Reduce Bleeding Risk
Short DAPT Ideal for High Bleeding Risk Patients1
Exceptional Long-Term Safety & Efficacy in Complex Patients
In the FDA PzF SHIELD IDE trial, the COBRA PzF NanoCoated Coronary Stent (NCS) demonstrated exceptional 0% stent thrombosis* and low ID-TLR at five-years in highly complex patients undergoing PCI.3
ReThink Short DAPT
The world’s first and only non drug-eluting, nanocoated coronary stent that allows physicians to safely and effectively treat patients with short, 1-month DAPT.1
Polyzene-F: A Distinctly Superior Nanocoating
COBRA PzF NCS is coated with Polyzene-F (PzF), a biomimetic, nano-thin surface coating that acts as a barrier between the device, intimal surface, and circulating elements in the blood.
Learn more about how CeloNova’s proprietary process renders PzF distinctly superior within its polymer class:
Individualized Antiplatelet Therapy (DAPT)
Finding the right DAPT balance is critical to reducing complications. COBRA PzF NCS is a new choice of stent that allows physicians an individualized approach to safely and effectively treat their patients who may benefit from a minimum of 1-month DAPT2 and is being studied with even shorter, 14-day DAPT in the COBRA REDUCE IDE trial.§
San Antonio, TX – June 1, 2020
CeloNova Announces Enrollment Completion of World’s First Randomized Control, 14-Day DAPT Trial
The COBRA REDUCE randomized control trial is a first-of-its-kind study designed to evaluate ultra-short DAPT in PCI patients at high bleeding risk with COBRA PzF NCS with 14-day DAPT compared to drug-eluting stents with 3 or 6 months DAPT.
† Stent thrombosis defined as ARC Definite, Probable and Possible; stent thrombosis and cTLR assessed at 270 days [95% Confidence Interval ST, 0.00%, 1.29%, cTLR, 2.45%, 7.67%]
‡ AS DEMONSTRATED IN PRECLINICAL STUDIES. Correlation between bench testing, animal studies and humans have not been determined.
§ For more information about the COBRA REDUCE IDE trial, please visit: clinicaltrials.gov/ct2/show/NCT02594501.
- 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.
- 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.
- PzF SHIELD IDE Trial, 5-Year results, data on file at CeloNova BioSciences, Inc. Clinicaltrials.gov/ct2/show/NCT01925794.
- Jinnouchi H, Mori H, Cheng Q, et al. Thromboresistance and Functional Healing in the COBRA PzF Stent versus Competitor DES: Implications for Dual Anti-Platelet Therapy. EuroIntervention. July 19, 2019;15(4):e342-e353.