OrbusNeich Presents Positive Results For Genous Bio-Engineered R Stent

OrbusNeich’s interim data from a prospective registry showed good safety in a broad population of patients that underwent primary percutaneous coronary intervention (PCI) and implantation of the company’s Genous Bio-engineered R stent for ST-elevation myocardial infarction (STEMI).

According to OrbusNeich study of 652 consecutive STEMI patients, the rate of major adverse cardiac events was 6.7% and the rate of subacute thrombosis was 1.1% at 30 days follow up.

The interim data were presented at the Transcatheter Therapeutics Conference in San Francisco. 11% of the patients in the study of 652 consecutive STEMI patients were diabetic, 41% had an anterior infarction, 6% were in heart failure, and 6% received an intra-aortic balloon pump. Half of the 23 patients who died were initial survivors of out of hospital cardiac arrest, the company reported.

Jan-Henk Dambrink of the Isala Klinieken, Netherlands, said: “The interim data further support the safety profile of the Genous Bio-engineered R stent in this patient population as we confirm the low subacute stent thrombosis rate seen in several large trials for the Genous Bio-engineered R stent.”

Harry Suryapranata, director of diagram clinical research for department of cardiology, Isala Klinieken, said: “The interim results reflect a similar finding in a study of the Genous stent in 321 STEMI patients conducted at National University Hospital in Singapore. In the Singapore study, the early stent thrombosis rate was 0.9% with no further thrombotic events out to 12 months follow up.”