Clinical study results of Novolimus and Myolimum eluting coronary stent systems released

Sep 24 2009

Elixir Medical Corporation, a developer of products that combine state-of-the-art medical devices with advanced pharmaceuticals, announced today positive results from three multicenter first-in-man studies of Novolimus^TM and Myolimus^TM eluting coronary stent systems with durable and bioabsorbable polymers. Findings were presented at the 21st Annual Transcatheter Cardiovascular Therapeutics (TCT 2009) scientific symposium.

Novolimus Eluting Coronary Stent System with Bioabsorbable Polymer: Nine-Month Clinical and Six-Month Angiographic Results

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. 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 and Angiographic Results

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.

“We are excited about the excellent results of our new bioabsorbable polymer platforms with the Novolimus and Myolimus drugs. We also continue to validate the long-term safety and efficacy of our durable polymer product,” said Motasim Sirhan, chief executive officer of Elixir Medical. “Elixir continues to demonstrate its commitment to developing a broad and innovative portfolio of DES products to better address physician and patient needs.”

Novolimus Eluting Coronary Stent System with Durable Polymer: Twenty-Four-Month Clinical Results

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 Professor Alexandre Abizaid, M.D., Ph.D., of the Institute of Dante Pazzanese de Cardiologia in Sao Paulo, Brazil, at TCT 2009. At twenty-four 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: EXCELLA II Randomized Clinical Trial Update

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.”

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