Boston Scientific Corporation (Boston Scientific) said it has received CE Mark for its PROMUS Element Everolimus-Eluting Coronary Stent System, the company's third-generation drug-eluting stent (DES) technology. The company claims that the PROMUS Element system incorporates a unique platinum chromium alloy with an innovative stent design and an advanced catheter delivery system.
The company will begin marketing the PROMUS Element system immediately in the EU and other CE Mark countries. CE Mark was granted by the Dutch Notified Body KEMA Quality B.V.
The platinum chromium alloy used in the PROMUS Element stent is engineered specifically for coronary stenting. This proprietary alloy offers greater radial strength and flexibility than older alloys such as the cobalt chromium alloy used in the XIENCE PRIME DES, and it provides enhanced visibility and reduced recoil. The innovative stent design improves deliverability and allows for more consistent lesion coverage and drug distribution. The advanced catheter delivery system further improves deliverability.
In addition to the PROMUS Element Everolimus-Eluting Coronary Stent System, the company plans to offer the TAXUS Element Paclitaxel-Eluting Coronary Stent System. Both Element systems incorporate the platinum chromium alloy with the innovative stent design and advanced catheter delivery system.
“We are proud to introduce our third-generation drug-eluting stent to physicians and patients in Europe and other CE Mark countries,” said David McFaul, Boston Scientific Senior Vice President, International. “The PROMUS Element system is the latest example of Boston Scientific’s commitment to DES market leadership and continued innovation. 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. We are confident our Element series will further extend our global DES leadership.”
The PROMUS Element system is being evaluated in the PLATINUM clinical trial, which completed enrollment of 1,532 patients in September at more than 140 sites worldwide. PLATINUM is a randomized, controlled, pivotal trial designed to support US Food and Drug Administration (FDA) and Japanese Ministry of Health, Labor and Welfare (MHLW) approval of the PROMUS Element system. The TAXUS 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.
Boston Scientific 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.