SAN ANTONIO, May 13, 2021 /PRNewswire/ -- CeloNova BioSciences, Inc. (CeloNova), a global medical device company that offers a family of innovative products based upon its proprietary Polyzene™-F nanocoating technology, today announced its flagship COBRA PzF NanoCoated Coronary Stent (NCS) achieved exceptional long-term ischemic safety of 0% definite and probable stent thrombosis (ST) and low ischemia-driven target lesion revascularization (ID-TLR) of 7.8% for its non-angiographic cohort at five years.1 Results conclude the company's global, multicenter PzF SHIELD IDE clinical trial of highly complex patients undergoing percutaneous coronary intervention (PCI). The study met its primary and secondary endpoints at 9 months, demonstrating an excellent safety profile with 0% ST and low, 4.6% ID-TLR with a minimum of 1-month DAPT therapy and was the basis for the stent's FDA approval in 2017.2,3
"It's truly remarkable to have a stent achieve complete protection from ischemic events with 0% definite and probable stent thrombosis at both the 9-month and 5-year follow-up periods," said Prof. Sigmund Silber, MD, PhD, Professor of Medicine FESC, FACC, FAHA at Practice in the ISAR Heart Center in Munich, Germany. "The results are particularly noteworthy given the highly complex nature of the patients who were studied. It offers valuable insight into COBRA's performance as coronary artery disease progresses over time."
A total of 296 patients with de novo coronary artery lesions from 35 centers across the U.S. and Europe received treatment with COBRA PzF NCS in the single-arm, non-randomized trial. The study's population included elderly patients (66.5 average age) with co-morbidities including diabetes (33.7%), atrial fibrillation (12.2%) and those with highly complex lesions (72% with type B2 or C lesions).
"These results reinforce the unique thromboresistant, anti-inflammatory and rapid healing properties of COBRA's proprietary Polyzene-F coating, which has been consistently demonstrated in my pre-clinical research at CVPath since 2012," stated Aloke Finn, MD, Medical Director and Chief Scientific Officer at CVPath and Associate Professor of Medicine at the University of Maryland. "The results of the SHIELD trial show that there is a unique advantage of the Polyzene-F coating in allowing a stent to heal quickly and in a functional way without the need for antiproliferative drug elution. I believe COBRA will continue to play an important role in delivering safety and efficacy in real-world clinical practice over time."
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 exceptionally low ST, low TLR and with short DAPT regimens in a real-world patient population.4
"We are extremely pleased that COBRA PzF NCS continues to strike the perfect balance between safety and efficacy and proud of its durable long-term clinical outcomes," stated Carl St. Bernard, President and Chief Executive Officer of CeloNova. "We look forward to continuing to evaluate its performance with ultra-short DAPT in the highly underserved patient population at high risk for bleeding."
COBRA PzF NCS is currently being evaluated with 14-days DAPT in high bleeding risk patients in the COBRA REDUCE clinical trial, the world's first and only randomized, global 14-day DAPT study. The study's six-month results, which were announced at TCT 2020, demonstrated strong ischemic performance of 0.6% definite and probable ST with just 14 days of DAPT with COBRA PzF NCS.† The company anticipates release of the study's 12-month results later this year.
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.
* AS DEMONSTRATED IN PRECLINICAL STUDIES. Correlation between bench testing, animal studies and humans have not been determined.
† The COBRA PzF NanoCoated Coronary Stent is not currently approved or indicated for high bleeding risk patients with 14-day DAPT.
- PzF SHIELD IDE Trial, 5-Year results, data on file at CeloNova BioSciences, Inc. Clinicaltrials.gov/ct2/show/NCT01925794.
- Cutlip D, Garrat K, Novack V, et al. 9-Month Clinical and Angiographic Outcomes of the COBRA Polyzene-F NanoCoated Coronary Stent System. JACC Cardiovasc Interv. 2017;10(2):160-167.
- Levine G, Bates E, Bittl J, et al. 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients with Coronary Artery Disease. Circulation. 2016;134(10):e123-55.
- 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%; SHIELD at 5 Years (n=296) TLR 7.8% (non-angio subgroup), ST 0% (def/prob). 12% ID-TLR (angio + non angio subgroup).
SOURCE CeloNova BioSciences, Inc.