Data from TEN 10 years cumulaTive Experience on CarbosteNt trials

Since its introduction in 1998 Carbostent has demonstrated superior and consistent clinical and angiographic results, achieved by maintaining its unique technical characteristics throughout the evolution of the product. Carbostent makes use of innovative close cell geometry, conceived to avoid stress concentration and elastic distortion and to allow homogeneous stent expansion and plaque coverage.

The mirror-like surface polishing treatment derived from heart valve technology gives the stent rounded edges that optimise fluid dynamics and minimise risk of trauma to the vessel wall. Carbostent has an integral and permanent coating (< 0.5 m) of turbostratic carbon (Carbofilm™) that renders the surface thromboresistant and enhances stent biocompatibility. The Carbofilm™ coating produces a pure carbon interface between the stent and blood, preventing the release of allergenic metal ions such as nickel, chromium and molybdenum from the stent surface. With over 10 years clinical use and greater than 7,000 patients treated in a range of clinical studies, Carbostent has demonstrated excellent clinical and angiographic outcomes, including high procedural success (99.0%) and lesion success (99.3%.). It has also demonstrated a very low incidence of cardiac events in a range of patient populations including high risk patients (diabetes, AMI, multi vessel disease), with a freedom from MACE of 87.8% for death, 98.9% for MI, and 88.5% for TLR up to 24 months follow up. Superior device efficacy in BMS with low binary restenosis rate of 13.4% and Late Lumen Loss of 0.63mm.

The strong safety profile of the Carbofilm™ coated platform has been confirmed by 0.2% and 0.3% acute and subacute thrombosis rates and 0% late thrombosis rate in a large patient population.