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Vascular Intervention - Final Multi BENE results confirm outstanding safety and efficacy of the PROBIO® coated PRO-Kinetic Coronary Stent

Compelling and consistent clinical and angiographic results at 6 and 12 months demonstrated by the Multi BENE study using the PRO-Kinetic Stent System with PROBIO® coating

(PresseBox) (Barcelona, Spain, ) Dr. Maarten J. Suttorp, MD, PhD, Director of Department of Interventional Cardiology at the Antonius Hospital in Nieuwegein, Netherlands; and Co-PI of the Multi BENE trial, presented impressive results with the BIOTRONIK Cobalt Chromium stent system at the annual EuroPCR Meeting in Barcelona, Spain. "No stent thrombosis and no cardiac death after 12 months are reassuring for both patients and cardiologists", said Dr. Suttorp after the abstract session at EuroPCR.

The Multi BENE trial, a prospective, multi-center, single-arm study, enrolled 202 patients to demonstrate efficacy and safety of BIOTRONIK's PRO-Kinetic Coronary Stent System.

Total MACE (comprised death, MI, TLR and CABG) at six and twelve months was 11.9% and 13.9% respectively. Considering an alternative definition of MACE which includes cardiac death, MI, ischemia-driven TLR and TVR-CABG would amount to 9.9% at six and 11.4%, at twelve months.

"With a low MACE rate, including ischemic events, of less than 10% at six months and not a single case of stent thrombosis after one year, BIOTRONIK reconfirms the excellent outcomes with the PRO-Kinetic stent which have been experienced by implanting physicians around the world," said VP of Sales and Marketing Vascular Intervention, Alain Aimonetti. "This study reflects the previous results we've seen in the 'PRO-Kinetic Real World Registry' which had similar MACE rates. Our best-in-class stent platform consistently demonstrates superior performance over a variety of patient characteristics."

In the Multi BENE (MULTIcentric BElgium/NEtherlands PRO-Kinetic Safety and Efficacy) study, twelve coronary intervention centers in Belgium, the Netherlands and Germany participated and enrolled 202 patients in total. 82 patients were angiographically followed-up after six months. All patients were clinically reviewed at 12 months.

Secondary endpoints included in-stent Late Lumen Loss (LLL) at 6 months, reported at 0.59 mm. This angiographic result demonstrated the high efficacy of the stent device.
Procedural, lesion and device success were greater than 94%*.

"The PRO-Kinetic is an optimal solution for patients who do not necessarily require or who cannot have a drug-eluting stent," said VP of Technology Vascular Intervention , Dr.
Felix Baader. "Thin struts, a double helical design and the PROBIO® passive coating make our device one of the best performing in the bare-metal stent market. The late lumen loss result of 0.59 mm can rival some drug-eluting stents."

The PRO-Kinetic Cobalt Chromium Stent System is a flagship product from BIOTROINK that demonstrates the advanced engineering that goes into the products they develop and manufacture. This stent's cobalt chromium material allows for very thin struts and in combination with an elaborate double-helical design yield exceptional flexibility and ease of delivery even in highly complex and torturous anatomies. For surface passivation, the stent is sealed with PROBIO® coating: a silicone carbide layer that improves the haemoand biocompatibility, allowing the PRO-Kinetic coronary stent to achieve excellent clinical results. PRO-Kinetic is indicated for the treatment of coronary arteries of 2.0 to 5.0 mm in diameter.

* Defined as attainment of <30 residual stenosis by QCA measurement.

BIOTRONIK

As one of the world's leading cardiovascular medical device companies, with several million implanted devices, BIOTRONIK is represented in over 100 countries with its global workforce of more than 4000 employees. Known for having its finger on the pulse of the medical community, BIOTRONIK assesses the challenges physicians face, and provides the best solutions for all phases of patient care, ranging from diagnosis to treatment to patient management. Quality, innovation and reliability define BIOTRONIK and its growing success, and deliver confidence and peace of mind to physicians and their patients worldwide.