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FDA warns of high stroke, mortality risk with SynCardia TAH-t C2 controller
The FDA on Friday released a letter warning of a higher mortality risk and stroke rate than expected for patients receiving treatment from SynCardia Systems’ Temporary Total Artificial Heart Companion 2 Driver System. Data indicating the higher mortality and stroke rate came from a post-approval study conducted by the company itself, the FDA said. The study indicated that patients treated with the previous generation driver of the device, the Circulatory Support System Console, experienced a lower rate of stroke and mortality compared with the C2. The TAH-t system is designed to function as a bridge to a heart transplant...
Source: Mass Device - August 20, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Food & Drug Administration (FDA) SynCardia Source Type: news

ACC 2019: Medtronic, Edwards low-risk TAVR trial data could pave way to new indications
Results from trials of both Medtronic‘s (NYSE:MDT) and Edwards Lifesciences‘ (NYSE:EW) transcatheter aortic valve replacement systems exploring their use in low-risk patients indicated that the devices were as safe as open surgery, paving the way for possible new indications for TAVR technology. Data from the trials were presented over the weekend at the American College of Cardiology 68th Annual Scientific Session 2019 in New Orleans and simultaneously published in the New England Journal of Medicine. Currently, TAVR devices are only approved by the FDA for treating severe aortic valve stenosis in patients at inte...
Source: Mass Device - March 18, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Featured Replacement Heart Valves Edwards Lifesciences Medtronic Source Type: news

Study: Edwards’ Sapien and Medtronic’s CoreValve outcomes are similar
A new study published in the Journal of the American College of Cardiology found that patients treated with Edwards Lifesciences‘s (NYSE:EW) and Medtronic‘s (NYSE:MDT) CoreValve showed similar results after 1 year. The 241-patient trial examined high-risk patients with symptomatic severe aortic stenosis 1 year after being treated with either Edwards’s Sapien balloon expanding or Medtronic’ self-expanding transcatheter heart valve. The rates of all-cause death and cardiovascular death were not statistically different between the groups, with a 3-5% difference between the 2 devices, according to the ...
Source: Mass Device - August 11, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Edwards Lifesciences medtronic Source Type: news

Study: TAVR safer than surgery in low-risk heart failure patients
Transcatheter aortic valve replacement procedures with self-expanding systems resulted in higher survival rates for patients at lower risk for surgery when compared to surgical aortic valve replacement procedures, according to a study released this month. Results from the study, which compared Medtronic‘s (NYSE:MDT) self-expanding CoreValve TAVR system, were published in JAMA Cardiology this month. The retrospective analysis compared patients from the CoreValve U.S. pivotal high-risk trial of patients with STS PROM scores of 7% or less who either underwent TAVR procedures or surgery, with a median STS Prom score of...
Source: Mass Device - August 29, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Medtronic Source Type: news

Mitralign raises $10m
Mitralign, which is looking to commercialize its namesake mitral valve treatment and pursue regulatory nods for its Trialign tricuspid valve device, said it raised nearly $10 million. The $9.8 million funding, of a hoped-for $30.2 million, came from 19 unnamed investors beginning last September, the Tewksbury, Mass.-based company said in a regulatory filing. Mitralign raised a $40 million Series E round in May 2016. The Mitralign and Trialign devices are designed to use wire and catheters to implant polyester anchors within the annulus of the mitral and tricuspid valves. The anchors are then cinched together to reduce v...
Source: Mass Device - February 21, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Funding Roundup Replacement Heart Valves Wall Street Beat Mitralign Inc. Source Type: news