The FDA has yet another private listing of device-related deaths, this one for transcatheter aortic valve replacement (TAVR) devices that include Medtronic’s (NYSE:MDT) CoreValve and Edwards Lifesciences’ (NYSE:EW) Sapien 3 lines, according to a new report by Kaiser Health News. Both devices were initially indicated for patients who were too frail or ill for open-heart surgery, but the FDA subsequently approved […]
CryoLife to begin investigational trial on using aortic valve without warfarin
CryoLife Inc. (NYSE:CRY) announced that it had its investigational new drug application accepted by the FDA for a clinical trial to observe whether the On-X mechanical aortic valve can be maintained on apixaban instead of warfarin. The On-X aortic valve is the first mechanical aortic heart valve to win FDA and CE Mark approval for labeling […]
Report: Mayo Clinic to try Corindus telestenting
Mayo Clinic researchers this spring plan to try out Corindus’ telestenting technology — which Mayo officials think could improve care in the rural hospitals in their network, according to a report in the Star Tribune of Minneapolis. Corindus told MassDevice‘s sister site Medical Design & Outsourcing in 2018 that the company had a partnership with […]
Adagio Medical starts iCLAS AFib trial
Adagio Medical announced that it enrolled the first patient in its iCLAS investigational device exemption clinical trial for assessing the treatment for persistent atrial fibrillation. The iCLAS is a low-temperature intelligent continuous legion ablation system. The FDA-approved study has the goal of evaluating the safety and efficacy of the system in PsAF to support pre-market approval […]
iRhythm touts AFib study
iRhythm Technologies (NSDQ:IRTC) announced that it is participating in a new Bristol-Myers Squibb–Pfizer (NYSE:PFE) Alliance study for reducing stroke by screening for undiagnosed atrial fibrillation in elderly individuals. The goal of the “Guard-AF” study is to determine if earlier detection of AFib can impact the rate of stroke through screening previously undiagnosed people who are at least […]
ControlRad adds five people to leadership team
ControlRad announced today that it made several additions to its leadership team, naming a new chief financial officer, VP of U.S. operations, VP of marketing and two new VPs of sales. The Atlanta-based company named Peter Pizzo as its new CFO. Pizzo has more than 25 years of experience in senior financial roles, having previously […]
Cook Medical issues Class I recall of CrossCath Support Catheters
Cook Medical is recalling its CrossCath Support catheters due to potential marker bands dislodging or buckling in a Class I recall. Cook Medical said an error occurred during manufacturing that could cause radiopaque marker bands to be too loose on some CXC3.0 CrossCath Support Catheters and could be too tight on certain CXC3.4 CrossCath Support […]
New trial for Abiomed’s Impella looks for heart failure reduction
Heart pump company Abiomed (NSDQ:ABMD) has begun a clinical trial to determine whether pumping blood from the left ventricle after a heart attack will reduce the amount of dead tissue. The ST-Elevation Myocardial Infarction Door-to-Unloading (STEMI DTU) randomized controlled trial will explore whether using the company’s Impella heart pump to unload the left ventricle for […]
Robocath completes first robotic coronary angioplasties in Africa
Robocath announced today that it successfully completed the first robotic coronary angioplasties on the continent of Africa with its R-One system. The Rouen, France-based company performed six successful robotic coronary angioplasties in Cape Town. Netcare Christiaan Barnard Memorial Hospital interventional cardiologist Dr. Faizel Lorgat performed the percutaneous coronary interventions as part of a distribution agreement […]
Barry out as InspireMD CEO
InspireMD (NYSE:NSPR) announced today that president & CEO James Barry is stepping down, effective Dec. 31, to pursue other opportunities. InspireMD is facing a potential de-listing from the New York Stock Exchange after reporting stockholders’ equity of less than $6 million as of June 30 and net losses for the last five years. The company […]
Schiller issues field safety notice for Tempus LS defibrillators
Schiller has issued a field safety notice for its Tempus LS defibrillator for impedance out of valid range and unexpected safety discharge. The company received notice about an impedance change between a patient and the device that could cause an impairment of the impedance measurement. If the impedance is out of a valid range, defibrillation […]
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