News | October 16, 2008

Elixir Medical Has Positive First-In-Man Results from Three New Coronary DES

October 17, 2008 - Elixir Medical Corp. today announced results from three multicenter first-in-man studies of Novolimus and Myolimus eluting coronary stent systems at the 20th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C.

Twelve-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 Alexandre Abizaid, M.D., Ph.D., of the Institute of Dante Pazzanese de Cardiologia in Sao Paulo, Brazil. He said at the 12-month clinical follow-up, the Novolimus eluting coronary stent system demonstrated sustained efficacy and clinical safety with no MACE events or incidents of stent thrombosis. Eight-month angiographic and IVUS follow-up demonstrated an in-stent late lumen loss of 0.31 ± 0.25 mm and a volume obstruction of 6 ± 0.36 percent.

Nine-month clinical and six month 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 durable polymer were presented at TCT 2008 by Wolfgang Rutsch, M.D., Ph.D. of Charite Campus Mitte, Berlin, Germany. At the nine-month clinical follow-up, one patient experienced a non Q-wave myocardial infarction. Six-month angiographic and IVUS follow-up demonstrated an in-stent late lumen loss of 0.15 ± 0.11 mm and a volume obstruction of 1.4 ± 1.2 percent. There were no incidents of stent thrombosis.

Six-month clinical, angiographic and IVUS results using the Myolimus stent were presented by Dr. John Ormiston, MBChB, of Auckland City Hospital, Auckland, New Zealand. At the six-month clinical follow up, one patient experienced a non Q-wave myocardial infarction and one patient experienced a target lesion revascularization. Six-month angiographic and IVUS results from the first cohort of 15 patients demonstrated an in-stent late lumen loss of 0.37 ± 0.44 mm and a volume obstruction of 14.2 ± 7.7 percent. There were no incidents of stent thrombosis.

The stents will be further tested in the Novolimus EXCELLA II Randomized Clinical Trial scheduled to commence this quarter, said Patrick W. Serruys, M.D., Ph.D., of the Thoraxcenter, Erasmus University Hospital, Rotterdam, the Netherlands.

For more information: www.elixirmedical.com

Related Content

Medtronic Announces Global Resolute Onyx DES One-Month DAPT Study
News | Antiplatelet and Anticoagulation Therapies| August 18, 2017
Medtronic plc announced a global randomized clinical trial that will evaluate one-month dual antiplatelet therapy (DAPT...
Bivalirudin exhibited an improvement in 30-day all-cause mortality when injected post PCI.
News | Antiplatelet and Anticoagulation Therapies| August 16, 2017
August 16, 2017 — A study has examined the efficacies of various post-percutaneous coronary intervention (PCI) bivali
ESC 2017 late breaking trial hot line study presentations.
News | Clinical Study| August 16, 2017
Aug. 16, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking Clinic
News | Drug-Eluting Balloons| August 15, 2017
Surmodics Inc. announced receipt of an investigational device exemption (IDE) from the U.S. Food and Drug...
The Vascular Dynamics MobiusHD device enhances the carotid baroreceptors to reduce resistant hypertension.
News | Hypertension| August 15, 2017
Aug. 15, 2017 — The U.S. Food and Drug Administration (FDA) has approved the Vascular Dynamics Inc.
Abbott Initiates First Clinical Trial of Clip-Based Tricuspid Repair System
News | Heart Valve Technology| August 09, 2017
Abbott announced that the first patient has been enrolled in a clinical study to evaluate a minimally invasive clip-...
Three New Atrial Fibrillation Studies to Feature HeartLight Endoscopic Ablation System
News | Ablation Systems| August 07, 2017
CardioFocus Inc. announced that its HeartLight Endoscopic Ablation System is being featured in three new major clinical...
Registry Identifies Early Onset of Heart Failure and Lack of Defibrillators in Asia
News | Heart Failure| August 03, 2017
August 3, 2017 — The Asian Pacific Society of Cardiology (ASPC) held its first-ever late-breaking...
Overlay Init