144 0 Kommentare CeloNova Announces Late-Breaking Evidence from First-Ever Randomized Controlled Trial Evaluating 14-Days DAPT in Complex Patients at High Bleeding Risk Following PCI - Seite 3

Over 25,000 patients worldwide have been treated to date with COBRA PzF NCS. The novel stent has been extensively evaluated over the course of 10 years and 10 clinical trials in roughly 3,300 patients worldwide, consistently demonstrating excellent results with low TLR and low ST with short DAPT regimens in a real-world patient population.²

About CeloNova BioSciences, Inc.

CeloNova BioSciences, Inc. is a global medical device company that develops, manufactures and markets a family of products based upon its novel Polyzene-F nanocoating technology. The next generation nanocoating is the result of years of rigorous scientific research and engineering and has been extensively published in numerous academic articles to date. For additional information about CeloNova, please visit our website at www.celonova.com.

The COBRA PzF NanoCoated Coronary Stent System is indicated for improving coronary luminal diameter in patients, including patients with diabetes mellitus, with symptomatic ischemic heart disease due to de novo lesions in native coronary arteries. The COBRA PzF NanoCoated stent is intended for use in patients eligible for percutaneous transluminal coronary angioplasty (PTCA) with reference vessel diameter (RVD) of 2.5-4.0mm and lesion length of ≤24mm. Click here for IMPORTANT SAFETY INFORMATION. Rx only.

The COBRA PzF NanoCoated Coronary Stent is not currently approved or indicated for high bleeding risk patients with 14-day DAPT.

*myocardial infarction, definite and probable stent thrombosis, or ischemic stroke
† AS DEMONSTRATED IN PRECLINICAL STUDIES. Correlation between bench testing, animal studies and humans have not been determined.

1. Jinnouchi H Mori H, et al. Thromboresistance and Functional Healing in the COBRA PzF Stent versus Competitor DES: Implications for Dual Anti-Platelet Therapy. EuroIntervention. 2019 July 20;15(4):e342-e353. 2. ATLANTA FIM (n=55) TLR 3.6%, LST 0%; ATLANTA 2 Registry (n=300) TLR 6.5%, LST 0%; REVEAL OCT (n=34) Strut Coverage: PzF-97%, DES-90%, BMS-96%; ATLANTA FME Registry (n=500) TLR 4.3%, LST 0%; MAILLARD IIT (n=100) TLR 5%, ST 0%; UMEÅ IIT (n=103) TLR 3.9%, ST 0%.