W.L. Gore & Associates today released 12-month results from a registry study of its Gore Tigris vascular stent designed to treat peripheral artery disease in the superficial femoral artery and proximal popliteal artery, touting that the device was shown to be safe and effective. Results from the trial were presented at the LINC 2019 meeting […]
Vascular
Neovasc touts Reducer study
Neovasc (NSDQ:NVCN) this week touted a newly-published article that described the use of dipyridamole stress perfusion cardiac magnetic resonance to evaluate its Reducer device. The Vancouver-based company’s device is designed to treat refractory angina. The article, published in the Journal of the American College of Cardiology: Cardiovascular Interventions, featured a 66 year old man with angina who […]
CE Mark suspended for Endologix Nellix stent graft
Endologix (NSDQ:ELGX) said yesterday that the CE Mark approval for its Nellix stent graft system designed for treating abdominal aortic aneurysms was suspended by its notified body, GMED. The move follows a halt to unrestricted sales of the stent grafts and a voluntary recall of all existing inventory that the Irvine, Calif.-based company announced earlier this month. […]
Docs plan industry collab to study paclitaxel devices
Non-for-profit org Viva Physicians said yesterday that it will lead a pan-industry effort to study the use of paclitaxel-eluting devices for the treatment of peripheral artery disease in above-the-knee applications. The initiative comes on the heels of a meta-analysis published in the Journal of the American Heart Association this month showing a potential link between increased long-term mortality outcomes […]
Boston Scientific’s Vici venous stent meets primary endpoints at 1 year
Boston Scientific (NYSE:BSX) today touted 12-month data for its Vici venous stent in people with significant obstructions in the illiofemoral venous outflow tract. Researchers reported that the Vici stent met its primary efficacy endpoint with a primary patency rate of 84% at one year. Nearly 99% of people treated with the Vici stent were free from […]
LINC 2019: Medtronic, Boston Scientific back paclitaxel devices amid safety probe
Amid concerns about a potential link between paclitaxel devices and heightened long-term mortality rates, Medtronic (NYSE:MDT) and other device-makers doubled down on their products’ safety at this year’s Leipzig Interventional Course in Germany. Medtronic presented a patient-level survival analysis that included 1,837 patients enrolled in its In.Pact Admiral clinical program. Get the full story at our sister […]
Study of VentureMed’s Flex catheter begins in Switzerland
Vascular-focused device developer VentureMed said yesterday that it has launched another study of its Flex dynamic scoring catheter, this one to measure how open patients’ blood vessels remain 12 months after treatment. The prospective, single arm, non-randomized study in Switzerland will enroll up to 150 patients whose superficial femoral and popliteal arteries were scored by the Flex […]
FDA probes paclitaxel-eluting stents, balloons
The FDA wrote a letter to healthcare providers yesterday on the heels of a meta-analysis that suggested an increased mortality rate after two years in people with peripheral artery disease who were treated with paclitaxel-coated and paclitaxel-eluting devices compared to bare devices. The agency is “evaluating” the new information presented by the study and recommended […]
Johnson & Johnson, Apple ink collab for AFib study
Johnson & Johnson‘s (NYSE:JNJ) Janssen and Apple (NSDQ:AAPL) said today that the two companies inked a deal to study if an app from J&J in combination with the Apple Watch’s ECG app and irregular rhythm notifications can improve outcomes for people living with atrial fibrillation. The study is slated to measure the impact of the Apple Watch on the […]
QT Vascular expands pivotal trial of Chocolate Touch DCB
QT Vascular said today that the FDA approved the company’s request to expand an on-going pivotal study of its Chocolate Touch drug-coated balloon to include the use of atherectomy for lesion preparation. The U.S. regulatory agency also approved the addition of subgroup analysis related to the use of atherectomy. Get the full story at our sister […]
InspireMD inks distro deal for CGuard in South Africa
InspireMD (NYSE:NSPR) said today that it inked a deal with Torque Medical to distribute its CGuard Embolic Prevention System in South Africa. The Israel-based company reported that it will begin the commercial launch for CGuard in South Africa immediately. “We are extremely pleased with the opportunity to offer CGuard EPS in the South African market. We […]