Elixir Medical announced today that it received FDA breakthrough device designation for its DynamX bioadaptive implant. The breakthrough nod covers the improvement of coronary luminal diameter, restoration of hemodynamic modulation and reduction of plaque progression in patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions. It follows a March […]
Elixir Medical Corporation
EuroPCR 2019: Elixir Medical touts DynamX
Elixir Medical touted clinical and imaging results from a study of its DynamX drug-eluting stent, which is designed to restore normal pulsatility and adaptive remodeling in blood vessels after treating a coronary lesion. DynamX, introduced in 2017 at the annual Transcatheter Cardiovascular Therapeutics meeting, is a cobalt-chromium stent with a biodegradable polymer coating that releases […]
Elixir Medical unveils ‘bioadaptive’ metallic drug-eluting stent at TCT 2017
Interventional cardiologists have used stents to keep the heart’s coronary arteries open for decades. Transitioning from bare-metal stents to drug-eluting stents in the early 2000s brought tremendous benefits for patients. “But over the last 10 years, the technological progress and meaningful clinical improvements have plateaued,” Elixir Medical CEO Motasim Sirhan told Drug Delivery Business News. “When you stent an artery […]
European task force: Docs should favor drug-eluting stents over bioresorbable scaffolds
Physicians should not use bioresorbable scaffolds in place of current-generation drug-eluting stents, according to a report from the European Society of Cardiology and European Association of Percutaneous Cardiovascular Inventions. The ECS/EAPCI report says that as long as concerns remain about the increased risk of myocardial infarction and scaffold thrombosis linked with bioresorbable scaffolds, physicians should […]
Reva Medical wins CE Mark for Fantom bioresorbable scaffold
Reva Medical (ASX:RVA) said yesterday that it won CE Mark approval in the European Union for its Fantom sirolimus-eluting bioresorbable coronary scaffold. The Fantom scaffold is the San Diego, Calif.-based company’s 1st commercial product. Reva said it plans to begin selling the product in Europe this quarter. “CE Mark approval for Fantom is a major milestone for […]
Elixir Medical’s DeSyne stent tops Medtronic’s Endeavor after 5 years
Elixir Medical‘s novolimus-eluting stent, DeSyne, outperformed Medtronic‘s (NYSE:MDT) zotarolimus-eluting stent, Endeavor, according to long-term data from Elixir’s Excella II trial. The study enrolled 210 patients with 2 or more de novo lesions in 2 different epicardial vessels. Researchers randomly assigned patients in a 2:1 ratio to the novolimus-eluting stent or the zotarolimus-eluting stent. The device emits a low […]
Akesys, Elixir Medical tout 1st implant for Prava bioresorbable peripheral stent
Akesys Medical and Elixir Medical Corporation said today that it implanted its 1st Prava sirolimus eluting bioresorbable peripheral scaffold for the treatment of blockages in the superficial femoral artery. The scaffold was developed to keep the large artery in the thigh open and restore blood flow to the leg and resorb into the body, making […]
