Stryker (NYSE:SYK) said today that it won FDA premarket approval for its Neuroform Atlas stent system intended for use in treating wide-neck, intracranial aneurysms in conjunction with embolic detachable coils. The Neuroform Atlas stent system previously won approval from the FDA under a humanitarian device exemption which restricted its use to specific hospitals with institutional […]
Vascular
Philips launches IntraSight interventional lab applications platform
Royal Philips (NYSE:PHG) said today that it launched its IntraSight interventional lab applications platform designed to provide clinically proven iFR, FFR, IVUS and co-registration modalities intended to simplify complex interventions and hasten routine procedures. The IntraSight platform features a touchscreen control, systems integration, data management and remote service diagnostics, the Amsterdam-based company said. Philips said that […]
Judge: Ex-Abbott worker can’t sue twice
A federal judge in Massachusetts yesterday shot down a second lawsuit brought against Abbott (NYSE:ABT) by a former medical liaison over her claim that the company fired her after she blew the whistle on off-label and pre-approval stent promotion. Ebonia Elliott-Lewis, formerly a regional science manager for Abbott Vascular based in Boston, first sued the company […]
Velano Vascular raises $10m
Velano Vascular said today that it raised $10 million in a new round of financing to support its novel vascular access solutions. The round was joined by strategic investor Intermountain Healthcare, Kapor Capital, Marc Benioff, former Baxter International CEO Robert Parkinson and former BD CEO Edwards Ludwig, the San Francisco-based company said. Velano said that […]
Penumbra tops estimates with Q1 results, guides to high end of sales forecast
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 […]
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 […]