Boston Scientific launches Promus Element Stent System in Europe
3 November 2009
Boston Scientific Corporation (NYSE:BSX) has announced it has
gained EU approval for its Promus Element Everolimus-eluting
coronary stent system, the company's third-generation drug-eluting stent
The Promus Element system incorporates a unique platinum chromium alloy
with an innovative stent design and an advanced catheter delivery
The Company will begin marketing the Promus Element system
immediately in the European Union 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
"The platinum chromium alloy and new stent design used in the Promus
Element stent represent significant innovations in drug-eluting stent
technology," said Bruno Farah, M.D., Clinique Pasteur, Toulouse, France.
"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."
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
"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.
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
In the U.S., the Promus Element and TAXUS Element systems are
investigational devices and are limited by applicable law to
investigational use only and are not available for sale.