Bülach, Switzerland - 16 February 2009. BIOTRONIK AG, a leading manufacturer of Vascular Interventional devices, 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.
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.
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.
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