Controversy reportedly erupted at a European cardiovascular society conference this week after a prominent cardiologist accused the study’s investigators of manipulating the trial to skew the results. Five-year data from the Excel trial, released last month at the Transcatheter Cardiovascular Therapies conference, showed that percutaneous coronary intervention was as good as coronary artery bypass grafts […]
Valfix Medical pulls in $1m for dual heart valve repair-replacement device
Valfix Medical this week filed an SEC Form D reporting that it sold more than $1 million in an equity offering. The Tel Aviv, Israel-based biotech company’s new notice completed its first sale on August 22 and does not intend for the equity offering to extend beyond one year, according to the filing. The total […]
Edwards Lifesciences to put $100m into Costa Rica expansion
Edwards Lifesciences (NYSE:EW) is slated to add a $100 million expansion and 500 new jobs by the end of 2020 in an effort to expand its operations in Costa Rica, according to the Costa Rican Investment Promotion Agency. The Irvine, Calif.-based company established cardiac device manufacturing facilities in Cartago in 2016, announcing a plan to add […]
FDA grants breakthrough nod for Corvia’s interatrial shunt
Corvia Medical said today that it won FDA breakthrough device designation for its interatrial shunt device for heart failure. The Tewksbury, Mass.-based company’s interatrial shunt is designed to lower blood pressure in the left atrium and lungs by creating a small opening between the left and right atria. It’s the world’s first transcatheter device indicated […]
Study: Abbott, Edwards may have mislabeled hundreds of patient deaths
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 […]
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, […]
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. […]
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