This report has been updated with comments from Edwards Lifesciences, Madris Tomes and the FDA. Abbott (NYSE:ABT) and Edwards Lifesciences (NYSE:EW) may have mislabeled patient deaths as injuries or device malfunctions in hundreds of FDA adverse event reports involving their transcatheter aortic or mitral valve replacement devices, according to a new study. The study by JAMA […]
BioVentrix launches trial for Revivent TC heart failure device
BioVentrix said today that it enrolled and treated the first patient in its Revive-HF European trial to evaluate the Revivent TC system for the treatment of ischemic cardiomyopathy-induced heart failure. The patient, who had suffered a heart attack that resulted in left ventricle scarring and ischemic heart failure, was successfully implanted with three anchor pairs […]
Medtronic wins FDA breakthrough nod for Valiant stent graft
Medtronic (NYSE:MDT) said today that it won breakthrough device designation from the FDA for its Valiant TAAA stent graft for treating thoracoabdominal aortic aneurysms. The newest Valiant graft is designed for minimally invasive repair of TAAA, a complex condition that causes a bulging of the aorta. The standard of care is open surgery, which is associated […]
FDA OKs PQ Bypass trial of Torus peripheral stent graft
PQ Bypass said today that it won full FDA approval of its investigational device exemption trial for the Torus stent graft for treating peripheral artery disease. The Torus stent graft is designed to treat PAD in the superficial femoral artery by aiding in halting the progression of the disease, rather than solely treat the symptoms, […]
DeviceTalks Minnesota 2019: Exhibitor insights you need to know
There were a host of medtech insights to be gained on the exhibitor floor of DeviceTalks Minnesota in September, from LVAD innovations at Abbott to cybersecurity tips from Green Hills Software to Xometry’s use of AI to help device makers secure better 3D printing and other manufacturing processes. Check out what editor Chris Newmarker discovered […]
Medtronic launches trial for extravascular ICD
Medtronic (NYSE:MDT) said today that it launched a worldwide pivotal study to evaluate its extravascular implantable cardioverter defibrillator device for treating dangerously fast heart rhythms. The EV ICD system uses a device that is the same size as traditional, transvenous ICDs, but with a lead wire placed outside the heart and veins, designed to deliver defibrillation […]
Report: Docs could reduce adverse events with Boston Sci’s Watchman
This article has been updated to include comments from Boston Scientific. A recent review of FDA files has found nearly 3,000 adverse events related to Boston Scientific’s (NYSE:BSX) Watchman device. The Watchman left atrial appendage closure device, approved by the agency in March 2015, is designed to prevent blood clots that form in the heart’s […]
Gore wins CE Mark for Cardioform ASD septal occluder
W.L. Gore said yesterday that it won CE Mark approval in the European Union for its Cardioform ASD septal occluder for the percutaneous, transcatheter closure of ostium secundum atrial defects. The device won pre-market approval from the FDA for Cardioform ASD in June. The device is designed to close atrial septum defects of 8mm to 35mm […]
4C Medical pulls in $8m
4C Medical Technologies secured more than $8 million in an equity offering it hopes will reach the $20 million mark. The Maple Grove, Minn.-based company raised nearly $8.2 million in the offering, with $11.8 million remaining to be sold, according to an SEC Form D filed today. Forty-five unnamed investors have contributed to the offering. […]
Maquet recalls arterial filters
Getinge subsidiary Maquet Cardiovascular is recalling its Quart arterial filter, used during coronary bypass surgery, because transportation may compromise its sterile packaging. A transportation simulation test revealed the problem, according to an August 27, 2019, letter to customers. Patients who are exposed to non-sterile medical devices while undergoing extracorporeal circulation may develop an infection and […]
ControlRad drums up $15m Series B round
ControlRad said today that it completed a $15 million Series B round for the commercial launch of its Trace system for reducing radiation in fluoroscopically guided procedures. Norcross, Ga.-based ControlRad’s Trace system is the first FDA-cleared technology that can be integrated into existing mobile C-arms to reduce the ionizing radiation that can occur in FGP. […]
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