwide have benefited from the Melody Transcatheter Pulmonary Valve. With today’s panel recommendation, the device is on track to become the first transcatheter heart valve of any kind to receive FDA approval for use in the United States.The panel’s recommended conditions of approval include a post-approval study, revision of the patient brochure and instructions for use, and implementation of a physician training and education program.
Patients with a dysfunctional pulmonary valve tire easily, as the heart over-exerts itself trying to get oxygenated blood throughout the body. The condition has traditionally required opening the chest for heart surgery, which is associated with discomfort and significant risks for the patient.
The Melody Transcatheter Pulmonary Valve gives physicians and patients the option to delay the next open-heart surgery. The device is intended to ensure blood flow from the right ventricle to the lungs, and ultimately to the rest of the body. The Melody system may also reduce the cost of treatment by avoiding surgical complications, postoperative intensive care and extended hospital stays.
Press release: FDA Panel Recommends Approval of Medtronic Heart Valve Under Humanitarian Device Exemption...
Product page: Melody Transcatheter Pulmonary Valve and Ensemble Transcatheter Delivery System...
Flashbacks: Melody™ Transcatheter Pulmonary Valve Still Being Tested in the US; The Melody Transcatheter Pulmonary Valve; The Melody Valve Approved in Canada
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Friday, July 17, 2009
VasoNova Gets to The Heart of The Matter
Placement of a peripherally inserted central line so its tip is located at the lower third of the superior vena cava, just prior to the right atrium, is always a guessing game. Nowadays, the only way to confirm position of the line is to do an X-ray of the chest. VasoNova out of Sunnyvale, California wants to change the rules of the game. The company is introducing a device that uses Doppler ultrasound to monitor direction of blood flow and ECG to help position the catheter at the optimal location.
The VasoNova VPS consists of several components: the VPS Stylet, the VPS Power Injectable PICC catheter and the VPS Console.The VPS Stylet contains two sensors at its tip: a Doppler Ultrasound sensor and an intravascular ECG lead. Due to the ingenuity of our R&D group, VasoNova was able to miniaturize the two sensors and construct a highly technical and flexible stylet that can fit into the lumen of the VPS Power Injectable PICC line with comparable dimensions to other market available PICC lines12. Once the VPS stylet is loaded into the VPS catheter and connected to the VPS console per the Instruction for Use, the VPS Stylet is able to detect the patient's physiological data, such as blood flow characteristics and ECG waveform.
From the point of insertion, patient data are sent to the VPS console for analysis. Using the highly advanced hardware and complex algorithm, the VPS console analyzes multiple vectors derived from these data and determines the location of the catheter tip while it is advanced through the patient's vasculature. Using the data gathered by the sensors and analysis done by the console, the VasoNova VPS console displays visual indicators. These indicators guide the clinician in real-time as the catheter is advanced through the vasculature:
The green arrow indicates the catheter tip is moving with the blood flow towards the heart, as appropriate.
The orange "do-not-enter" sign indicates the catheter is moving against blood flow, such as into the internal jugular vein and away from the heart, or has passed the lower third of the SVC and going into the right atrium.
The yellow triangle indicates there is not enough information available, which may occur if the catheter tip is against the vessel wall.
The blue bull's eye indicates the tip has arrived in the lower 1/3 of the SVC or at the caval-atrial junction.
Product page: VasoNova VPS...
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