Source: EuroIntervention Journal, October 2006
The information was published in the French Government Journal "Journal Officiel de la République Française" in april 2006. Hexacath is proud to make available to physicians and patients around the world its unique patented Titanium-Nitride-Oxide technology which has been proven to significantly reduce restenosis and MACE (Major Adverse Cardiac Event) at follow up versus Bare Metal Stents.
This recognition by one of the most revered Health Autority in Europe comes after several years of Research on the Titanium-Nitride-Oxide benefits at the level of Cells, Animals and finally Humans. Several international studies on cells have shown that Titanium-Nitride-Oxide bio-active coating not only inhibits platelet aggregation as well as fibrin growth which are both involved in the restenosis process, but also promotes re-endothelialisation after stenting versus stainless steel. Animal studies have shown that Titanium-Nitride-Oxide Bio Active Stent reduces in-stent neointimal formation by 44 to 47 % versus Bare Metal Stents. Randomized studies have proven that Titanium-Nitride-Oxide Bio Active Stents reduce restenosis by 55 % and MACE by 74% versus Bare Metal Stents.
Furthermore, various clinical studies conducted in different countries during the past three years (Spain, Italy, Finland, Israel, Switzerland) enrolling more than 1000 patients in total have shown that Titanium-Nitride-Oxide Bio Active Stents were safe and effective with similar MACE (Major Adverse Cardiac Events) at follow up in comparison with Drug Eluting Stents (reduced rate of new revascularization and even lower rates of Death and AMI).
Finally, TITAN2 BAS (Bio Active Stent) coated with Titanium-Nitride-Oxide is not impeding the natural process of re-endothelialisation after PCI, therefore patients treated with TITAN2 BAS (Bio Active Stent) do not require more than 1 month of dual antiplatelet treatment which is minimizing the patient exposure to aggressive long term dual antiplatelet treatments that may induce additional bleeding risks or side effects linked to these drugs. Moreover, patients treated with TITAN2 BAS (Bio Active Stent), unlike DES (Drug Eluting Stent), can undergo surgery as early as one month after PCI as there is no need for longer Clopidogrel treatment than with BMS.
With TITAN2 BAS (Bio Active Stent) now available in more and more countries throughout the world physicians have an ideal alternative to DES (Drug Eluting Stent) to reduce restenosis and MACE without compromising the patient safety. Made of stainless steel coated with Titanium-Nitride-Oxide, TITAN2 BAS (Bio Active Stent) provides also unique biomechanical properties such as extremely low profile and superior flexibility making TITAN2 BAS (Bio Active Stent) one of the most deliverable stents currently available on the market.
Hexacath is an independent French company founded in 1992 in the Paris area to develop, manufacture and distribute medical devices for coronary and peripheral applications. The company is present in more than 25 countries and has recently obtained the agreement for sale in Canada. Hexacath philosophy is to develop innovative products with unique features to help treat safely patients with coronary or peripheral artery diseases.
About stent reimbursement in France : Reimbursement is granted by the Highest Health Authority Agency according to the clinical benefits that each stent provides to the patient ranking between the highest Level (I) and the lowest Level (V). Today in France, all coronary stents have received the lowest grade (Level V) except for three DES (Cypher , Taxus and Endeavor) that have received a level II reimbursement and except for TITAN2 as the first Bio-Active-Stent (B.A.S) that has received a level III reimbursement.