Tuesday, June 23, 2009
Medtronic's New MRI Compatible Pacemaker Gets CE Mark
Medtronic just received European approval for the firm's Advisa DR MRI™ SureScan™ Pacing System, an implantable pacemaker that has demonstrated safety when worn while undergoing MRI scans. The Advisa has not received FDA approval and therefore is not yet available in the US.
The Advisa MRI SureScan pacing system is the most advanced pacing system from Medtronic and combines for the first time MRI SureScan with key features from Medtronic pacemakers and defibrillator systems: exclusives such as MVP® (Managed Ventricular Pacing), OptiVol® Fluid Status Monitoring, and Ventricular and Atrial Capture Management (VCM and ACM). MVP reduces right ventricular pacing by 99 percent2. In SAVE PACe, a previous trial of pacemaker patients published in The New England Journal of Medicine, use of Medtronic MVP or Search AV+ modes was proven to dramatically reduce unnecessary right ventricular pacing. This reduction was shown to reduce the development of persistent atrial fibrillation. Further, the 2008 ACC/AHA/HRS Device-Based Therapy Guidelines indicate there may be deleterious effects from even modest levels of ventricular pacing associated with alternative programming modes.VCM and ACM are intended to automatically adjust impulses for optimal stimulation of the heart’s chambers. The device also offers enhanced diagnostics to help assist physicians in the diagnosis of irregular heart rhythms, particularly atrial tachyarrhythmia (AT) / AF. Additionally, upon commercial release, the Advisa MRI SureScan pacing system will be available for remote follow-up via the Medtronic CareLink® Network.
Press release: Medtronic Receives CE Mark for Second-Generation MRI Pacemaker...
Flashbacks: Positive Results for Medtronic's MRI-Safe Pacemaker; Developing the Next Generation of DBS Devices; Medtronic Starts Study of MRI Compatible Pacemaker; Is It Now Safe to Send a Patient With a Pacemaker for an MRI Scan?
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Monday, June 22, 2009
Steerable Biopsy Needle Helps Target Difficult Sites
Another technology we discovered browsing through the press releases is a targeting biopsy needle developed especially for accessing lung tissue. The Seeker Steerable Biopsy Needle™ from PneumRX (Mountain View, California) provides 360° thumb control to help guide placement to the exact target spot in lung parenchyma, with a hope of avoiding the dreadful pneumothorax.
From the product page:
The Seeker Steerable Biopsy Needle™ allows you to make fine adjustments in intra-parenchymal needle trajectory using the joystick controlled stylet. This promotes increased targeting accuracy and decreases repetitive needle passes.The Seeker Steerable Biopsy Needle™ lumen features a large cross sectional area made possible by a thinner walled needle design. This offers the potential to collect more tissue, facilitating a more reliable diagnosis.
Video demonstrating the movement of the Seeker needle:
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Thursday, June 18, 2009
Artificial Heart Inspired by a Cockroach and Built like an Onion
Cockroaches have multi-chambered hearts shaped like tubes that are much more resistant to failure than human hearts. The chambers are organized sequentially, each one pushing blood into the next, until the ideal output pressure is reached in the last chamber. Thus a single chamber failure in a cockroach heart is not cataclysmic to the organ; It can continue beating, but with less efficiency.
A team of biomedical engineers out of the Indian Institute of Technology, Kharagpur (IITK), have developed a new artificial heart, modeled after this muti-chamber idea. But instead of shaping the heart as a tube, they've created the chambers in a series of concentric spheres like an onion. This should, if it works, make the artificial heart less prone to errors than current breed of failure-prone artificial hearts. Another great benefit is that the heart should be much less expensive than current models.
Along with his team of engineers, the heart's inventor, Sujoy Guha, stole the show at a recent IITK technology conference. According to Guha, the heart is ready for clinical trials.
From the Telegraph India:
The device… draws inspiration from the heart of a cockroach which has a fail-safe mechanism. A cockroach’s heart has as many as 13 chambers, unlike the four in a human heart. As a result, failure of a single chamber in the former does not become life threatening unlike in the latter, says Guha. Moreover, the pumping of blood in a cockroach’s heart happens in a staged manner, which reduces the build up of pressure, often experienced in the human heart.“The inventiveness of our work lies in recognising the merits of the cockroach’s heart and adapting them to the needs of the human system,” said Guha. Guha’s team, which has already tested the device on frogs, has recently sought permission to test it on goats. A patent application has also been filed for it.
“The technology is ready for clinical trials,” said Guha. “A series of diaphragms divides the load of the pump, thereby increasing its longevity,” he added. The internal flow is designed to prevent excessive blood recirculation, stagnation and mechanical trauma. An obvious advantage of such a device would be to lower the need for heart transplants. “With increased understanding of the heart’s functioning and continuing improvements in prosthetics, computer science, battery technology and fuel cells, a practical artificial heart may be a reality in the 21st century,” said Guha.
Link: An Indian artificial heart...
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Wednesday, June 17, 2009
St. Jude Medical's Cool Point Irrigation Pump Gets US OK
The FDA has just approved St. Jude Medical's new Cool Point™ Irrigation Pump for use with SJM's open-irrigated ablation catheters for radiofrequency (RF) ablation procedures for atrial fibrillation.
Designed to enhance physicians’ ability to perform successful atrial ablations, the new Cool Point irrigation pump was developed specifically for use with the company’s IBI-1500T9-CP cardiac ablation generator and family of Therapy™ Cool Path™ irrigated catheters.In addition to the intuitive setup and operation, the Cool Point Irrigation Pump provides monitoring and safety features, which are designed to give physicians more control over therapy delivery. This interface enables physicians to monitor the total volume of irrigation solution delivered through an easy-to-read display.
The pump’s proprietary tubing includes an in-line occlusion detector, which monitors flow pressure between the pump and the catheter tip, providing an alert if flow pressure increases substantially relative to the flow rate (an indication that irrigation ports on the catheter tip may be blocked and the tip cooling may not be effective). In addition, the pump has redundant bubble detectors, each designed to detect bubbles as small as two microliters. Bubbles in the bloodstream may lead to embolism or stroke.
Press release: St. Jude Medical Announces FDA Approval of the Cool Point Irrigation Pump...
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Tuesday, June 16, 2009
EU Issues OK for Minimally Invasive Subcutaneous Implantable Defibrillator
Cameron Health out of San Clemente, California has seen its Subcutaneous Implantable Defibrillator (S-ICD®) System trialed in hospitals around the world, the results of which netted the company approval for the device across the European Union. Unlike traditional AICDs, Cameron's device does not require pacer-defibrillator leads to be placed in the heart, and therefore may overcome the various problems related to lead implantation and retention.
Conventional ICD’s require placement of at least one lead in or on the heart. Most frequently, these leads, constructed of thin insulated wires, are threaded through a vein and then placed inside the heart. These conventional transvenous leads allow for sensing of the heart’s rhythm and delivery of a life saving electric shock when a harmful arrhythmia is detected. The surgical placement and residence of these transvenous leads within the patient’s heart are associated with a significant proportion of the complications related to this well established and highly effective therapy. In contrast, the Cameron Health S-ICD System resides just under the skin, potentially avoiding many of the complications associated with the conventional implant procedure and long term performance. The S-ICD System is also designed for ease of placement and removal while shortening the surgical procedure time. The S-ICD System is the first totally subcutaneous implantable defibrillator used to treat SCA. Market launch is scheduled to commence this summer in select geographies as Cameron Health ramps production.
Here's a link to the presentation given at this year's Heart Rhythm Society's Annual Scientific Session: Clinical Evaluation of the Subcutaneous Implantable Defibrillator (S-ICD®) System...
Link: Cameron Health homepage...
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Friday, June 12, 2009
St. Jude Medical Introduces New ICD-Leads Connector
St. Jude Medical is introducing a new connector system, called SJ4, designed to minimize the number of connections between cardiac leads and the company's AICDs. For now the new connector will be used only in Current® Plus AICD model, but our guess is that if accepted by surgeons, cardiologists and radiologists, the connector might be making its way into other company devices.
The SJ4 connector system features a single connection between the device and the defibrillation lead, and a single set screw (used to tighten and secure the lead to the device). Previous defibrillator lead designs required three separate connections and four set screws. The reduced number of lead connections also lessens the risk of lead-to-can abrasion, a known complication that can occur in patients who have an implantable device."With only a single connection and one set screw, the SJ4 connector has the potential to improve the implant procedure, may reduce the lead volume under the ICD in the chest wall and may improve patient comfort," said Cleveland Clinic's Bruce Wilkoff, M.D., who is on the company's physician lead review board and has sponsored research with St. Jude Medical, Inc. Dr. Wilkoff implanted the first Current Plus ICD with SJ4 connector on June 4, 2009. "This design is intended to reduce the risk of incorrect connections of the lead to the ICD and reduce procedure time."
The St. Jude Medical SJ4 connector system is designed to meet the draft IS-4 standard as set forth by the International Organization of Standardization (ISO) but will not be labeled as such until the standard is finalized, which is expected later this year. St. Jude Medical began launch of the SJ4 connector system after ISO-directed interchangeability testing among multiple manufacturers was completed. This testing was deemed an important step in ensuring that these new leads, which currently meet the drafted IS-4 standard, would be compatible with future implanted devices.
"Simplifying the lead connection process is one of many design features we have incorporated as part of our commitment to making procedures safer for patients and more efficient for physicians, from implant through follow-up," said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division. "This aligns with our strategy of reducing lead risks and increasing reliability, which includes technology designed to reduce lead-to-can abrasion and sensing of far-field ventricular signals in the atrium."
The Current Plus ICD was approved by the FDA in April 2009, along with the company's Promote(R) Plus cardiac resynchronization therapy defibrillator (CRT-D), which are compatible with the Durata(R) SJ4 defibrillation lead. As with previously announced leads in the Durata lead family, the Durata lead with SJ4 connector features a soft silicone tip and Optim(R) insulation, a hybrid insulation material that provides increased abrasion-resistance and durability, along with the flexibility and handling characteristics that facilitate device implantation.
Press release: St. Jude Medical Announces Initial Implant of First-to-Market Connector System in the U.S.
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Cook Launches Z-TRAK PLUS Introduction System for Zenith TX2 TAA
A small subset of our readers that are actually involved in endovascular aortic aneurysm repairs will be pleased to know that Cook Medical is releasing a new and improved introduction system for its Zenith TX2 TAA Endovascular Graft. The company says the new introducer, Z-TRAK PLUS, sports features that can improve "maneuverability for controllable device orientation and deployment."
The launch of the new introduction system comes as physicians are increasingly turning to thoracic endovascular repair (TEVAR) as the preferred, minimally invasive option for treating TAAs. TAAs occur when the section of the aorta that runs down the chest weakens and bulges outward like a balloon, often caused by a hardening of the arteries, high blood pressure, or trauma. Aneurysms of the thoracic aorta are potentially fatal, and open surgical repair is a highly invasive procedure many TAA patients cannot survive, making TEVAR their only treatment option. Untreated, five-year survival is estimated at between 10 to 15 percent.Cook's Zenith TX2 TAA Endovascular Graft, indicated for the treatment of descending TAA, is a tube of surgical graft material reinforced with self-expanding stainless steel Z-stents and an open stent with barbs designed to hold the device securely in place within the aorta after deployment. It is sized to the length of the thoracic aorta that needs to be covered to seal off the aneurysm. The graft is positioned in the aorta under the physician's image-guided control across the aneurysm to prevent blood flow into the aneurysm. Cook's Zenith TX2 is the only endograft with circumferentially anchoring barbs on both the proximal and distal segments of the device, which provides best-in-class fixation. Radial force from the self-expanding Z-stents enables the graft to provide an excellent seal within the patient's aorta.
Utilizing a hydrophilic-coated Cook Flexor sheath and super-elastic alloy inner cannula, Z-TRAK PLUS was designed to provide enhanced control and flexibility of entry and tracking. Cook's renowned Flexor sheath features kink-resistant tubing technology for superior flexibility and trackability during use. A semi-deployed tri-fold configuration prevents a 'wind-sock' effect during deployment, thus enabling the physician to avoid slowing or stopping of the heart.
Historically, open surgical repair has been the standard treatment for TAAs. Under this approach, the chest cavity is opened and the aorta is clamped, allowing the surgeon to sew a surgical graft into place to prevent a rupture. Surgical repairs may carry health risks for older patients as they likely suffer from other significant medical conditions.
TEVAR, a minimally invasive alternative to traditional, open surgery, involves an endograft guided into the body with a catheter to seal off the aneurysm from within. Patients undergoing TEVAR typically experience shorter recovery times and are also at a lower risk of the co-morbidities associated with open surgical repair. In particular, the Zenith TX2 device is inserted through a small incision in the groin to access the patient's femoral artery. The device is guided into position through the patient's arteries under fluoroscopy. The fabric-covered self-expanding stent-graft is then placed in the weakened section of the thoracic aorta to relieve pressure on the aneurysm to reduce the risk of rupture. For more information, visit
Press release: New Endograft Introduction System Enhances Physicial Control During Minimally Invasive Treatment for Thoracic Aortic Aneurysms
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Tuesday, June 9, 2009
World's Smallest TEE Probe Goes Multiplane
Philips is releasing a new multiplane transesophageal echocardiography (TEE) transducer that the company touts to be the world's smallest. Developed to make cardiac imaging better in pediatric population, the probe could also be of benefit to adults with esophageal strictures and other obstructive defects. The S8-3t microTEE transducer is part of Philips' iE33 echo system offerings, and is being presented this week at the 20th annual American Society of Echocardiography (ASE) in Washington, D.C.
Due to the larger size of previously available pediatric TEE transducers, small babies have been impossible to image during critical cardiac catheterization or surgical procedures. As a result, high-risk procedures have been done routinely on these tiny patients without transesophageal echocardiography images available to the interventionalist or surgeon."The microTEE probe is a major advance in our ability to provide intra-operative cardiac imaging in newborn babies and infants,” said Dr. Girish Shirali, M.D., director of pediatric echocardiography at Medical University of South Carolina (MUSC) Children’s Hospital. “We are delighted with the image quality, and the miniaturization of the probe has already proven invaluable to our pediatric interventionalists in high-risk cath lab procedures. Finally, our smallest and sickest patients can be imaged intra-operatively just like everyone else.”
Building on Philips’ existing 2D technology, the microTEE transducer is roughly one-third the size of previous pediatric TEE transducers, allowing physicians to ‘turn on the lights’ for the first time for their tinier patients and providing the images they need during interventional procedures. Available globally in summer 2009, the new microTEE is also entering trials for adult patients requiring TEE imaging but who have difficulty tolerating standard TEE probes.
Press release: Philips announces world's smallest multiplane transesophageal transducer
Product page: iE33 Echocardiography System
Bottom image: This ventricular septal defect on a 5.4 kg infant is viewed side-by-side in 2D and color flow Doppler modes available on the Philips microTEE transducer.
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Thursday, May 21, 2009
Edwards Touts Results of SAPIEN Valve Study
Yesterday at EuroPCR 2009 in Barcelona, Edwards Lifesciences presented results of a clinical study evaluating the company's SAPIEN transcatheter cardiac valve replacement system. In the study, the valve system was implanted using both transfemoral and transapical approaches.
The data showed a 30-day survival rate of 93.7 percent in transfemoral procedures (valve delivered via the femoral artery), and 89.7 percent in transapical procedures (valve delivered via a small incision between the ribs) -- rates that were better than the predicted surgical survival in this high-risk patient cohort. Implant procedure safety with the Edwards SAPIEN valve was strongly demonstrated with low incidences of valve malposition (1.5 percent), coronary obstruction (0.6 percent), stroke (2.5 percent), conversion to surgery (2.7 percent), need for permanent pacemaker (7 percent), and significant aortic regurgitation (4.7 percent).Also presented today was the first complete six-month data set of the 130 patients enrolled in the PARTNER EU clinical trial. The data demonstrated strong hemodynamics and valve performance through measurements including effective orifice area and ejection fraction, as well as 100 percent freedom from structural valve deterioration. PARTNER EU was designed to evaluate the Edwards SAPIEN valve in a setting where, for the first time, an interventional cardiologist and cardiac surgeon partnered to screen and determine the correct treatment approach for each patient.
Press release: Edwards Lifesciences Reports Positive Data From Its Largest Transcatheter Valve Implant Series
Device info page: Edwards SAPIEN Transcatheter Heart Valve
Flashbacks: Medtronic's CoreValve Transcatheter Aortic Valve Replacement System Performs Well in Trial; SAPIEN Transcatheter Cardiac Valve Trial Going Ahead; Edwards Trials Company's Minimally-Invasive Pulmonic Valve; Edwards Sapien Transcatheter Aortic Valve Makes Human Debut
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Wednesday, May 20, 2009
Medtronic's CoreValve Transcatheter Aortic Valve Replacement System Performs Well in Trial
Medtronic today presented findings from a European trial testing the effectiveness of the CoreValve ReValving system, a percutaneous aortic stenosis repair device, in a subclavian approach for people who were at risk if the femoral approach would have been used. Medtronic has acquired the Irvine, California based CoreValve, Inc. in March of this year, and is now moving full steam ahead to implement this nitinol-based stent device for clinical settings.
The data reported procedural success of 100 percent; 24-hour survival of 100 percent; and 30-day survival of 89 percent. The available 30-day analysis also demonstrated clinical improvement in heart failure symptoms with 76 percent of the patients gaining at least a one-stage NYHA class and one-third improving by at least two stages.
Medtronic’s market-leading CoreValve system was designed to allow the implant of a replacement heart valve in patients with aortic stenosis who are at high or prohibitive surgical risk. The system enables a catheter-based implant via a peripheral blood vessel, traditionally the femoral artery. A significant subset of patients, however, have compromised peripheral arteries, which prevents the use of the femoral approach. Uniquely, the delivery system of the CoreValve device is small enough to allow an alternative approach via the subclavian artery beneath the collar bone.
The data presented today at the PCR interventional cardiology meeting in Barcelona reported on data from 74 patients for whom subclavian access was used within the CoreValve Extended Evaluation Registry, an observational study which closed in January 2009. The average age of the patients was 81.4. Moreover, the average Logistic EuroSCORE (a measure which predicts risk of procedural mortality based upon patient status) was notably high at 28.4%.
Press release: Medtronic's CoreValve Shows Subclavian Access Success in Patients Contraindicated for Femoral Approach
Product page: CoreValve ReValving...
Animation below the fold demonstrating the implantation of the CoreValve:
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Thursday, May 14, 2009
Positive Results for Medtronic's MRI-Safe Pacemaker
A clinical study evaluating the performance of Medtronic's EnRhythm MRI SureScan pacemaker has shown that the device is not subject to interference from magnetic resonance imaging. As the only pacemaker approved for MRI in the EU, the news may give the FDA enough guidance to also approve it as the first of its kind in the US.
Results showed that Medtronic's investigational EnRhythm MRI SureScan pacing system still performs as intended during and after an MRI when used according to the product's labeling. The data showed no MRI-related complications, and no arrhythmias, or asystole (absence of electrical activity in the heart) during MRI scans.This prospective, randomized, controlled trial involved 464 individuals successfully implanted at 41 centers in the U.S., Canada, Europe and the Middle East. After successful implant of pacemaker and leads, 258 patients were randomized to MRI and 206 to no MRI (control). All patients were evaluated before and after the scan, and one week and one month after MRI scan/control visit. There was no difference in performance between the MRI group and the control group.
Press release: Medtronic Demonstrates Positive Results on First Pacemaker Designed for Use with MRI
Flashback: Medtronic Starts Study of MRI Compatible Pacemaker
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Digital Subtraction Angiography on a Single Image
Analyzing angiography sequences typically requires viewing a series of black and white images and noticing the differences the contrast medium created as it passed through the obstructions in the vessels. To help with visualization and to improve diagnosis, Siemens is releasing a new digital subtraction angiography (DSA) software, the syngo iFlow, that automates the process to produce a color image highlighting the path of the contrast medium.
From a Siemens press statement:
The syngo iFlow application, for example, can be used to enhance pre-procedural and post-procedural imaging of patients under treatment for leg stenosis. Flow deviations and the increased utilization of collaterals can more easily be detected prior to intervention, since anomalies more readily attract the physician's attention due to their specific colors. Following the intervention, the success of a balloon dilatation or stent implantation of a stenosis is readily visible due to the improved flow.In order to obtain a color image, syngo iFlow takes the time to maximum opacification of each individual pixel, starting with the injection and subsequently visualizing the distribution of the contrast medium through the vessels. These time measurements are then represented by a color allowing visualization of the complete vessel tree in one image.
Press release: Siemens sets a new standard in subtraction angiography
Product brochure: syngo iFlow (PDF)
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Monday, May 11, 2009
SJM Gets FDA OK for New AICDs
St. Jude Medical is reporting that it has received FDA approval for two of the company's latest cardiac defibrillators, the Promote Plus cardiac resynchronization therapy defibrillator and Current Plus implantable cardioverter defibrillator. Both models have wireless reporting capabilities and SJM says they should prove to be more comfortable for the patients.
From the press release:
To better assist physicians in accurately diagnosing and managing patients with fast rates in the heart’s upper chambers (atria), the Promote Plus CRT-D and Current Plus ICDs also include a new atrial tachycardia/atrial fibrillation (AT/AF) Alert feature. This feature is designed to notify physicians when a rapid atrial rate exceeds a programmed value and occurs over an extended time period. These devices can also be programmed to notify the patient through a unique vibratory alert that has been clinically proven more effective than audible alerts.1 Additionally, the devices have the ability to inform the patient’s clinic through the St. Jude Medical Merlin@home® transmitter and Merlin.net™ Patient Care Network (PCN). These features allow the physician to better manage patients’ atrial arrhythmias, such as AF.The Promote Plus CRT-D and Current Plus ICDs are built on the St. Jude Medical consolidated hardware and software “Unity” device platform and include the company’s advanced safety features and algorithms for better patient management. These include improved lead monitoring capabilities – including daily checks of all pacing and shock configurations – that provide added patient safety.
TailoredTherapy features in these devices include:
* QuickOpt® timing cycle optimization - a programmer-based optimization method that is proprietary to St. Jude Medical that is used with CRT-Ds, CRT-Ps (cardiac resynchronization therapy pacemakers) and ICDs to help physicians quickly program the device's timing cycles – in about 90 seconds - to help deliver optimal therapy to patients
* DeFT Response® technology - designed to help devices meet the needs of patients with high or varying defibrillation thresholds, helping physicians to ensure appropriate delivery of life-saving therapy
* VIP® (Ventricular Intrinsic Preference) algorithm - provides a delay in device stimulation of the lower chambers of the heart (ventricles) to allow the patient's own heart rhythm to prevail when possible. The VIP technology is designed to provide device stimulation only when needed, which has been shown to be better for patients' overall heart health.
* SenseAbility® technology - designed to enable physicians to program the device to more accurately sense abnormal heart rhythms, thereby protecting the patient from receiving inappropriate shocks
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Edwards Announces New Cardiac Offerings
Edwards Lifesciences won FDA approval for its new Carpentier-Edwards PERIMOUNT Magna Ease aortic valve, and is also introducing the PORT ACCESS EndoDirect surgery system for minimally invasive cardiac procedures.
Features of the Magna Ease valve from Edwards' EU product page:
Low profile facilitates insertion and provides sinotubular junction clearance Low cusp height maximizes coronary ostia clearance Suture markers aid in valve orientation and suture placement Scalloped and compliant sewing ring provides an optimal anatomic fit Compact sewing ring maximizes valve orifice area Industry-leading effective orifice areas (EOAs) and low gradients documented in multiple published studies Magna Ease heart valves include leaflets treated with the Carpentier-Edwards ThermaFix process*—the only dual-action tissue treatment designed to confront both major calcium binding sites Built on the proven performance of PERIMOUNT aortic valves, with durability up to 20 years
About the PORT ACCESS EndoDirect System from the press release:
Edwards is introducing the PORT ACCESS EndoDirect System, which allows cardiac surgeons to stop a patient's heart and keep it at rest for the duration of the heart valve procedure without an incision down the middle of the chest. In procedures such as mitral valve repair and replacement, the EndoDirect System provides a minimally invasive alternative for direct aortic cannulation when femoral access (groin cannulation) is not an option.
Company animation describing the Magna Ease and comparing it to the Magna model:
Link to video of the Magna Ease implantation performed at the University Hospital of Wales...
Press release: Edwards Lifesciences Receives FDA Approval for New Heart Valve
Edwards EU product page: PERIMOUNT Magna Ease Aortic Heart Valve
Flashback: Edwards PERIMOUNT Magna Mitral Valve Gets FDA's Green Light
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SJM Gets US Green Light for Adjustable Annuloplasty Ring
The FDA has given St. Jude Medical approval for the Attune Flexible Adjustable Annuloplasty Ring. Indicated for patients with mitral regurg, the product's unique adjustable design should let the surgeon perform a tighter, more precise fitting.
From the press release:
Unlike most other flexible annuloplasty rings that have a fixed size, the Attune ring can be adjusted after it is sutured to the annulus -- a feature that allows physicians greater control in altering its size and shape to contribute to a more refined repair specific to fit each patient's heart valve anatomy. The Attune ring is suitable for repairs performed with open chest, minimally invasive or robotic surgical approaches.The ring's flexibility allows the annulus to continue its natural movement as the valve opens and closes, thus contributing to more physiologic valve function. The ability to adjust the ring post-implant promotes ideal leaflet alignment to reduce or eliminate residual regurgitation, or small leaks after the repair.
Press release: St. Jude Medical Announces FDA Clearance and Launch of the Attune Annuloplasty Ring for Heart Valve Repair
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Friday, May 8, 2009
Minimally Invasive Aortic Valve Replacement With the Lotus System
Sadra Medical out of Campbell, California just won $30 million in financing to move forward the company's system for transcatheter replacement of aortic valves. Currently under a feasibility study in Europe, the Lotus device has already been used successfully on a 93 year old patient in Germany.
The Lotus™ Valve System is the first fully repositionable technology designed to specifically address both the disease etiology of the aortic valve and the unique requirements of a transcatheter aortic valve replacement procedure. In addition to its repositioning and self-centering features which facilitate optimal positioning of the valve, the device's unique ability to be resheathed and retrieved provides physicians with more control over the procedure.The Lotus™ Valve System consists of the Lotus™ Valve, a bovine tissue tri-leaflet bioprosthetic aortic valve supported by a self-expanding nitinol stent structure, and the Lotus™ Delivery Catheter, a delivery system for guidance and placement of the Lotus Valve. The device is introduced endovascularly via the femoral artery using conventional catheterization techniques. The Lotus™ Delivery Catheter balances flexibility and support to facilitate smooth tracking through potentially challenging diseased anatomy and it is easily guided into the aortic root using a retrograde approach. The valve is intended for placement in the aortic annulus overlying the native aortic valve. The system is engineered to enable placement in a beating heart, and the valve begins to function early in the release process, minimizing systolic ejection forces.
The Lotus™ Valve does not require balloon inflation or rapid pacing of heart. The fine operator control over valve unsheathing, seating and deployment is an essential feature that aids in precision placement and helps the operator to avoid coronary obstruction and minimize contact with the mitral valve. Further, this comprehensive control of the valve until deployment provides confidence in achieving a first-time fit. Prior to releasing the Lotus Valve into its final position, the valve may be retracted into the sheath of the delivery system for repositioning and redeployment or removal if it cannot be satisfactorily positioned. The Lotus Valve features the Adaptive™ Seal, which is designed to conform to irregular surfaces of the native anatomy to minimize perivalvular leakage.
Here's an animation demonstrating the Lotus system:
Product page: Lotus™ Valve System ...
Press release: Sadra Medical Raises $30 Million Will Take Next-generation Percutaneous Aortic Valve Replacement System to Commercial Viability ...
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Thursday, May 7, 2009
NASA Super Plastic in Medtronic CRT
Medtronic won FDA approval, and is consequently making available, the Attain Ability® left-heart lead (Model 4196) for use with cardiac resynchronization devices. The lead is composed of an advanced aerospace resin, named Langley Research Center's Soluble Imide, or LaRC-SI, and is the first time material developed by NASA has been used in implantable medical devices.
From the Langley Research Center:
LaRC-SI is a wholly aromatic high-performance thermoplastic polyimide that is a selfbonding/non-curing resin made from commercially available monomers. This polyimide has superior mechanical, electrical, and adhesive properties and an extensive range of processing choices that allow it to serve as either a dielectric inner layer, substrate coating, or the substrate. LaRC-SI film is made by casting or spraying a solution consisting of xylene, N-methyl-pyrrolidinone (NMP), and LaRC-SI powder. At different drying temperatures, various amounts of solvent are removed to the point where it becomes insoluble but retains its melt processability. LaRC-SI excels in the following characteristics:
Solubility in conventional high-boiling solvents Melt flow and bonding properties Electrical properties -- low dissipation factor and high dielectric strength Resistance to harsh environments such as radiation, cryogenic and elevated temperatures, most fluids, corrosives, and biological inertness It is highly flexible, resistant to chemicals, and withstands extreme hot and cold temperatures. The "super plastic" was determined to be biologically inert, making it suitable for medical use, including implantable devices.
Medtronic states that the Attain Ability™ lead wire one of the thinnest left-heart AICD leads available and this affords the ability to choose between different sites on the endocardium to deliver the lead for optimal therapy.
Here's a Medtronic animation showing the placement of the device:
Press release: FDA Approves New Medtronic Left Heart Lead for Cardiac Resynchronization Therapy Devices ...
NASA : Polymer Coats Leads on Implantable Medical Device...
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Monday, May 4, 2009
Magnus Operating Table from Maquet
MAQUET has just unveiled improvements to its Magnus operating table, a system that can position the patient into virtually any surgical position, and at the same time accommodate patients weighing up to 250 kilograms.
From the press release:
An optimum exposure area is achieved in combination with gravitational force and the operating table's extreme tilting and tipping functionality. The tilt angle of up to 80º and canting angle of up to 45º combined with the system's fully compatible modules open up virtually unlimited positioning possibilities. "This way a patient weighing up to 250 kilograms can be brought into any possible position. MAGNUS is thus fast approaching its vision of the "floating" patient," so Dr. Engel.This is of particular significance when it comes to minimally invasive surgery, as it is the table's extreme tilting and tipping function that makes surgical interventions even possible on an obese patient.
With its unique height adjustment range varying between 535 mm (21 Inch) and 1235 mm (49 Inch), the MAGNUS ensures ergonomic and thus relaxed working conditions even during longer operations. The benefits of individual settings are particularly evident during laparoscopic interventions: As the MAGNUS can be lowered further than any other table the surgeon can keep his elbows positioned comfortably at his side and is not forced to revert to a tiring position. The table's unique lowering functionality makes the commonly used step stool to decrease the distance to the surgical field a thing of the past. The larger abdomens of obese patients can be operated on the MAGNUS while maintaining a relaxed and comfortable posture. In contrast to laparoscopic operations, a high table position is required for hip replacement in the dorsal position. This way, the operation which may take up to 90 minutes can be performed in an upright position. If the table cannot be adjusted to the height required, the surgeon is forced to assume a bent over posture which generally results in tension and fatigue.
Besides its settings designed to cater to various indications, the MAGNUS can optimally adjust to the height of the surgeon. The advantage of this comes to the fore when putting the table in an international context: Whereas the height of the average male in Sweden is 181.5 cm (71,4 Inch), the average male in the Philippines is less than 164 cm (64,5 Inch).
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Monday, April 27, 2009
FDA OK'es Impella 5.0 and Impella LD Circulatory Assist Devices
Abiomed, Inc. is reporting that the FDA has issued 510(k) clearance for the company's Impella® 5.0 and Impella® LD Circulatory Support Devices. The Impella® 5.0 is shown above, and Impella® LD is in the lower picture. As we have said before, the big trick is for the company to convince cardiologists and cardiac surgeons that its devices are better, and maybe even safer, than commonly used Intra Aortic Baloon Pumps (IABPs). We, of course, have been following the Impella system for many years now, ever since it was a German invention.
More from the announcement by the company:
Similar to the Impella 2.5, which received 510(k) clearance on June 2, 2008 for partial circulatory support for periods of up to six hours, the Impella 5.0 and Impella LD devices are minimally invasive catheter-based pumps, designed to provide temporary circulatory support and reduce the workload of the heart muscle. The pump is approximately the size of a pencil with a small nine French catheter, which drives up to five liters of blood flow per minute, a flow rate typically adequate to fully support the average adult.
“Formerly, only patients with a grave prognosis received aggressive circulatory support due to the invasiveness and potential complications associated with conventional surgery devices,” said Anson Cheung, M.D., Surgical Director of Heart Transplantation at St. Paul’s Hospital in Vancouver, British Columbia. “The availability of the Impella 5.0 and Impella LD has reduced our threshold to implanting patients with a temporary circulatory support device and offers a potential benefit to reduce the likelihood of escalating therapy, such as implantable devices or heart transplantation. We have already seen patient success from Impella 5.0 and LD in providing the therapeutic benefit of ventricular unloading, which helps to interrupt the progression of heart muscle damage and potentially repair reversible damage.”
The Impella 5.0 further enhances Abiomed’s heart recovery portfolio, providing cardiologists and surgeons with the clinical flexibility to select and deploy circulatory support devices for patients based on the severity of cardiac dysfunction, the amount of flow needed while addressing the dysfunction, and the preferred implant approach. In application, Impella is intended to increase the flow delivered by the heart, which can potentially reduce the work of the heart and augment coronary flow.
“Now, both cardiologists and surgeons can use the minimally invasive Impella 5.0 and Impella LD devices for critical patients whose conditions require high-flow circulatory support,” said Michael R. Minogue, Chairman, President and Chief Executive Officer of Abiomed. “This FDA clearance represents Abiomed’s ability to create new heart support technologies and execute on the regulatory path. This is the eighth FDA regulatory clearance or approval in the past four years.”
Press release: Abiomed Receives FDA 510(k) Clearance for Impella(R) 5.0 and Impella(R) LD...
Product page @ Abiomed: Impella...
Flashbacks: Impella 2.5 Heart Pump Given Green Light in US; Impella 2.5 Heart Pump Performs Well in a Feasibility Trial ; Impella Percutaneous VAD to be Studied for Acute MI Patients; impella® recover LV; Impella Recover Devices Approved in Germany for Reimbursement
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