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BIOTRONIK Launches A New Generation Cobalt Chromium Stent System With PROBIO Coating

BIOTRONIK AG announced the launch of their new generation PRO-Kinetic (PK) Energy Stent System with PROBIO silicon carbide coating. The company begins launching this product immediately in all countries accepting CE Mark approval. The new PK Energy Stent System makes use of the company’s Pantera balloon technology to improve the deliverability of the stent. The Pantera PTCA Balloon Catheter was launched in mid 2008 and has received extremely positive reviews as an exceptional balloon for crossing difficult to treat lesions. “We see that today’s patients that are treated with PCI are becoming more and more complex with more severe disease and complex lesions. We felt that improving the already excellent deliverability of the PRO-Kinetic can add value to treating these patients,” said Alain Aimonetti, Vice President of Sales & Marketing. ”The Pantera balloon makes use of more flexible and thinner materials and our first experiences make us confident that the PK Energy will be a welcome tool in the modern cath lab.” Additional improvements of the PK Energy include minor adjustments to stent design to optimize the overall tension distribution and a new thermal crimping technology. The PK Energy Stent was designed with a double helical shape that gives it high flexibility and a smooth crimp profile, while the cobalt chromium material allows for some of the thinnest struts on the market today (60µm / 0.0024 inches). The new delivery system with new balloon material ensures greater flexibility for added deliverability for the most tortuous anatomies and difficult lesions. As with all stents from BIOTRONIK, the new PK Energy continues to have the PROBIO silicon carbide coating. This ultra thin, passive layer prevents allergenic ions from being released from the stent surface. By eliminating this process, stents coated with PROBIO, have a dramatic reduction in thrombus formation and greater haemocompatibility. "Through accelerating rapid endothelialisation to an earlier functional layer, PROBIO coating on ultra-thin cobalt chromium stents leads to less recurrent restenosis after stent placement without increased occurrence of stent thrombosis. In our latest publication, we have found a very low TLR rate of 4.9% and a 0.75 mm late loss that is close to some drug-eluting stents seen on the market," said Prof. Johannes B. Dahm from the Heart -& Vascular Center Neu-Bethlehem in Göttingen, Germany, on his recent publication in EuroIntervention on the PRO Heal Registry. This positive effect is also reflected in the interim results from the company’s Multi BENE study, a prospective, multi-center trial looking at the safety and efficacy of the PRO-Kinetic, that have shown very low MACE (8.1%) and TLR (8.1%) rates at 6 months. The full 6-month results of the Multi BENE study are scheduled to be presented in Q2/2009.