SynCardia denies competitor ’ s market exit claim

SynCardia Systems isn’t exiting the market quite yet, according to a press release posted today in response to a competitor’s claim. Syncardia makes an artificial heart system designed to replace the functions of both the left and right ventricles and all 4 heart valves. “SynCardia’s machine works quite well. But it’s a very old machine with a big air compressor … I’m not surprised that they’re heading out of the market,” said artificial heart developer Carmat’s chief exec Marcello Conviti, according to an article on Seeking Alpha. The company said that it will “emerge from Chapter 11 reorganization” with a new owner, Sindex, on September 16, and went on to contest each point in Conviti’s statement. Syncardia touted the functionality of the device, saying its products account for 1,625 of the total 1,688 artificial hearts that have been implanted since 1969, and said that statistics from an International Society for Heart and Lung Transplantation indicated that 73.5% of patients implanted with the device were either alive or transplanted with a new heart at 6-months, and touted it as the “highest bridge to transplant rate of any durable device.” The company touted upgrades to its air compressor, saying it has received clearance from the FDA, CE Mark approval in the European Union and Health Canada approval for upgrades to the heart, including new drivers and portable drivers, over the l...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Business/Financial News Cardiac Implants Cardiovascular SynCardia Source Type: news

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Boston Scientific (NYSE:BSX) today claimed a win in an ongoing patent spat with Edwards Lifesciences (NYSE:EW) over transcatheter aortic valve replacement system patents. Marlborough, Mass.-based Boston Scientific said that a jury in the U.S. District Court for the District of Delaware ruled in its favor, finding that their ‘608 patent, related to a transcatheter heart valve sealing skirt, is valid and that Irvine, Calif.-based Edwards Sapien 3 aortic valve infringes on that patent. The jury determined that Edwards owes Boston Scientific $35 million in infringement damages through to the end of 2016. D...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiovascular Featured Legal News Patent Infringement Replacement Heart Valves Boston Scientific Edwards Lifesciences Source Type: news
Abiomed (NSDQ:ABMD) plans to invest $15 million in Shockwave Medical and collaborate on a training and education program in the U.S. and Germany, according to a newly-inked deal between the two companies. Shockwave’s intravascular lithotripsy technology uses sonic pressure waves to crack vascular calcium in the vessel wall, allowing arteries to expand under low pressure. The company said its catheter is often used in patients with heavily calcified Iliac arteries in order to prepare for the delivery of devices with catheters, like transcatheter heart valves and Abiomed’s Impella heart pump. “While we...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiovascular Featured Funding Roundup Wall Street Beat Abiomed Shockwave Medical Source Type: news
Researchers from Harvard University have developed a 3D printing technique...Read more on AuntMinnie.comRelated Reading: 3D-printed aortas could work well for TAVR 'Bitmap' technique enhances quality, speed of 3D printing 3D printing bolsters care for congenital heart disease Flexible 3D-printed heart replicates size, texture Rotational angiography is viable for 3D-printed hearts
Source: AuntMinnie.com Headlines - Category: Radiology Source Type: news
Up to 400 patients each year are set to benefit from the procedure being made available more widely.
Source: NHS Networks - Category: UK Health Source Type: news
(Wyss Institute for Biologically Inspired Engineering at Harvard) Researchers at the Wyss Institute have created a novel 3D printing workflow that allows cardiologists to evaluate how different valve sizes will interact with each patient's unique anatomy, before the medical procedure is actually performed. This protocol uses CT scan data to produce physical models of individual patients' aortic valves, in addition to a 'sizer' device to determine the perfect replacement valve size.
Source: EurekAlert! - Medicine and Health - Category: International Medicine & Public Health Source Type: news
Authors: Akbayrak H, Çiçek ÖF, Orhan A Abstract A mechanical heart valve thrombosis during pregnancy is one of the most lethal conditions to experience due to its detrimental effects on both mother and fetus. Cardiac surgery during pregnancy is reserved for cases where medical treatment fails due to harmful maternal and fetal effects. A 24-year-old female in the 38th week of pregnancy was admitted to the emergency room with aggravated dyspnea, tachypnea, and palpitations. She had 2 previous cardiac operations in her medical history. A stuck mechanical valve was diagnosed in the mitral position&nb...
Source: Saudi Medical Journal - Category: Middle East Health Tags: Saudi Med J Source Type: research
Authors: Solomonica A, Choudhury T, Bagur R Abstract INTRODUCTION: Transcatheter aortic valve implantation (TAVI) has become the standard of care for patients with severe symptomatic aortic stenosis at moderate to high surgical risk. Newer devices are now available and broader indications are expected in the near future. Areas Covered: The Placement of Aortic Transcatheter Valves (PARTNER) trials initially proved the efficacy of TAVI with the Edwards SAPIEN balloon-expandable valve in patients deemed in-operable and at high-risk and later on in intermediate-risk patients using the SAPIEN-XT valve. These trials had ...
Source: Expert Review of Medical Devices - Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research
Meril Life Sciences’ MyVal TAVR device Indian medtech maker Meril Life Sciences has won regulatory approval for a transcatheter aortic valve replacement (TAVR) developed exclusively in India, according to a published report. The MyVal device is balloon-expandable and employs a hybrid honeycomb cell design. The upper, open cells were designed to ensure un-jailing of coronary ostia, and the closed, lower cells offer high radial strength, according to the company’s website. India’s Central Drugs Standard Control Organisation granted the MyVal device approval for commercialization last month, according to a r...
Source: Mass Device - Category: Medical Devices Authors: Tags: Blog Business/Financial News Cardiac Implants Cardiovascular Regulatory/Compliance Replacement Heart Valves Central DrugsĀ  Standard Control Organisation Meril Life Science Source Type: news
Conclusions: Aortic regurgitation remains a challenging pathology for TAVR. TAVR is a feasible and reasonable option for carefully selected patients with pure aortic regurgitation.Cardiology 2018;141:132 –140
Source: Cardiology - Category: Cardiology Source Type: research
JenaValve has won a nod from FDA for expanded IDE enrollment of its transcatheter aortic valve replacement (TAVR) system. The agency’s nod is aimed at feasibility studies for the JenaValve Pericardial TAVR System with the Everdur transcatheter heart valve and expands eligible enrollment from 20 patients to 80 at high or extreme surgical risk. The Irvine, CA-based company said the prospective IDE studies are part of a larger, ongoing CE Mark clinical program investigating the JenaValve Pericardial TAVR System for the same indications at centers of excellence in Europe and New Zealand. Approval for addition...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Source Type: news
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