Medtronic (NYSE:MDT) said today that it’s launching a study in the U.S. and Japan to evaluate dual antiplatelet therapy in high bleeding risk patients implanted with the Resolute Onyx drug-eluting stent during percutaneous coronary intervention. The company’s Onyx One Clear study is one of the first designed to assess the risk of cardiac death and stent […]
Boston Scientific launches trial for drug-eluting peripheral stent
Boston Scientific (NYSE:BSX) said last week that it enrolled the first patient in a pivotal trial to evaluate its below-the-knee drug-eluting stent in patients with critical limb ischemia. The peripheral stent is the first of its kind to undergo the FDA’s breakthrough device program, according to the medtech giant. Get the full story at our sister […]
Gore picks up stealthy Pipeline Medical and its mitral repair program
W.L. Gore & Assoc. said today that it acquired stealthy Pipeline Medical Technologies and its mitral repair program for an undisclosed amount. Santa Rosa, Calif.-based Pipleline is developing a transcatheter device designed to duplicate the efficacy and outcomes found when mitral valve chords are repaired via open heart surgery. Gore said it plans to run the […]
Vascular Dynamics launches pivotal trial for MobiusHD hypertension device
Vascular Dynamics said yesterday that it launched a pivotal trial of its MobiusHD device to treat high blood pressure ahead of a bid for a nod from the FDA. The MobiusHD device is designed to help regulate blood pressure by reshaping the the carotid artery to stimulate baroreceptors and increase the body’s natural response to lower blood […]
MicroPort’s drug-eluting stent performs well in European study
MicroPort Scientific’s Firehawk rapamycin target eluting coronary stent performed comparably to Abbott’s Xience stent family in a study just published in The Lancet. The TARGET AC multi-center, randomized controlled trial enrolled 1,653 patients at 21 clinical study sites in Europe. Firehawk met the trial’s non-inferiority primary endpoint of target lesion failure rate at 12 months of 6.1% versus 5.9% for the […]
Miracor Medical closes $35m Series D
Miracor Medical Systems said today it raised $34.6 million (EU €30 million) Series D round of financing to help support the development and commercialization of its PiCSO Impulse System. The round was led by Ming Capital and co-led by a strategic investor, the Belgium-based company said. The round was also joined by newly invested Belgian […]
SynCardia responds to FDA note warning of high rates of stroke, mortality risk with TAH-t C2 Driver
SynCardia Systems this week responded to an FDA notice warning about a higher mortality risk and stroke rate with the company’s Temporary Total Artificial Heart Companion 2 Driver System noted as part of a post-approval study of the device. In its response, the Tucson, Ariz.-based company said that the FDA letter, which warned of risks associated […]
Climb every mountain, armed with cardiac info
Cardiac Insight’s Cardea Solo wearable electrocardiogram sensor was put to the test in May when a climbing team scaled North America’s highest peak to gather previously limited high-altitude cardiac data. The mountaineering team, comprised of military members, veterans and a physician from non-profit organization U.S. Expeditions and Explorations (USX) and Cardiac Insight, climbed Denali in Alaska to measure […]
Medtronic touts 1-year Arctic Front cryoballoon study data
Medtronic (NYSE:MDT) today released results from the Cryo4Persistent AF clinical trial of its Arctic Front Advance cryoablation system, touting reductions in the symptoms of abnormal heart rhythms and a low rate of re-interventions and repeat ablations. The Fridley, Minn.-based company said it presented results from the trial at the 2018 European Society of Cardiology Congress in […]
Corvia Medical’s interatrial shunt study meets endpoints
Corvia Medical said today that a clinical trial of its Interatrial Shunt Device for treating heart failure met its primary endpoints at one year. Tewksbury, Mass.-based Corvia last November launched the Reduce LAP-HF II clinical trial ahead of a bid for FDA approval. The company’s IASD is designed to lower blood pressure in the left atrium and […]
Gore tests stent graft for deadly heart condition
W. L. Gore & Associates announced the first implant of its ascending stent graft, an investigational device and the only endovascular stent graft specifically designed to treat Type A dissections of the ascending aorta. The surgery was part of Gore’s ARISE study, the first multicenter, early feasibility study approved by the FDA to investigate how […]
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