September 20, 2010 – Patient enrollment has started in the EXCELLA BD Randomized Clinical Trial designed to evaluate Elixir Medical’s novolimus-eluting coronary stent with bioabsorbable coating, the Elixir DESyne BD. The first cases were enrolled by professor Joachim Schofer from the Universitäres Herz-und Gefä?zentrum in Hamburg, Germany, and Dr. Karl E. Hauptmann from the Krankenhaus der Barmherzigen Brüder in Trier, Germany.
“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 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 (less than 3µm) 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 0.16 mm at six months and no major adverse cardiac events (MACE) through 12 months.
EXCELLA BD is a randomized, single-blind, multicenter 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 stent. The primary endpoint of the trial is the in-stent late lumen loss at six months measured using quantitative coronary angiography (QCA) with an additional evaluation in a sub-set of patients by intravascular ultrasound (IVUS) at six 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 one, six, nine and 12 months and annually for five 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 0.11 mm in-stent late lumen loss at nine months using the ultra-thin durable polymer coating technology incorporating a low novolimus drug dose of 5µg/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," Abizaid said.
“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,” Verheye said.
Elixir Medical also announced a key presentation scheduled for the 2010 Transcatheter Cardiovascular Therapeutics (TCT) meeting. The session, “Next Generation DES with Bioabsorbable Polymers,” will be presented at 9:18 a.m. Wednesday, Sept. 22, in Ballroom C. Professor Verheye will present “Overview of Novolimus Elution and Myolimus Elution from Durable and Bioabsorbable Polymers.”
For more information: www.elixirmedical.com