Boston Scientific Receives CE Mark for Stent System

Boston Scientific Corp. has received a CE Mark for its PROMUS Element Everolimus-Eluting Coronary Stent System, according to the firm.

The PROMUS Element system incorporates a platinum chromium alloy with an advanced catheter delivery system, the firm said.

The company will begin marketing the PROMUS Element system immediately in the European Union and other CE Mark countries.

The platinum chromium alloy used in the PROMUS Element stent is engineered specifically for coronary stenting, according to the Natick, Mass.-basec company.

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.

“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,” said David McFaul, Boston Scientific senior vice president, International.

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.