Boston Scientific receives EU approval for platinum chromium stent
14 May 2010
Boston Scientific Corporation (NYSE:BSX) has received CE Mark
approval for its Taxus Element Paclitaxel-Eluting Coronary Stent System,
the Company's third-generation drug-eluting stent (DES) technology.
This approval includes a specific indication for the treatment of
diabetic patients. The system incorporates a platinum chromium alloy
with an innovative stent design and an advanced catheter delivery
system. The Company plans to launch it next month in the European
Union and other CE Mark countries.
"In my experience, the platinum chromium alloy and new stent
design used in the Taxus Element Stent offer increased flexibility,
visibility and deliverability," said Dean Kereiakes, M.D., Medical
Director at The Christ Hospital Heart and Vascular Center and The
Lindner Research Center in Cincinnati and the Principal Investigator
for the PERSEUS clinical program.
"The Element platform represents a significant advance in
coronary stenting with performance improvements that could simplify
procedures and allow treatment of a broader range of patients. The
combination of the proven Taxus drug and polymer with the new
Element platform provides a welcome treatment option."
"As the worldwide prevalence of diabetes continues to increase
dramatically, the diabetic indication for the TAXUS Element Stent
System represents an important benefit for diabetic patients being
treated for coronary artery disease," said Hank Kucheman, Executive
Vice President and Group President, Cardiology, Rhythm and Vascular
for Boston Scientific. "The Taxus Element Stent System, with the
proven performance of paclitaxel, provides an advanced treatment
option for diabetic patients. This product's unique mechanism of
action helps to inhibit restenosis in high-risk patients with
diabetes, and we are pleased to offer it to these patients."
The Taxus Element Stent is designed specifically for coronary
stenting and leverages the performance advantages of the Element
platform with a decade of clinical success from the Taxus program.
The novel stent architecture and proprietary platinum chromium alloy
combine to offer greater radial strength and flexibility. The stent
architecture helps create consistent lesion coverage and drug
distribution while improving deliverability, which is enhanced by an
advanced catheter delivery system. The higher density alloy provides
superior visibility and reduced recoil while permitting thinner
struts compared to prior-generation stents (1).
The Company received CE Mark approval for the Promus Element
Everolimus-Eluting Stent System in October 2009. Both Element
systems incorporate the same platinum chromium alloy, innovative
stent design and advanced catheter delivery system.
In the US, the Company expects FDA approval for the Taxus Element
Stent System in mid 2011 and for the PROMUS Element Stent System in
mid 2012. In Japan, the Company expects approval for the Taxus
Element Stent System in late 2011 or early 2012 and for the Promus
Element Stent System in mid 2012.