Boston Scientific has received CE mark for its Promus Element Everolimus-Eluting Coronary Stent System (PEEECSS), the company’s third-generation drug-eluting stent (DES) technology.
Boston Scientific will begin marketing the Promus system immediately in the European Union and other CE Mark countries. CE Mark was granted by the Dutch notified body KEMA Quality BV.
Promus system incorporates platinum chromium alloy with stent design and a catheter delivery system. The proprietary alloy offers radial strength and flexibility than older alloys and it provides visibility and reduced recoil. The stent design improves deliverability and allows for more consistent lesion coverage and drug distribution. The advanced catheter delivery system further improves deliverability.
The company also plans to offer the Taxus element paclitaxel-eluting coronary stent system. Both systems incorporate the platinum chromium alloy with the stent design and latest catheter delivery system.
Bruno Farah, clinique pasteur of Toulouse, France, said: “The platinum chromium alloy and new stent design used in the Promus element stent represent significant innovations in drug-eluting stent technology. In my experience, the element platform offers a stenting option that provides superior deliverability and visibility with excellent comformability and low recoil. I believe it offers performance improvements that could simplify procedures and allow treatment of a broader range of patients.”
David McFaul, Boston Scientific senior vice president, International, said:”We are proud to introduce our third-generation drug-eluting stent to physicians and patients in Europe and other CE mark countries. We also plan to launch the Taxus element system in CE mark countries next year, giving physicians the choice of two proven drug and polymer combinations – used in millions of patients worldwide – on an entirely new stent platform.”
The promus element system is being evaluated in the Platinum clinical trial and theTaxus element system is being evaluated in the Perseus trial, which completed enrollment in October 2008 and will report primary endpoint data at the American college of cardiology conference in March, 2010.
The company anticipates FDA approval for the promus element system in 2012. The Taxus element system was launched in select international markets in May. CE mark approval for the Taxus element system is expected in the second quarter of 2010, and FDA approval is expected in 2011.