News | December 04, 2008

CeloNova Commercialized Coronary Stent with NanoThin Polyzene-F Coating

December 5, 2008 - CeloNova BioSciences Inc. said this week it expanded the areas in which it is commercializing the CATANIA Coronary Stent System with NanoThin Polyzene-F, a stent system that has not had any stent thrombosis in clinical studies.

It is CE marked and available for purchase throughout Europe and now some Middle Eastern countries. CeloNova has received regulatory approval to increase the shelf life for the stent from two years to three years.

The CATANIA Polyzene-F surface treatment is an inorganic polymer that confers superior biocompatibility and lubricity to the substrates it coats. The company said the Polyzene-F treated surface is anti-inflammatory, promotes quick and complete vessel healing, reduces perioperative and post-procedural platelet activation, and helps to prevent tissue reactions that lead to restenosis.

“After having evaluated the Polyzene-F coating many years ago, it is interesting to see this concept coming back with experimental and initial clinical data quite encouraging toward prevention of stent thrombosis,” said Antonio Colombo, M.D., director of the cardiac catheterization laboratory at Columbus Hospital and chief of invasive cardiology at San Raffaele Hospital,
both in Milan, Italy, who recently added the CATANIA stent to his practice.

The one-year data for the first-in-man (FIM) presented at the recent Transcatheter Cardiovascular Therapeutics (TCT) conference shows that at 12 months, in an unusually complex FIM patient population, the results showed zero percent stent thrombosis (Academic Research Consortium, or ARC-defined), death, myocardial infarction, stroke, or coronary artery bypass graft. Target lesion revascularization was 10.9 percent (only 3.6 percent clinically driven, 7.3 percent non-clinically driven), with a binary restenosis rate of 6.8 percent (five of 74 lesions analyzed at twelve months). Of note, all patients stopped dual anti-platelet therapy after 30 days, but continued aspirin (100 mg/d) throughout the 12-month period.

The acute angiographic and procedural success rate in the ATLANTA Trial was 100 percent. Independent core laboratories analyzed quantitative coronary angiography and intravascular ultrasound (IVUS) data for all patients immediately after stent implantation and at six-month follow-up.

Further analysis of 1,904 cross sections (19,028 struts) by investigators using optimal coherence tomography at baseline and again at six-month follow-up in a subset of 15 randomly selected patients revealed complete endothelialization and 99.5 percent stent strut coverage.

For more information: www.celonova.com

Related Content

The Biotronik Osiro is an ultra thin strut, sirolimus-eluting stent. #TCT2018

The Biotronik Osiro is an ultra thin strut, sirolimus-eluting stent.

News | Stents | October 04, 2018
October 4, 2018 – Investigators unveiled clinical data from the independent BIONYX and SORT OUT IX all-comers trials
FDA Approves Biotronik's PK Papyrus Stent for Coronary Perforations
Technology | Stents | September 27, 2018
September 27, 2018 — Biotronik recently announced U.S.
Videos | Stents | September 11, 2018
This is an animation showing how the dedicated bifurcation stent developed by Advanced Bifurcation Systems (ABS) is d
Elixir Medical Corporation Unveils Transformational DynamX Stent Featuring Adaptive Segments that Uncage the Stented Artery
News | Stents | January 25, 2018
January 25, 2018 – Elixir Medical Corporation, a leader in the development of breakthrough adaptive remodeling techno
The TIDES-ACS results show us that the Optimax stent is noninferior in patients with acute coronary syndrome compared to Synergy.

The presentation of the ESC late-breaker TIDES-ACS results show us that the Optimax stent is noninferior in patients with acute coronary syndrome compared to Synergy.

News | Stents | November 24, 2017
November 24, 2017 – During a late-breaking session at the European Society of Cardiology (ESC) 2017 meeting, presente
News | Stents | November 10, 2017
Cordis, a Cardinal Health company, recently unveiled a comprehensive interventional cardiology portfolio, which now...
OCT comparison between the Combo vs. Xience stents in the HARMONEE study.

OCT comparison between the Combo vs. Xience stents in the HARMONEE study.

Feature | Stents | November 08, 2017
November 8, 2017 – New results from the HARMONEE Japan/U.S.
FDA Approves COBRA REDUCE Trial of 14-Day DAPT With CeloNova Stent
News | Stents | October 27, 2017
CeloNova BioSciences Inc. announced the U.S. Food and Drug Administration (FDA) approved expansion of CeloNova's...
CeloNova Cobra Pzf stent
Technology | Stents | March 02, 2017
March 2, 2017 — The U.S. Food and Drug Administration (FDA) cleared CeloNova BioSciences Inc.
OCT, intravascular imaging, stent, good stent apposition on vessel wall, TRANSFORM-OCT study

An OCT image showing good stent strut apposition against the vessel wall.

News | Stents | January 13, 2017
January 13, 2017 — Results from TRANSFORM-OCT, a prospective, randomized trial using optical coherence tomography (OC
Overlay Init