Nipro (TYO: 8086) subsidiary Infraredx said today that it won expanded FDA 510(k) clearance for its Makoto intravascular imaging system, now cleared to identify patients and coronary plaques at an increased risk of major adverse cardiac events. The approval came based on results from the Lipid-Rich Plaque study in which researchers explored the ability of intravascular […]
Terumo’s Microvention touts Web aneurysm embolization study
Terumo (OTC:TRUMY;TYO:4543) subsidiary MicroVention today released results from the WEB-IT pivotal trial of its Web aneurysm embolization system. Results from the trial were published in the online edition of the Journal of NeuroInterventional Surgery, the Aliso Viejo, Calif.-based company said. The trial enrolled a total of 150 patients across 21 U.S. centers and six international centers, MicroVention said. […]
Cook Medical releases patient-level data from Zilver PTX paclitaxel-coated balloon study
Cook Medical said today that it is releasing de-identified patient-level data from a clinical trial of its Zilver PTX peripheral paclitaxel-eluting stent. The move comes only a month after the FDA said that its preliminary review of long-term follow-up data found a “potentially concerning signal” of increased long-term mortality in people with peripheral artery disease […]
Surmodics ticks up on renewed SurVeil DCB trial enrollment
Surmodics (NSDQ:SRDX) shares have ticked up today after the company updated on the TRANSCEND clinical trial of its SurVeil drug-coated balloon, saying that it has resumed patient enrollment in the trial. Last month, the Eden Prairie, Minn.-based company paused enrollment after the FDA wrote a letter to doctors detailing a trend of heightened mortality in people with […]
Medtronic touts five-year VenaSeal study data
Medtronic (NYSE:MDT) today released five-year results from the VeClose extension study of its VenaSeal closure system, touting durable and consistent long-term outcomes with the system when used to treat patients with chronic venous disease. The VenaSeal device is a medical adhesive designed to close off the great saphenous vein for treating chronic venous insufficiency and varicose […]
FDA approves Intact Vascular’s Tack dissection repair device
The FDA last week granted pre-market approval to the Tack endovascular repair device developed by Intact Vascular. The Wayne, Pa.-based company’s Tack system is designed to repair dissection complications during balloon angioplasty for peripheral artery disease. Intact said the federal safety watchdog based the April 11 PMA decision on the results of a pivotal, 213-patient […]
Avinger wins FDA nod for Pantheris SV small vessel atherectomy device
Avinger (NSDQ:AVGR) said today that it won FDA 510(k) clearance for its Pantheris SV small vessel image-guided atherectomy system. The Pantheris SV is an extension of the Redwood City, Calif.-based company’s lumivascular image-guided atherectomy platform which it hopes will expand the available market for its Pantheris devices by up to 50%. The newly cleared device features a […]
UPDATE: Silk Road Medical prices $120m IPO
Updated to include comment from CEO Erica Rogers Silk Road Medical late yesterday priced its initial public offering, looking to raise approximately $120 million. The Sunnyvale, Calif.-based company said it plans to float 6 million shares of its common stock at a price of $20 per share. The offering also includes a 30-day underwriters option to […]
Surmodics shares down following FDA’s paclitaxel device update
Surmodics (NSDQ:SRDX) shares fell last week after the FDA wrote a letter to doctors detailing a trend of heightened mortality in people with peripheral artery disease who were treated with paclitaxel-coated devices. In an SEC filing, the company said that it’s working with the FDA to clarify how the company should proceed with an ongoing clinical trial of […]
FDA updates docs on review of paclitaxel devices for PAD
The FDA said last week that its preliminary review of long-term follow-up data found a “potentially concerning signal” of increased long-term mortality in people with peripheral artery disease who were treated with paclitaxel-coated devices compared to those treated with bare devices. In a letter to healthcare providers, the U.S. regulatory agency reported that there was […]
Late mortality rates ‘inadvertently reversed’ in 5-year study of paclitaxel-eluting stent
The journal Circulation said this week that the all-cause mortality rates in a study comparing a paclitaxel stent and percutaneous transluminal angioplasty in people with peripheral artery disease were “inadvertently reversed” by the authors. In the first version of the paper, originally published in 2016, researchers reported that the 5-year all-cause mortality rate for people treated with Cook […]
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