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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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Emboline said today that it pulled in a $10 million Series B round for the namesake embolic protector it’s developing for heart valve replacement procedures. The Emboliner catheter is designed to prevent blood clots from passing into the cerebral vasculature during transcatheter aortic valve replacements. Santa Cruz, Calif.-based Emboline said the round includes $3 million from a consortium led by SV Tech Ventures and Shangbay Capital and $7 million in already-issued convertible notes. The cash is earmarked for Emboline’s SafePass clinical trial, submission for CE Mark approval and initial commerciali...
Source: Mass Device - Category: Medical Devices Authors: Tags: Funding Roundup Replacement Heart Valves Vascular Wall Street Beat Emboline Source Type: news
Authors: Amri A, Laroche G, Chakfe N, Heim F Abstract With over 150,000 implantations performed over the world, transcatheter aortic valve replacement (TAVR) has become a surgical technique, which largely competes with open surgery valve replacement for an increasing number of patients. The success of the procedure favors the research toward synthetic valve leaflet materials as an alternative to biological tissues, whose durability remains unknown. In particular, fibrous constructions have recently proven to be durable in vivo over a 6-month period of time in animal sheep models. Exaggerated fibrotic tissue formati...
Source: Biomedizinische Technik/Biomedical Engineering - Category: Biomedical Engineering Tags: Biomed Tech (Berl) Source Type: research
Conclusions -In both study designs, we did not observe a clinically larger risk for IE in the short periods after IDTs. We also found no association between IDTs and IE among high-risk patients. Therefore, antibiotic prophylaxis for prevention of IE is not required for the Taiwanese population. PMID: 29674326 [PubMed - as supplied by publisher]
Source: Circulation - Category: Cardiology Authors: Tags: Circulation Source Type: research
AbstractThe governing international standard for the development of prosthetic heart valves is International Organization for Standardization (ISO) 5840. This standard requires the assessment of the thrombus potential of transcatheter heart valve substitutes using an integrated thrombus evaluation. Besides experimental flow field assessment andex vivo flow testing, computational fluid dynamics is a critical component of this integrated approach. This position paper is intended to provide and discuss best practices for the setup of a computational model, numerical solving, post-processing, data evaluation and reporting, as ...
Source: Cardiovascular Engineering and Technology - Category: Cardiology Source Type: research
Centers for Disease Control and Prevention Director Robert Redfield has resigned from positions at four groups, including a gene therapy biotechnology company and a conservative AIDS organization, to comply with government ethics rules, according to his financial disclosures. Redfield, a longtime HIV/AIDS researcher who started the job March 26, succeeded Brenda Fitzgerald, the former Georgia […]Related:These are the top priorities for the nation’s top cancer doctorFor advanced lung cancer, immune therapy plus chemo prolongs survivalThis 3-year-old has ‘a sparkle’ in her heart: The world’s sm...
Source: Washington Post: To Your Health - Category: Consumer Health News Source Type: news
Boston Scientific (NYSE:BSX) said today that the European Patent Office revoked a patent owned by Edwards Lifesciences (NYSE:EW) in the latest round of their ongoing spat over transcatheter aortic valve replacements. In March 2017 a German court issued a mixed decision in the international battle over transcatheter aortic valve replacement patents between the two companies, less than a week after a U.K. patent court handed down a similar decision. Yesterday Boston said it’s confident that the new EPO decision “will have a positive impact on both suits.” Meanwhile the U.K. Hig...
Source: Mass Device - Category: Medical Devices Authors: Tags: Legal News Patent Infringement Replacement Heart Valves Boston Scientific Edwards Lifesciences Source Type: news
Publication date: Available online 16 April 2018 Source:Journal of Cardiology Cases Author(s): Shiro Miura, Katsumi Inoue, Satoshi Yamada, Takehiro Yamashita, Kenji Ando Unicuspid aortic valve (UAV) is an extremely rare congenital heart valve abnormality while bicuspid valve (BAV) has been reported as one of the most common cardiac anomalies. With a UAV usually showing similar presentations to a BAV, such as aortic regurgitation or aortic stenosis (AS), it is challenging to differentiate them from each other in clinical settings. Despite some features shared between both valve disorders, there can be a clinical significan...
Source: Journal of Cardiology Cases - Category: Cardiology Source Type: research
loy C PMID: 29674156 [PubMed - as supplied by publisher]
Source: Archives of Cardiovascular Diseases - Category: Cardiology Authors: Tags: Arch Cardiovasc Dis Source Type: research
PMID: 29652422 [PubMed - in process]
Source: Kardiologia Polska - Category: Cardiology Authors: Tags: Kardiol Pol Source Type: research
CONCLUSIONS: Decellularized heart valves could be the new material used as artificial heart valves. Pulmonary allografts derived from the hearts of heart transplant recipients are considered to be useful material for decellularized heart valves. The application of this valve to Japanese clinical circumstances and using the hearts of heart transplant recipients is considered to be very significant. PMID: 29657239 [PubMed - as supplied by publisher]
Source: Circulation Journal - Category: Cardiology Authors: Tags: Circ J Source Type: research
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