Penumbra (NYSE:PEN) yesterday posted first-quarter results that topped the consensus forecast on Wall Street and guided toward the high end of its full-year sales outlook. The Alameda, Calif.-based neurovascular device maker reported profits of $10.7 million, or 30¢ per share, on sales of $128.4 million for the three months ended March 31, growing the bottom […]
Vascular
Rapid Medical wins FDA nod for Comaneci embolization assist device
Rapid Medical said today that it won FDA 510(k) clearance for its Comaneci device, now cleared as a temporary coil embolization assist system. The Israel-based company said that the Comaneci is the first and only device cleared by the FDA in a new category of temporary coil embolization assist devices. The Comaneci is an adjustable, […]
FDA grants breakthrough nod to Concept Medical for MagicTouch DCB
Medtech developer Concept Medical said today it won FDA breakthrough device designation for its MagicTouch sirolimus drug-coated balloon catheter designed for the treatment of coronary in-stent restenosis. The device is cleared for treating patient’s who’ve experienced a re-narrowing of a stented coronary artery lesion due to subsequent tissue proliferation at the stented site, the Tampa, Fla.-based company […]
FDA: Edward’s select recall of Miller, Fogarty atrioseptostomy caths is Class I
The FDA has classified a select recall of Edwards Lifesciences (NYSE:EW) Miller and Fogarty atrioseptostomy catheters over balloon deflation, fragmentation and detachment issues as Class I. Class I designations, the FDA’s most severe, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death. The Miller Balloon catheter […]
Nipro’s Infraredx wins expanded FDA nod for Makoto intravascular imager
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 […]