Boston Scientific Begins PLATINUM PLUS Trial for PROMUS(R) Element(TM) Stent System
By Boston Scientific Corporation, PRNETuesday, May 25, 2010
Randomized Study of Nearly 3,000 Patients to Evaluate Company's Third-Generation Drug-Eluting Stent Technology
NATICK, Massachussetts, May 26, 2010 - Boston Scientific Corporation (NYSE: BSX) today announced the
initiation of the PLATINUM PLUS clinical trial, an investigator-sponsored
research (ISR) study designed to compare the performance of the PROMUS(R)
Element(TM) Everolimus-Eluting Coronary Stent System to the XIENCE PRIME(TM)
Everolimus-Eluting Coronary Stent System. The PROMUS Element Stent, which
received CE Mark in October 2009, is Boston Scientific's third-generation
drug-eluting stent technology and incorporates a platinum chromium alloy with
an innovative stent design and an advanced catheter delivery system.
PLATINUM PLUS is a prospective, randomized, multi-center
clinical trial with planned enrollment of 2,980 patients at 50 sites in
France, Germany, Italy, Spain and the U.K. It will evaluate coronary
revascularization outcomes in an unrestricted patient population randomized
(2:1) to receive a PROMUS Element Stent or XIENCE PRIME Stent. The primary
endpoint is 12-month target vessel failure with planned follow-up out to 34
months. The trial is funded by a research grant from Boston Scientific and
led by Principal Investigator Jean Fajadet, M.D., Clinic Pasteur, Toulouse,
France and Co-Principal Investigator Eulogio Garcia, M.D., Clinico San
Carlos, Madrid, Spain. Results are expected to be presented in 2012.
"We are very enthusiastic about beginning the first
large-scale randomized trial that compares the new platinum chromium PROMUS
Element Stent with the XIENCE PRIME Stent," said Dr. Fajadet. "The results
should demonstrate how two distinct stent platforms, with the same everolimus
drug, perform in a head-to-head comparison."
The PROMUS Element Stent is designed specifically for coronary
stenting. 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 PLATINUM PLUS trial is coordinated by the Centre Europeen
de Recherche Cardiovasculaire (CERC) under the direction of Marie-Claude
Morice, M.D. CERC is an interventional cardiology clinical research
organization based in Paris.
"This is an important study that could provide insights on the
potential benefits of third-generation drug-eluting stents in an all-comers
trial reflecting the daily clinical practice of interventional
cardiologists," said Dr. Morice.
The PLATINUM PLUS trial will provide data that may complement
Boston Scientific's PLATINUM clinical trial, which completed enrollment of
1,531 patients at 133 sites worldwide in September 2009. PLATINUM is a
randomized, controlled, pivotal trial designed to support U.S. Food and Drug
Administration (FDA) and Japanese Ministry of Health, Labor and Welfare
(MHLW) approval of the PROMUS Element Stent System.
In addition to offering the PROMUS Element Everolimus-Eluting
Coronary Stent System in the European Union and other CE Mark countries, the
Company plans to launch the TAXUS(R) Element(TM) Paclitaxel-Eluting Coronary
Stent System in these markets next month. Both Element Systems incorporate
the same platinum chromium alloy, innovative stent design and advanced
catheter delivery system. The Company expects FDA approval for the TAXUS
Element Stent System in mid 2011 and for the PROMUS Element Stent System in
mid 2012. It expects MHLW approval for the TAXUS Element Stent System in late
2011 or early 2012 and for the PROMUS Element Stent System in mid 2012.
In the U.S., the PROMUS Element and TAXUS Element Stent
Systems are investigational devices and are limited by applicable law to
investigational use only and are not available for sale.
XIENCE PRIME is a trademark of the Abbott Laboratories group
of companies.
Boston Scientific is a worldwide developer, manufacturer and
marketer of medical devices whose products are used in a broad range of
interventional medical specialties. For more information, please visit:
www.bostonscientific.com.
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CONTACT: Paul Donovan +1-508-650-8541 (office) +1-508-667-5165 (mobile) Media Relations Boston Scientific Corporation Larry Neumann +1-508-650-8696 (office) Investor Relations Boston Scientific Corporation --------------------------------- [1] Based on bench testing. Data on file with Boston Scientific.
CONTACT: Paul Donovan, +1-508-650-8541 (office), +1-508-667-5165 (mobile), Media Relations, Boston Scientific Corporation ; Larry Neumann, +1-508-650-8696 (office), Investor Relations, Boston Scientific Corporation
Tags: Boston Scientific Corporation, Massachusetts, Massachussetts, May 26, Natick