August 14, 2020
Ten-Year Safety and Efficacy Data Published for Translumina's Vivo Isar Polymer-Free DES
August 14, 2020—Translumina announced that 10-year follow-up safety and efficacy data from the ISAR TEST-5 study of the company’s Vivo Isar dual-drug polymer-free drug-eluting stent (DES) were published by Professor Sebastian Kufner, MD, et al in Journal of the American College of Cardiology (2020;76:146-158). Prof. Kufner presented the 10-year ISAR TEST-5 data at the American Heart Association scientific sessions 2019, held last November.
According to the company, the Vivo Isar uses Probucol, an antioxidant and lipid-lowering drug, as a carrier for releasing sirolimus, thus creating a polymer-free DES platform. The ISAR-TEST-5 trial compared Translumina’s Vivo Isar DES with the Endeavour Resolute DES (Medtronic).
Adnan Kastrati, MD, who is Director, Cardiac Catheterization Lab, at the German Heart Center in Munich, Germany, serves as the lead investigator of the trial. In Translumina’s announcement, Dr. Kastrati commented, “The 10-year result of Vivo Isar is a major breakthrough in DES technology as it proves that synthetic polymers can be removed from a DES without compromising the efficacy of the DES. The excellent safety profile, proven over 10 years, also reassures the cardiologist for the longevity of the clinical results for treating complex coronary artery disease in high-risk patient subsets. This DES technology carries the great potential of significantly shortening the duration of dual-antiplatelet therapy.”
Based in New Delhi, India, and Hechingen, Germany, Translumina is a global developer and manufacturer of cardiovascular medical devices used in interventional cardiology and minimally invasive surgery.
The company noted that in 2018, the 10-year data from ISAR-TEST 4 trial of Translumina's Yukon Choice PC biodegradable polymer DES compared with the Xience DES (Abbott) were presented at the American Heart Association scientific sessions held November 10-11 in Chicago, Illinois, and simultaneously published by Prof. Kufner, et al in Circulation (2019;139:325-333). Also, in 2019, Everstone Capital invested in Translumina to further strengthen the company’s research & development pipeline, scale its manufacturing operations, and expand its global footprint.