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