, June 21
/PRNewswire/ -- OrbusNeich today announced that six-month clinical follow-up data show the safety and efficacy of the combination of pre-dilatation with a paclitaxel drug-eluting balloon (Sequent Please®, B.Braun) followed by implantation of the company's Genous Bio-engineered R stent for the percutaneous treatment of coronary artery stenosis.
In the investigator-initiated, single center, all-comers POTENT (Paclitaxel-eluting ballOon and bio-engineered progeniTor cEll-attracting stainless steel steNT in percutaneous treatment of coronary artery stenosis) registry, 32 percent of patients were diabetic, 86 percent were male, 58 percent had a previous myocardial infarction and the mean age of the study population was 56 years. Of the lesions treated, 46 percent were type B2/C lesions. The patients received a pre-loading of dual antiplatelet therapy (DAPT) at least six hours prior to the percutaneous coronary intervention, and the DAPT was continued for three months. There were no in-hospital or 30 day major adverse cardiac events (MACE) reported. There was one case of late stent thrombosis.
In the six-month clinical follow-up of the 50 patients in the study, the MACE rate was six percent, and the clinical driven target lesion revascularization (TLR) rate was four percent. In an optional nine-month angiographic follow-up of 35 patients, no patients exhibited binary restenosis. Alan Yean Yip Fong, M.D., of the Sarawak General Hospital in Malaysia presented the data during the World Congress of Cardiology Scientific Sessions 2010 in Beijing.
"We are very encouraged by the low MACE and binary restenosis rates, which are comparable to other stenting strategies and demonstrate the potential for combining drug-eluting and pro-healing technologies," said Tiong-Kiam Ong, M.D., of the Sarawak General Hospital in Malaysia and principal investigator of the study. "This therapeutic strategy could be a potent remedy for the dual problem of in-stent restenosis and stent thrombosis."
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.
OrbusNeich's Genous Bio-engineered R stent has been commercially available in over 60 countries since 2005. The Genous stent has been proven as a safe, effective alternative to drug-eluting stents and is supported by data from more than 5,000 patients in company-sponsored clinical studies. There is a growing body of evidence from multiple clinical studies that the Genous stent is effective for patients who are non-responsive to or cannot tolerate long-term dual antiplatelet therapy.
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, R stent, Scoreflex, SafeCut, Sapphire, Sapphire NC, Avita, Avita HP and Lumina. OrbusNeich is headquartered in Hong Kong and has operations in Shenzhen, China; Fort Lauderdale, Fla.; Hoevelaken, The Netherlands; and Tokyo, Japan. 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.