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 today, you […]
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 […]
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. Get the full story at […]
St. Jude Medical (NYSE:STJ) said today that its newly acquired HeartMate PHP heart pump met its safety and efficacy endpoints in the Shield I trial used to back its CE Mark approval last summer. The results from Shield I’s 1st 30 patients led to the CE Mark nod in July. Today St. Jude said data from 46 subjects […]
Stryker (NYSE:SYK) said yesterday that it’s eliminating the role of international president held by Ramesh Subrahmanian as it reorganizes its overseas business. After Subrahmanian’s departure, effective Dec. 31, he’s slated to stay on until March 31, 2016, as an advisor, Stryker said in a regulatory filing. International sales were down across the board during Stryker’s […]
California stent-maker Elixir Medical won approval from European regulators for its next-generation DESolve 100 fully resorbable coronary scaffold.
Elixir Medical’s DESolve Novolimus eluting bioresorbable coronary scaffold system won European CE Mark approval, the privately held Sunnyvale, Calif.-based company announced today.
DESolve is designed to degrade in about 1 year, returning the patients’ coronary vessel to its normal de novo state.
Elixir plans to initiate commercial sales of DESolve in a broad range of sizes in select international markets later this year, according to a press announcement.
With a green-light from the FDA, Elixir Medical Corporation will move forward with its Excella III pivotal trial to review its DESyne Nx Novolimus-eluting coronary stent system. Elixir plans to enroll patients at 50 clinical locations and will use the trial results to support its upcoming premarket approval application.
Elixir Medical won CE Mark approval in the European Union for its DESyne BD drug-eluting stent with a bioabsorbable polymer coating, the company announced this week.
Elixir’s uses proprietary technology to coat the novolimus-eluting DESyne BD stent with an ultra-thin polymer coating that enables sustained drug release and degrades over 6 to 9 months, leaving behind a bare metal cobalt chromium stent.
Disappearing technology had a strong presence at this year’s EuroPCR conference in Paris, with rival device makers demonstrating the safety and efficacy of their next-generation stents.
Elixir Medical unveiled 1st-in-man clinical results for its DESolve fully bioabsorbable drug-eluting scaffold system, a stent made from a proprietary polymer and coated in novolimus. The entire stent is designed to be absorbed by the body in 1-2 years.