29 May 2018 - - US-based nanocoating technology specialist CeloNova BioSciences, Inc. CeloNova BioSciences, Inc. (CeloNova) has released 1-year clinical trial results from the eCOBRA post-market study of the company's COBRA PzF nanocoated coronary stent system, the company said.
The clinical trial results demonstrated 4.3% target lesion revascularization, 0.3% late stent thrombosis, and 8.6% major adverse cardiovascular events in patients at high risk for bleeding and thrombosis. The average age of patients was 76 years old.
Approximately 30% of patients studied were on oral anticoagulant therapy, and 48% had non–ST-segment elevation myocardial infarction (NSTEMI) or ST-elevation myocardial infarction (STEMI) at clinical presentation.
eCOBRA is a prospective, consecutively enrolled, observational, multi-center, all-comers study comprised of 1,026 patients across 17 centers, including patients with stable angina and acute coronary syndrome.
The study is designed to evaluate the safety and effectiveness of COBRA PzF NCS in patients undergoing treatment of de novo coronary lesions where a drug-eluting stent is typically not indicated.
CeloNova BioSciences is a global medical device company that develops, manufactures and markets a family of products based upon its novel Polyzene-F nanocoating technology.