OrbusNeich's clinical data for Genous stent, suggests that it could be a treatment of choice for patients not suitable for long term dual antiplatelet therapy. The clinical data was presented at the Joint Intervention Meeting (JIM) 2010 in Rome.
The company said that the investigator has initiated, 50 patient, multicenter study which evaluated the safety of patients receiving only 10 days dual antiplatelet therapy undergoing stenting with the Genous Bio-engineered R stent. The primary endpoint was the absence of stent thrombosis or any occlusion within three months.
The study population included patients with de novo coronary artery lesions located in the secondary branch vessel. The primary endpoint evaluated the absence of any occlusion and stent thrombosis of the Genous Bio-engineered R stent within three months, including the angiographic evidence of stent occlusion, myocardial infarction in the area of the stented vessel and sudden cardiac death not attributed to other causes.
The three-month follow-up data from the Genous in patients with reduced antiplatelet therapy study, presented by Giuseppe Sangiorgi, of the EMO Centro Cuore Columbus and San Raffaele Hospital, Milan, Italy, demonstrated no stent thrombosis of the lesions treated with a Genous Bio-engineered R stent and no sudden cardiac death.
Al Novak, chairman and CEO of OrbusNeich, said: “Patients who cannot tolerate or take dual antiplatelet therapy, such as patients who have to undergo non-coronary surgery and have to discontinue dual antiplatelet therapy, represent a challenging patient subset. These data demonstrate that such patients can benefit from treatment with the Genous Bio-engineered R stent.”