Interim Analysis of 12-Month Data from e-HEALING Registry Shows Good Safety and Efficacy in Real-World Use of OrbusNeich's Genous(TM) Bio-engineered R...( Additional Data Presentation Shows...),Health

Additional Data Presentation Shows Encouraging 12-Month Outcomes from Single- Center Study Involving Patients with Predominantly Complex Lesions

WASHINGTON, Oct. 14 /PRNewswire/ -- OrbusNeich today announced that an interim analysis of 12-month follow-up data from the global e-HEALING registry show good safety and efficacy in the real-world use of the company's Genous Bio-engineered R stent.

Presented by Professor Robbert de Winter, M.D., Ph.D., of the Academic Medical Center in Amsterdam at the Transcatheter Cardiovascular Therapeutics symposium, TCT 2008, in Washington, D.C., the data from 3,200 patients were a target lesion revascularization (TLR) rate of 5%, a subacute thrombosis (SAT) rate of 0.4%, a late stent thrombosis (LST) rate of 0.3%, and a major adverse cardiac events (MACE) rate of 8.5%.

"The data further support the use of Genous as an alternative to drug- eluting stents, especially in light of the relatively minimal dual- antiplatelet therapy requirements with the stent," said de Winter, a co- principal investigator of the study. "Patient compliance with extended dual- antiplatelet therapy due to cost and other factors such as patients facing imminent non-cardiac surgery are issues that we can address by using Genous."

OrbusNeich's e-HEALING clinical study is a multi-center, worldwide (outside the United States) prospective registry with 5,000 enrolled patients treated with the Genous Bio-engineered R stent. The study protocol recommends that patients receive one month of clopidogrel treatment after the procedure. Clinical follow-up takes place at 30 days, six months and 12 months. The primary endpoint of the registry is target vessel failure at 12 months.

In a related presentation at TCT 2008, de Winter and his colleagues reported data from the Academic Medical Center's single-center, real-world study of the Genous stent in patients with predominantly complex lesions. The data, presented in an electronic pos
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