OrbusNeich's Genous stent is safe when accompanied by 10 days of dual antiplatelet therapy (DAPT), according to study data published in the November issue of EuroIntervention.
In a multicenter trial involving 49 enrollees treated with Genous, no patient had died or reached the study's primary endpoint of sudden cardiac death, myocardial infarction or angiographic evidence of stent thrombosis at the three-month follow-up. Study participants received clopidogrel (Plavix) for 10 days, accompanied by lifelong aspirin administration. According to study results, 70% of the patients discontinued clopidogrel 9 to 11 days after stenting.
"The data obtained are encouraging and may justify the launch of a larger study powered to test the possibility to utilize the Genous stent with reduced duration of dual antiplatelet therapy," said principal investigator Prof. Antonio Colombo.
Genous is OrbusNeich's endothelial progenitor cell capture technology that promotes the accelerated natural healing of the vessel wall after the implantation of blood-contact devices. The technology includes an antibody surface coating that attracts EPCs circulating in the blood to form an endothelial layer that provides protection against thrombosis and modulates restenosis.
The Genous stent has been commercially available in more than 60 countries since 2005. Clinical data have shown the stent is effective for patients who are non-responsive to or cannot tolerate long-term DAPT.
The company, which is privately funded, has no partners and is working to expand its market reach into the U.S., David Camp, VP, sales and marketing EMEA, recently told FMD.
- see the OrbusNeich release
- read the more about the study here (sub. req.)