OrbusNeich Receives Approval For Bio-Engineered R Stent
OrbusNeich has received approval from the Department of Health to market the Genous Bio-engineered R stent in Taiwan.
The Genous stent is coated with an antibody to capture a patient's endothelial progenitor cells (EPCs) circulating in the bloodstream. When attracted to the inner surface of the Genous stent, EPCs have been shown to quickly form a healthy layer of endothelium that minimizes stent restenosis and provides protection against stent thrombosis.
"We are pleased to be able to offer the Genous stent to interventional cardiologists in Taiwan," said Teddy Chien, OrbusNeich's chairman. "The introduction of our pro-healing stent to the Taiwanese market is an important step for our company as we expand our presence in the Asia-Pacific region. Based on our interaction with Taiwanese physicians, we expect strong Genous sales from the outset because of the demand for safe alternatives to drug-eluting stents."
An estimated 20,000 coronary angioplasty procedures will be performed in Taiwan in 2008, 60% of which are expected to involve the use of drug eluting or coated stents.
"We are pleased to have Genous stents become available in Taiwan," said Jui-Sung Hung, M.D., FACC, FAHA, founding President of the Taiwan Society of Cardiovascular Interventions. "Preliminary studies have shown that the use of Genous stents is as safe and effective as TAXUS DES, and more importantly, that the stent thrombosis rate at 12 months is lower with the Genous stent despite one month of dual antiplatelet therapy. Although results of large-scale, randomized control trials are awaited to make more definitive conclusions, I believe Genous will be a good treatment option for patients who cannot undergo long-term dual antiplatelet therapy or patients who have increased risk of thrombotic events."