BIOTRONIK has just released results of a multi-center study evaluating the effectiveness of the firm’s new PRO-Kinetic coronary stent. The device, now available only in Europe, is known for its cobalt chromium metal alloy composition, thin struts, high deliverability, and a proprietary silicon carbide PROBIO® coating, that was designed to reduce the thrombogenic properties of metal stents, while facilitating complete endothelialization.Here’s what the company is reporting:
Twelve coronary intervention centers in Belgium, the Netherlands and Germany are participating in the study which has enrolled 202 patients, 100 patients with 6-month angiographic follow up. These interim results include 74 patients, with 57 patients receiving angiographic follow up. Total MACE (comprised of cardiac death, MI, TLR and CABG) was 8.1%, all of which was made up of TLR. There was no incidence of cardiac death, MI or stent thrombosis. Six-month QCA data showed in-stent Late Lumen Loss(LLL) of 0.65 mm. Procedural, lesion and device success was 100%.“This study shows that PRO-Kinetic is the ideal stent for patients who do not necessarily require a drug-eluting stent,” said Vice President of Sales and Marketing, Alain Aimonetti. “With a late lumen loss of 0.65 mm, these results rival some drug-eluting stents. We believe that the combination of our stent design, thin strut thickness and the PROBIO® passive coating are responsible for such excellent outcomes and we look forward to confirming the results when the full 202 patient results come in.”The PRO-Kinetic stent combines an innovative design of ultra-thin cobalt chromium struts with PROBIO®, a silicone carbide layer that improves the stent’s heamocompatibility and biocompatibility, to obtain its excellent clinical results. PRO-Kinetic is indicated for the treatment of coronary arteries of 2.0 to 5.0 mm in diameter.
Press release: BIOTRONIK announces positive interim results for its PRO-Kinetic Coronary Stent clinical study…Device page: PRO-Kinetic…Here’s a link to recent presentation (.pdf) about the PRO-Kinetic Stent given at EuroPCR 2008…
