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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Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO
Source: Medical Device Recalls - Category: Medical Devices Source Type: alerts
Patients with pure native aortic valve regurgitation (NAVR) and increased surgical risk are often denied surgery. This retrospective study aimed to evaluate the “off-label” use of transcatheter heart valves (THV) for the treatment of NAVR. A total of 254 high surgical risk patients with NAVR (age 74 ± 12 years, Society of Thoracic Surgeons risk score 6.6 ± 6.2%) underwent transcatheter aortic valve implantation (TAVI) with early generation (43%) or ne wer generation (57%) devices at 46 different sites.
Source: The American Journal of Cardiology - Category: Cardiology Authors: Source Type: research
Xenotransplantation, EarlyView.
Source: Xenotransplantation - Category: Transplant Surgery Authors: Source Type: research
JenaValve Technology said this week it launched a new study of its next-generation pericardial transcatheter aortic valve replacement systems using its Coronatix transfemoral delivery catheter. In the newly launched trial, the Irvine, Calif.-based company will explore the use of the system as a treatment for severe aortic regurgitation in patients who are at high risk for conventional surgical valve replacement. “There is currently no TAVR treatment for severe aortic regurgitation cleared by regulators. These patients do not typically develop calcification at the implant site, so other TAVR valves that rely on t...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiovascular Catheters Clinical Trials Replacement Heart Valves JenaValve Source Type: news
Low-dose warfarin plus aspirin was associated with less bleeding without increasing thromboembolic events compared with standard-dose warfarin after aortic valve replacement with the On-X mechanical valve.Medscape Medical News
Source: Medscape Medical News Headlines - Category: Consumer Health News Tags: Neurology & Neurosurgery News Source Type: news
At this week’s Computer Assisted Radiology and Surgery conference (CARS 2018) in Berlin, scientists from the Fraunhofer Institute for Medical Image Computing in Germany will be showing off their unique software that helps to fix cardiac va...
Source: Medgadget - Category: Medical Devices Authors: Tags: Cardiac Surgery Cardiology Radiology Source Type: blogs
The underwriter of an initial public offering by Hancock Jaffe Laboratories (NSDQ:HJLI) this week exercised in full its over-allotment option, taking the gross proceeds from the flotation to nearly $9 million. The IPO, which priced on the last day of May, initially brought in $7.5 million for Irvine, Calif.-based Hancock Jaffe, which makes bioprosthetic implants designed to treat chronic deep vein insufficiency, heart valve conditions and coronary artery bypass grafts. The shares trade on the NASDAQ exchange under the symbol “HJLI.” Network 1 Financial Securities, the offering’s managi...
Source: Mass Device - Category: Medical Devices Authors: Tags: Funding Roundup Initial Public Offering (IPO) Vascular Wall Street Beat hancockjaffelabs Source Type: news
LivaNova (NSDQ:LIVN) said today it won FDA 510(k) clearance for its Memo 4D semi-rigid mitral annuloplasty ring, and said that the device has been used in its first commercial procedure. The Memo 4D mitral annuloplasty ring is a next-generation device designed for treating patients with mitral regurgitation, and is available in sizes from 24 mm to 42 mm, the London-based company said. “Memo 4D simplifies and standardizes degenerative complex mitral valve repair, facilitates minimally invasive surgical approaches and preserves the mobility of the mitral valve leaflets. The new larger sizes allow us to treat more ...
Source: Mass Device - Category: Medical Devices Authors: Tags: 510(k) Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance LivaNova Source Type: news
Condition:   Aortic Stenosis Interventions:   Device: TAVR;   Other: Warfarin plus Aspirin;   Other: Aspirin Only Sponsor:   Medstar Health Research Institute Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
Chinese heart valve maker Venus Medtech said today it launched its Venus P-Valve self-expanding pulmonary valve implant in Canada, touting that the first procedures with the valve have been performed in the region. The Venus P-Valve was designed for percutaneous use in native right ventricular outflow tracts, the Hangzhou-baesd company said, and is intended for patients who wish to avoid sternotomy and cardiopulmonary bypasses associated with traditional valve replacement surgeries. The first procedures were performed on two patients who had previously been treated with surgical patch correction for tetralogy of ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Business/Financial News Cardiovascular Replacement Heart Valves Venus Medtech Source Type: news
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