Healthcare Industry News: thrombosis
News Release - May 15, 2012
Elixir Medical Announces Continued Excellent One Year Safety and Efficacy Data from the EXCELLA BD Randomized Clinical Trial for DESyne BD(TM) Novolimus Eluting Coronary Stent with Biodegradable PolymerSUNNYVALE, Calif.--(Healthcare Sales & Marketing Network)--Elixir Medical Corporation, a developer of products that combine state-of-the-art medical devices with advanced pharmaceuticals, announced one-year randomized clinical trial results today demonstrating the continued safety and efficacy of the Elixir DESyne™ BD Novolimus Eluting Coronary Stent System.
The DESyne BD System comprises a cobalt chromium alloy stent, a proprietary technology to incorporate an ultrathin (<3 microns) biodegradable polylactide-based polymer coating, and Elixir’s novel macrocyclic lactone compound Novolimus, eliminating the need for a primer layer. The biodegradable polymer enables the sustained release of the drug to the coronary vessel wall and degrades within 6-9 months, leaving behind the bare metal stent surface while maintaining the efficacy of a workhorse drug eluting stent. Conformité Européenne (CE) Mark approval for DESyne BD is anticipated in the second half of 2012.
One year clinical results from the EXCELLA BD randomized clinical trial evaluating the Elixir DESyne BD Novolimus Eluting Coronary Stent System compared to the control Endeavor Zotarolimus Eluting Coronary Stent System were presented on behalf of the EXCELLA BD investigators in Paris, France, at the annual EuroPCR Conference by Professor Alexandre Abizaid, M.D., Ph.D., The Instituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil, and Co-Principal Investigator for the trial. The study enrolled 151 patients in Europe, Australia, New Zealand and Brazil.
At one year, clinical events measured using the device-oriented composite endpoint (DoCE) for Elixir’s DESyne BD Novolimus Eluting Stent system was low, and remained unchanged from six-month results at 2.7% as compared to 3.2% for the Endeavor Zotarolimus Eluting Coronary Stent System control. There were no cases of stent thrombosis for DESyne BD through the one year end point.
At six months, the Elixir DESyne BD Stent had demonstrated not only non-inferiority (p<0.001) but also superiority (p<0.001) over the Endeavor stent for the primary endpoint of in-stent late lumen loss (0.12±0.17 vs. 0.67±0.47, p<0.001), and for the secondary end point of binary restenosis (0% vs. 7.9%, p=0.003). In a subset of patients who underwent intravascular ultrasound (IVUS) imaging at six months, the findings mirrored the angiographic results demonstrating a statistically significant reduction in percent neointimal obstruction for the DESyne BD stent versus the Endeavor stent (3.6 ±4.2% vs. 20.7±14.2, p<0.001). Clinical events measured using the device-oriented composite endpoint (DoCE) were low for both groups (2.7% vs. 3.2%, DESyne BD vs. Endeavor).
“The strong and sustained EXCELLA BD trial results at 12 months position DESyne BD Novolimus Eluting Stent System as a cutting-edge DES,” said Professor Alexandre Abizaid, M.D., Ph.D. “I am excited about the potential clinical benefits of the DESyne BD with a biodegradable polymer that dissolves within 6-9 months, leaving behind a desired bare metal stent surface.”
“The one-year data from the EXCELLA BD trial reinforces the excellent safety and effectiveness of Elixir’s Novolimus compound across multiple product platforms,” said Motasim Sirhan, Chief Executive Officer of Elixir Medical. “Elixir is committed to offering physicians the broadest portfolio of interventional cardiology therapies to improve patient outcomes.”
Novolimus, a metabolite of sirolimus, was developed internally by Elixir for use in site- specific therapies. Novolimus belongs to the powerful macrocyclic lactone class of drugs, which have established safety and efficacy profiles. This family of drugs is the most widely used for drug eluting stent applications.
About Elixir Medical
Elixir Medical Corporation, a privately held company headquartered in Sunnyvale, California, develops products that combine state-of-the-art medical devices with advanced pharmaceuticals to provide innovative treatment solutions to patients worldwide. The company’s next-generation drug-eluting stent and bioresorbable scaffold systems are designed to optimize local drug delivery to provide a safe and effective treatment for cardiovascular disease. For more information about the company, its products and clinical data, please visit http://www.elixirmedical.com.
Source: Elixir Medical
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