CHF Solutions (NSDQ:CHFS) said yesterday that a U.S. Veterans Administration hospital in Florida received approval to begin an outpatient study using its Aquadex FlexFlow system for fluid overload in patients with heart failure. The study, approved by Tampa’s James Haley Veterans’ Hospital & Clinics institutional review board, will be the first of its kind to run […]
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 […]
Penumbra launches trial for Indigo blood clot aspiration device
Penumbra (NYSE:PEN) said today that it enrolled the first patient into its Cheetah study of the Indigo aspiration device. The Alameda, Calif.-based company said the Cheetah trial is slated to enroll up to 400 patients with coronary thrombus who are referred for percutaneous coronary intervention. The study’s primary endpoint is a composition of cardiovascular death, recurrent […]
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 […]
BioCardia wins CE Mark renewal for Helix, Morph catheters
BioCardia (OTC:BCDA) said yesterday that it won CE Mark renewal for its Helix biotherapeutic delivery catheter and Morph universal deflectable guide catheter for delivery of biotherapeutics to the heart. With the renewed CE Mark, BioCardia said it can continue supporting partners outside the U.S. and move forward with commercial sales of the Helix and Morph systems […]
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 […]
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 […]
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