OrbusNeich's Genous(TM) Stent Associated With Lower Restenosis Rate Compared to Bare Metal Stents in Low-Risk Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) Patients

Results of Randomized JACK-EPC Trial Published in Minerva Cardioangiologica

HONG KONG, May 22, 2013 /PRNewswire/ -- OrbusNeich today announced that the company's Genous Stent is associated with a significantly lower rate of binary restenosis compared to bare metal stents (BMS) in low-risk non-ST-segment elevation acute coronary syndrome (NSTE-ACS) patients at six months. Data from JACK-EPC, an investigator-initiated randomized study, were published in the June issue of Minerva Cardioangiologica.

The binary restenosis rate for the Genous Stent was 13 percent compared to 26.6 percent for BMS at six months. At 12 months, the major adverse cardiac events (MACE) rate for the Genous Stent was 13.3 percent compared to 23.3 percent for BMS, and no stent thrombosis (ST) was observed in either group.

"In this randomized study, we see that the Genous Stent is associated with less neointimal proliferation than a bare metal stent, with significantly lower restenosis and late loss observed," said Wojciech Wojakowski, M.D., Ph.D., of the Medical University of Silesia, Poland, and corresponding author of the publication. "This combined with its favorable safety profile makes Genous an effective alternative to bare metal stents and drug eluting stents for patients with contraindications to dual antiplatelet therapy."

The study investigated the possible correlation between circulating endothelial progenitor cells (EPCs) and restenosis. Previous studies with the Genous Stent as well as drug eluting stents (DES) have shown that lower numbers of these cells might be associated with higher in-stent restenosis (ISR) and ST. The authors noted that the number of circulating EPCs was approximately twofold higher during ACS than at six months and the mobilization of EPCs during acute ischemia was significantly lower in patients who developed restenosis after six months (3 cells/ul versus 4.5 cells/ul).

The investigator-initiated prospective randomized study enrolled 60 patients, randomized 1:1, with NSTE-ACS. The majority in both groups presented with NSTE myocardial infarction (MI): 73.3 percent in the Genous Stent group and 70 percent in the BMS group. Inclusion criteria included a de novo lesion of greater than 70 percent in a native coronary artery with a diameter between 2.5 and 4 mm and a lesion length of less than 30 mm that could be treated with a single stent. Off all lesions treated, 83 percent were type B2/C lesions in the Genous Stent group and 80 percent in the BMS group.

The patients received 80 mg atorvastatin and dual antiplatelet therapy (DAPT) for 12 months. Restenosis was assessed after six months by quantitative coronary angiography. The number of circulating EPCs that were positive for CD34, CD133 and VEGFR2 were measured with fluorescence-activated cell sorting (FACS) prior to percutaneous coronary intervention (PCI) and at six months in both patients with and without restenosis. The study's primary endpoint was binary restenosis.

The primary safety endpoint was the composite of MACE including cardiovascular death, reinfarction and hospitalization for unstable angina at six months.

About the Genous Technology

Genous is OrbusNeich's patented 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 captures EPCs circulating in the blood to the device to form an endothelial layer that provides protection against thrombosis and modulates restenosis.

The Genous Stent, which has been commercially available in more than 60 countries since 2005, has been proven as a safe, effective alternative to drug eluting stents and is supported by data from more than 8,000 patients in clinical studies. There is a growing body of evidence from multiple clinical studies that the Genous Stent is effective for patients that are non-responsive to or cannot tolerate long-term DAPT.

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 Stent, as well as other stents and balloons marketed under the names of Azule™, R stent, Scoreflex™, Sapphire™, Sapphire II and Sapphire NC. Development stage products include the COMBO Dual Therapy Stent™, the world's first dual therapy stent. OrbusNeich is headquartered in Hong Kong and has operations in Shenzhen, China; Fort Lauderdale, Fla.; Hoevelaken, The Netherlands; and Tokyo, Japan. OrbusNeich supplies medical devices to interventional cardiologists in more than 60 countries. For more information, visit www.OrbusNeich.com.

Follow OrbusNeich on Twitter at www.twitter.com/OrbusNeich, and learn more about the company and its innovative technology on OrbusNeich's YouTube Channel: http://www.youtube.com/user/OrbusNeichMedia.