Elixir Medical Corporation Announces Excellent Six-Month Safety and Efficacy Results from the EXCELLA BD Randomized Clinical Trial for DESyne BD Novolimus Eluting Coronary Stent with Biodegradable Polymer
2-Year Data from EXCELLA II Trial Confirm Sustained Performance of DESyne™ Novolimus Eluting Stent with Durable Polymer
SUNNYVALE, Calif.--(BUSINESS WIRE)--Nov 9, 2011 - Elixir Medical Corporation, a developer of products that combine state-of-the-art medical devices with advanced pharmaceuticals, announced six-month randomized clinical trial results today demonstrating the superiority of the Elixir DESyne™ BD Novolimus Eluting Coronary Stent System compared to the control Endeavor® Zotarolimus Eluting Coronary Stent System in the primary endpoint of in-stent late lumen loss and the secondary endpoint of binary restenosis.
The Elixir DESyne BD Stent uses a proprietary technology to enable an ultrathin (< 3 microns) drug-polymer coating without the need for an underlying primer layer. The 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. The DESyne BD System comprises of a cobalt chromium alloy stent coated with a biodegradable polylactide-based polymer and Elixir's novel macrocyclic lactone compound Novolimus, achieving excellent clinical outcomes as compared to the leading commercially available drug eluting stent systems.
Six-month clinical, angiographic and IVUS 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 San Francisco at the Annual Transcatheter Therapeutics (TCT) Conference by 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 six months, the Elixir DESyne BD Stent 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, 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 EXCELLA BD trial results position DESyne BD Novolimus Eluting Stent System as a strong next-generation DES providing physicians a promising technology to improve clinical outcomes,” said Professor Alexandre Abizaid, M.D., Ph.D. “The Elixir DESyne BD Coronary Stent System is poised to be competitive with the best-in-class drug eluting stent systems in the clinic.”
“The superior in-stent late loss and IVUS results will make DESyne BD an extraordinary tool for clinicians to save patient lives,” said Professor Stefan Verheye, M.D., Ph.D., ZNA Middleheim Hospital, Antwerp, Belgium, and Co-Principal Investigator of EXCELLA BD. “I am excited about the DESyne BD polymer dissolving within 6-9 months, leaving behind a desired bare metal stent surface.”
Two-Year Results of EXCELLA II Clinical Trial Reaffirm Sustained Performance of Elixir Medical's DESyne™ Novolimus Eluting Stent System
Excellent two-year results using Elixir Medical's now CE Mark approved Novolimus Eluting Coronary Stent System from the EXCELLA II trial were also presented at the 23rd annual TCT conference by Joachim Schofer, M.D., Ph.D., Hamburg University Cardiovascular Center, Germany. The EXCELLA II trial was a multi-center, randomized, single blind, evaluation of the Elixir DESyne Novolimus Eluting Coronary Stent System (with a durable polymer coating) compared to the control Endeavor Zotarolimus Eluting Coronary Stent System. The study enrolled 210 patients from Europe, Australia, New Zealand and Brazil. The primary endpoint was in-stent late lumen loss assessed by quantitative coronary angiography (QCA) at nine months. Secondary endpoints of the study include: device-orientated composite endpoints (DoCE) and stent thrombosis rates at 30 days; 6, 9, 12, and 24 months; with annual clinical follow-up to 5 years. A subset of patients underwent intravascular ultrasound (IVUS) evaluation at 9 months.
At nine month angiographic and IVUS follow-up, Elixir Medical's DESyneTM stent demonstrated superiority over the Endeavor stent for the primary endpoint of in-stent late lumen loss (0.11±0.32 vs. 0.63±0.42, p<0.001). IVUS results mirrored the angiographic results demonstrating a statistically significant reduction in percent neointimal obstruction rate for the DESyne stent versus the Endeavor stent (4.5 ±5.1% vs. 20.9±11.3, p<0.001).
At the two year endpoint, the clinical event rates as measured by DoCE for DESyne remained unchanged from the 12-month point and were 4.3%. During the same period, the DoCE for the control Endeavor stent had increased from 7.0% to 9.9%. Clinically-indicated TLR (Target Lesion Revascularization) at the 2-year mark was significantly lower for the DESyne stent at 1.4% compared to 7.0% for Endeavor stent (p=0.045).
“I am very pleased by the sustainability of the excellent clinical results of Elixir's DESyne Novolimus Eluting Coronary Stent System at this two-year follow-up milestone,” said Joachim Schofer, M.D., Ph.D. “The unchanged DoCE and clinically-indicated TLR rates from year one to year two substantially differentiates this system from other available DES systems.”
“The excellent six-month data from the EXCELLA BD trial and two-year results from the EXCELLA II trial further reinforce the safety and effectiveness of the Novolimus compound in multiple product platforms,” said Motasim Sirhan, Chief Executive Officer of Elixir Medical. “Elixir's multiple products of durable polymer coating in DESyne and biodegradable polymer coating in DESyne BD will enable the company to offer physicians better treatment options for their patients' diverse needs.”
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 systems are designed to optimize localized drug delivery to provide a safe and effective treatment for cardiovascular patients. For more information, visit www.elixirmedical.com.
Contact: Elixir Medical Corporation
Vinayak Bhat, PhD, 408-636-2006
Posted: November 2011