Elixir Medical Corporation, a developer of product platforms that combine innovative medical devices with potent pharmaceuticals for site-specific therapies, announced the initiation of patient enrollment in the EXCELLA BD Randomized Clinical Trial designed to evaluate Elixir's next generation Novolimus Eluting Coronary Stent System (CSS) with bioabsorbable coating, the Elixir DESyne BD Novolimus Eluting CSS. The first cases were enrolled by Professor Joachim Schofer from the Universitäres Herz-und Gefäβzentrum in Hamburg, Germany and Dr. Karl E. Hauptmann from the Krankenhaus der Barmherzigen Brüder in Trier, Germany.
“We are excited to initiate this trial. The DESyne BD CSS is an important platform in our comprehensive portfolio of products designed to address patient and physician needs”
"We are pleased to initiate the trial and participate in the development of this exciting next generation drug eluting stent system with the bioabsorbable coating technology," said Professor J. Schofer, M.D., Ph.D.
The Elixir DESyne BD Stent combines a low drug dose (5µg/mm stent length) of the novel, internally developed macrocyclic lactone Novolimus, a metabolite of sirolimus, and a low polymer load of a proprietary polylactide-based bioabsorbable polymer resulting in one of the thinnest coatings (<3 µm) available on a polymer-coated drug eluting stent (DES) system. The polymer is applied onto the stent without the need for an underlying primer polymer coating and is designed to bioabsorb over several months leaving behind a bare metal stent. In the First-in-Man Study, the stent demonstrated excellent preliminary safety and efficacy with an in-stent late lumen loss of 0.16mm at 6 months and no Major Adverse Cardiac Events (MACE) through 12 months.
"We look forward to the prospect of improving clinical outcomes with this next generation drug eluting stent," said Dr. K. Hauptmann, M.D.
EXCELLA BD is a randomized, single-blind, multi-center clinical trial designed to enroll 145 patients at 10 sites in Europe and Brazil. The trial will compare the DESyne BD CSS to the Medtronic Endeavor Zotarolimus Eluting CSS. The primary endpoint of the trial is the in-stent late lumen loss at 6 months measured using quantitative coronary angiography (QCA) with an additional evaluation in a sub-set of patients by intravascular ultrasound (IVUS) at 6 months. The clinical endpoint is based on a device-oriented composite endpoint defined as cardiac death, myocardial infarction not attributable to a non-interventional vessel and clinically-indicated target lesion revascularization. All patients will be followed clinically at 1, 6, 9 and 12 months and annually for 5 years.
Principal Investigators for the trial are Professor Alexandre Abizaid, M.D. Ph.D. at the Instituto Dante Pazzanese in Sao Paulo, Brazil and Professor Stefan Verheye, M.D., Ph.D. at ZNA Middelheim in Antwerpen, Belgium.
"Elixir continues to innovate and build upon the impressive results achieved in the EXCELLA II randomized trial which demonstrated a 0.11mm in-stent late lumen loss at 9 months using the ultra-thin durable polymer coating technology incorporating a low Novolimus drug dose of 5 µg/mm of stent length. This new and exciting ultra-thin bioabsorbable polymer coating technology using the same low drug dose positions Elixir with a strong next generation platform," said Professor A. Abizaid, M.D., Ph.D.
"The ultra-thin bioabsorbable polymer coating technology in combination with a low drug dose has the potential to achieve excellent efficacy while further reducing adverse clinical events such as late stent thrombosis," commented Professor S. Verheye, M.D., Ph.D.
"We are excited to initiate this trial. The DESyne BD CSS is an important platform in our comprehensive portfolio of products designed to address patient and physician needs," said Motasim Sirhan, Chief Executive Officer of Elixir Medical.
Elixir Medical Corporation also announced a key presentation scheduled for the 2010 TCT meeting featuring the company's cardiovascular innovations.
Wednesday, 22 September 2010
Next Generation DES with Bioabsorbable Polymers, Ballroom C: 9:18 AM
"Overview of Novolimus Elution and Myolimus Elution from Durable and Bioabsorbable Polymers." Presented by Professor Stefan Verheye, M.D., PhD. of ZNA Middelheim Hospital in Antwerpen, Belgium.
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