September 29, 2009 – Elixir Medical Corp. last week at TCT 2009 announced positive results from three multicenter first-in-man studies of its novolimus and myolimus-eluting coronary stent systems with durable and bioabsorbable polymers.
Novolimus-Eluting Coronary Stent System With Bioabsorbable Polymer
Nine-month clinical and six-month angiographic and IVUS results from the first-in-man study of novolimus-eluting coronary stent system with Elixir’s proprietary bioabsorbable polymer were presented at TCT 2009 by professor Alexandre Abizaid, M.D., Ph.D., of the Institute of Dante Pazzanese de Cardiologia in Sao Paulo, Brazil, on behalf of the study investigators. At nine months, the novolimus-eluting coronary stent system demonstrated excellent efficacy and clinical safety with no MACE events or incidents of stent thrombosis. Six-month angiographic and IVUS follow-up demonstrated an in-stent late lumen loss of 0.16 ± 0.23 mm and a volume obstruction of 1.6 ± 0.9 percent.
Myolimus-Eluting Coronary Stent System With Bioabsorbable Polymer
Six-month clinical, angiographic and IVUS results from the first-in-man study of the myolimus eluting coronary stent system with the lowest known dose of an ‘olimus’ drug and Elixir’s proprietary bioabsorbable polymer were presented at TCT 2009 by professor Bernard Witzenbichler, M.D., of Charite Campus Benjamin Franklin, Berlin, Germany on behalf of the study investigators. At the six-month follow-up for 30 patients, there were two non-Q-wave myocardial infarctions and one target lesion revascularization. There were no incidents of stent thrombosis. Six-month angiographic and IVUS follow-up demonstrated an in-stent late lumen loss of 0.08 ± 0.16 mm and a volume obstruction of 3.2 ± 3.0 percent.
Novolimus-Eluting Coronary Stent System With Durable Polymer
Twenty-four-month clinical results from EXCELLA I, the first-in-man study of the novolimus-eluting coronary stent system with a durable polymer, were presented by Dr. Abizaid. At 24 months, the novolimus-eluting coronary stent system demonstrated sustained efficacy and clinical safety with no incidents of stent thrombosis.
Novolimus Eluting Coronary Stent System With Durable Polymer
The EXCELLA II randomized clinical trial completed patient enrollment in the first quarter of 2009. The study enrolled 210 patients in Europe and Asia Pacific. Patients are currently undergoing the nine-month clinical, angiographic, and IVUS follow-up. Data from the trial will be submitted for CE mark approval.
“The performance of Elixir’s DES system during enrollment compared well with some of the market leading stent systems,” said professor Patrick W. Serruys, M.D., Ph.D. of the Thoraxcenter, Erasmus University Hospital, Rotterdam, The Netherlands, principal investigator for the EXCELLA II trial. “I am impressed with Elixir’s ability to successfully conduct the EXCELLA II trial while simultaneously executing the development of multiple generations of product platforms.”
Novolimus and myolimus are macrocyclic lactones in the same family as rapamycin. The macrocyclic lactone drugs represent the most widely utilized drug family for drug-eluting stent applications and have an established safety and efficacy profile.
For more information: www.elixirmedical.com