Platinum-based coronary stent awarded CE Mark 3rd November 2009
A new platinum-based stent has received its CE Mark and will now be available in the relevant countries, it was confirmed yesterday (2nd November).
The PROMUS Element Everolimus-Eluting Coronary Stent System, designed by Boston Scientific, was granted approval by the Dutch notified body KEMA Quality BV.
In addition to featuring a platinum chromium alloy designed specifically for coronary stenting, the system has an innovative stent structure and an impressive catheter delivery mechanism.
"We are proud to introduce our third-generation drug-eluting stent to physicians and patients in Europe and other CE Mark countries," said Boston Scientific International Senior Vice-President David McFaul.
Mr McFaul also confirmed that the company is planning to launch its TAXUS Element system - which also includes the platinum chromium alloy - in CE Mark countries next year.
He noted that it will give "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 currently being trialled by 1,532 patients at 140 sites across the globe and is expected to receive US Food and Drug Administration approval in 2012.
Boston Scientific's medical devices are used in a host of processes, such as interventional cardiology, neuromodulation, electrophysiology, cardiac surgery, vascular surgery, endoscopy, oncology, urology and gynaecology.
Source:
BOSTON SCIENTIFIC ANNOUNCES EUROPEAN APPROVAL AND LAUNCH OF PLATINUM CHROMIUM PROMUS® ELEMENT™ STENT SYSTEM (02/11/09)
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