Exceptional Clinical Results

3,300 Patients Studied Worldwide

PzF SHIELD IDE Trial

Proven Safe & Effective

PzF SHIELD is a single-arm, non-randomized, prospective clinical trial that met its primary endpoint of TVF and the secondary endpoint of angiographic late lumen loss at 270 days.

Published in JACC
At 270 Days

0%

Stent Thrombosis2

4.6%

TLR2

1

Month DAPT3
minimum requirement

N: 296 | US & Europe Multicenter | Mean Age: 66 | Diabetes: 34%
AFIB: 12% | RVD: 2.7mm
At 270 Days

0%

Stent Thrombosis2

4.6%

TLR2

1

Month DAPT3
minimum requirement

N: 296 | US & Europe Multicenter | Mean Age: 66 | Diabetes: 34% | AFIB: 12% | RVD: 2.7mm
Published in JACC

eCOBRA All-Comers Study

Patients at High Risk for Bleeding & Thrombosis 

eCOBRA is a prospective, consecutively enrolled, observational, multi-center, all-comers study that demonstrated positive outcomes in patients at high risk of bleeding and stent thrombosis in a real-world setting.

0.3%

Stent Thrombosis4

4.3%

TLR4

~30% OAC
  22% STEMI
  56% ACS

High Risk Patients4

N: 940 | France Multicenter | Mean Age: 76

Discussion of the Clinical Evaluation of
COBRA PzF NanoCoated Coronary Stent (NCS)

Polyzene-F (PzF) NanoCoated Stent Clinical Program1

CeloNova BioSciences’ comprehensive clinical program consists of approximately 3,300 patients worldwide, including over 2,400 being evaluated with the 2nd generation PzF NanoCoated stent, COBRA PzF NCS.

Read Publications

COBRA REDUCE Trial: 14-Day DAPT in High Bleeding Risk Patients

Cobra Reduce Clinical Trial

COBRA REDUCE is the world’s first and only randomized, global study designed to assess clinical outcomes in high bleeding risk patients with 14-day DAPT as compared to FDA-approved DES with 3 or 6-months of DAPT.§

For additional information visit clinicaltrials.gov

Cobra Reduce Clinical Trial
Now Enrolling

Publications

CeloNova BioScience’s first and second generation coronary stents with novel Polyzene-F nanocoating have been studied in numerous peer reviewed journals. Learn more in the publications below:


Mark C. Bates, et. al.

Translational Research and Early Favorable Clinical Results of a Novel Polyphosphazene (Polyzene-F) Nanocoating. Regenerative Engineering and Translational Medicine. March 14, 2019.


Mori H., Jinnouchi H., et. al.

A new category stent with novel polyphosphazene surface modification. Future Cardiology (Epub ahead of print). Published Online: 27 Mar 2018 https://doi.org/10.2217/fca-2017-0103


Styllou P, Silber S.

A case report of the new Polyzene™-F COBRA PzF™ Nanocoated Coronary Stent System (NCS): Addressing an unmet clinical need. Cardiovascular Revascularization Medicine. 2016 April-May;17(3):209-211.


Cutlip DE, Garratt KN, Novack V, et. al

9-Month Clinical and Angiographic Outcomes of the COBRA Polyzene-F NanoCoated Coronary Stent System. JACC Cardiovascular Interventions. 2017 Jan 23;10(2):160-167.


Tamburino C, La Manna A, Di Salvo ME, et al.

First-in-man 1-year clinical outcomes of the CATANIA Coronary Stent System with Nanothin Polyzene-F in De Novo Native Coronary Artery Lesions: The ATLANTA (Assessment of The Latest Non-Thrombogenic Angioplasty stent) Trial. JACC Cardiovascular Interventions. 2009; 2:197-204.


Tamburino C, Capodanno D, Di Salvo ME, et al.

Safety and effectiveness of the Catania Polyzene-F coated stent in real world clinical practice: 12-month results from the ATLANTA 2 registry. EuroIntervention. 2012; 7:1062-1068.


La Manna A, Capodanno D, Cera M, Di Salvo ME, et al.

Optical Coherence Tomographic Results at Six-Month Follow-Up Evaluation of the CATANIA Coronary Stent System with NanoThin Polyzene-F Surface Modification (from the Assessment of the Latest Non-Thrombogenic Angioplasty Stent [ATLANTA] Trial). American Journal of Cardiology. 2009; 103:1551-1555.


Tamburino C, Giacoppo D, Capodanno D.

The Rapid Evaluation of Vessel Healing after Angioplasty (REVEAL) trial. Interventional Cardiology. 2011; 3:451-460.


Browse All Publications
‡ 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.
*Including over 2,400 being evaluated with the 2nd generation PzF NanoCoated stent, COBRA PzF NCS
  1. 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%.
  2. 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.
  3. 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.
  4. Andersson J, Nilsson J, Strandh A. Clinical experiences from nanothin Polyzene-F coated coronary stents in a high-risk population [abstract]. In: EuroPCR 2016; 2016 May 17-20; Paris, France. Retrieved from https://www.pcronline.com/eurointervention/AbstractsEuroPCR2016_issue/abstracts-europcr-2016/Euro16A-POS0323/clinical-experiences-from-nanothin-polyzene-f-coatedcoronary-stents-in-a-high-risk-population.html