Reduce Bleeding Risk
Short DAPT Ideal for High Bleeding Risk Patients1
COBRA PzF NanoCoated Coronary Stent (NCS)
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
Exceptional Safety & Efficacy
In the FDA PzF SHIELD IDE trial, COBRA PzF NCS demonstrated:
At 270 Days
0%
Stent Thrombosis2‡
4.6%
TLR2‡
1
Month DAPT1
minimum requirement
Strut Coverage at 14 Days
Faster, Higher Quality Healing Than Market-Leading DES*
COBRA PzF NCS combines a unique cobalt chromium stent platform with the cutting-edge Polyzene-F (PzF) nano-thin polymer.
Polyzene-F NanoCoating:
- Ultra-pure & elastic barrier
- Highly biocompatible
- Thrombo-resistant, anti-inflammatory & rapid healing effects
Strut Coverage at 14 Days
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.§
Shaping the Future of Quality & Safety
In January 2018, CeloNova became one of a handful of companies in the U.S. selected to support advancements in medical device quality and safety through partnership with the FDA’s Case for Quality Voluntary Improvement Program (CFQ VIP).
This program identifies device manufacturers that consistently produce high-quality devices to help better focus FDA resources and promote best practices to help other manufacturers raise their level of quality and safety. Through the program’s partnership, CeloNova aims to further advance quality of care in patients in the U.S.8
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.
* AS DEMONSTRATED IN PRECLINICAL STUDIES.
Correlation between bench testing, animal studies and humans have not been determined.
‡ 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%]
§ For more information about the COBRA REDUCE IDE trial, please visit: clinicaltrials.gov/ct2/show/NCT02594501.
Correlation between bench testing, animal studies and humans have not been determined.
‡ 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%]
§ 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.
- 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. 2018 Oct. Online ahead of print.
- Koppara T, Sakakura K, Pacheco E, et al. Preclinical evaluation of a novel polyphosphazene surface modified stent. International Journal of Cardiology. 2016; 222:217-225.
- Mrowietz C, Franke R, Seyfert U, et al. Haemocompatibility of polymer-coated stainless steel stents as compared to uncoated stents. Clinical Hemorheology and Microcirculation. 2005; 32:89–103.
- Richter G, Stampfl U, Stampfl S, et al. A New Polymer Concept for Coating of Vascular Stents Using PTFEP (poly(bis(trifluoroethoxy)phosphazene) to Reduce Thrombogenicity and Late In-Stent Stenosis. Investigative Radiology. 2005; 40(4):210-218.
- Radeleff B, Thierjung H, Stampfl U, et al. Restenosis of the CYPER-Select, TAXUS-Express, and Polyzene-F NanoCoated Cobalt-Chromium Stents in the Minipig Coronary Artery Model. Cardiovasc
- https://www.fda.gov/medicaldevices/deviceregulationandguidance/medicaldevicequalityandcompliance/ucm378185.htm