Buelach, Switzerland. BIOTRONIK welcomed the interim results from the prospective, multicenter, single-arm study that demonstrates efficacy and safety of BIOTRONIK’s PRO-Kinetic Coronary Stent System. An analysis of nearly half of the patients showed excellent device performance; very promising MACE, TVR and TVF rates; and no stent thrombosis. The interim results were presented at the annual SOLACI Meeting in Cancun, Mexico.
The Multi BENE (MULTIcentric BElgium/NEtherlands PRO-Kinetic Safety and Efficacy) study was initiated to evaluate the efficacy and safety of the PRO-Kinetic Cobalt Chromium Coronary Stent System. Paul Vermeersch, M.D., from the Antwerp Cardiovascular Institute Middelheim at AZ Middelheim, Antwerp, Belgium, is the co-primary investigator, together with Maarten J. Suttorp, M.D. from St. Antonius Ziekenhuis, Nieuwegein, The Netherlands.
“The interim results we’ve seen so far from this study have been very promising, especially with the high degree of device, lesion and procedural success. ,” said Dr. Vermeersch. “By the time we complete all the patient follow ups, I expect the results to mirror the excellent clinical outcomes we’ve already seen in our hospital.”
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.
The full 1-year results are scheduled to be presented in Q2/2009.
About BIOTRONIK GmbH & Co. KG
BIOTRONIK is a leading European manufacturer of medical technology with a worldwide market presence. The company offers a complete line of products for diagnosis, treatment and advanced therapy support in the areas of cardiac rhythm management, electrophysiology and vascular intervention.
The vascular intervention product range consists of guide wires, balloon catheters and stent systems for coronary and peripheral applications. BIOTRONIK invests heavily in research and development and is committed to pursuing future-oriented approaches to cardiovascular therapy.