Genous Bio-engineered R stent beneficial for patients not suitable for long term DAPT

Feb 15 2010

OrbusNeich announced that clinical data presented at the Joint Intervention Meeting (JIM) 2010 in Rome provide further evidence that the company's Genous stent could be a treatment of choice for patients not suitable for long term dual antiplatelet therapy.  The investigator initiated, 50 patient, multicenter study 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.

Presented by Giuseppe M. Sangiorgi, M.D., of the EMO Centro Cuore Columbus and San Raffaele Hospital, Milan, Italy, three-month follow-up data from the Genous in Patients with Reduced Antiplatelet Therapy study show no stent thrombosis of the lesions treated with a Genous Bio-engineered R stent, one case of myocardial infarction, not related to Genous stent implantation, and no sudden cardiac death.

"In our institution we use Genous for patients not suitable for prolonged DAPT (dual antiplatelet therapy) or in whom we feel it may have problems with DAPT compliance," said Professor Sangiorgi.  "For these patients and based on the extremely promising results we have had with Genous stent utilization, I believe that this stent can be the optimal compromise we can offer to our patients in terms of efficacy and safety as compared to bare metal or drug-eluting stents".

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.

Al Novak, OrbusNeich's chairman and CEO, 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."