FORT LAUDERDALE, Fla., Dec. 1 /PRNewswire/ -- OrbusNeich today announced the initiation of patient enrollment in the randomized clinical trial of the Combo Bio-engineered Sirolimus Eluting Stent (Combo Stent).
The study population will consist of patients with symptomatic, ischemic heart disease due to a stenotic lesion located in a native coronary artery. The primary endpoint is in-stent late lumen loss of the Combo Stent compared to DES at nine months post-procedure. Secondary endpoints include all-cause and cardiac mortality, myocardial infarction, Major Adverse Cardiac Event (MACE) and stent thrombosis rates at 30 days, nine months and one through five years, as well as clinically driven Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR) and Target Lesion Failure (TLF) rates at the same follow-up times.
The Combo Stent is designed to combine the pro-healing technology used in OrbusNeich’s Genous(TM) Bio-engineered R stent(TM) for rapid endothelial coverage with an abluminal sirolimus drug elution for the control of neointimal proliferation. The low dose sirolimus elution is accomplished through the use of the SynBiosys(TM) biodegradable polymer matrix from SurModics, Inc. .
“The Combo Stent has demonstrated significantly lower neointimal hyperplasia, improved endothelial coverage relative to commercially available drug-eluting stents and lower presence of inflammation and foreign body reaction in multiple pre-clinical studies,” said Renu Virmani, M.D., president and medical director of CVPath Institute, Inc. “Furthermore, I have long believed that the next generation of stents can benefit from biodegradable polymers. The data I’ve seen on the SynBiosys biodegradable polymer suggest it is very biocompatible with low inflammatory scores that could also result in improved endothelialization.”
About Genous
Genous is OrbusNeich’s patented endothelial progenitor cell (EPC) capture technology that promotes the accelerated natural healing of the vessel wall after the implantation of blood-contact devices such as stents. The technology consists of an antibody surface coating that attracts EPCs circulating in the blood to the device to form an endothelial layer that provides protection against thrombosis and modulates restenosis.
About OrbusNeich
OrbusNeich is a global company that designs, develops, manufactures and markets innovative medical devices for the treatment of vascular diseases. Current products are the world’s first pro-healing stent, the Genous Bio-engineered R stent, as well as stents, balloons and guiding catheters marketed under the names of Blazer(TM), R stent, Scoreflex(TM), SafeCut(TM), Sapphire(TM), Sapphire NC, Avita(TM), Avita HP and Lumina(TM). OrbusNeich is headquartered in Hong Kong and has operations in Fort Lauderdale, Fla.; Hoevelaken, The Netherlands; Tokyo, Japan; and Shenzhen, China. OrbusNeich, which has provided medical devices to physicians through its predecessor companies since 1979, supplies products today to interventional cardiologists in more than 60 countries. For more information, visit www.OrbusNeich.com.
CONTACT: David Schull, david.schull@russopartnersllc.com, or Martina
Schwarzkopf, Ph.D., martina.schwarzkopf@russopartnersllc.com, Russo
Partners, +1-212-845-4271 (office), +1-858-717-2310 (mobile); or David
Kujawa, OrbusNeich, +1-954-730-0711 (office), +1-305-733-7216 (mobile),
dkujawa@orbusneich.com
Web site: http://www.OrbusNeich.com/