Boston Scientific Announces Clinical Data Supporting Safety and Efficacy of Platinum Chromium Promus Element(TM) Stent
By Boston Scientific Corporation, PRNETuesday, September 21, 2010
Nine-month Results From PLATINUM Clinical Program Presented at TCT
NATICK, Massachusetts, September 22, 2010 - Boston Scientific Corporation (NYSE: BSX) today announced data
from its PLATINUM QCA study, which is designed to evaluate the Company's
PROMUS Element(TM) Everolimus-Eluting Platinum Chromium Coronary Stent. The
results provided 30-day and nine-month clinical outcomes and nine-month
quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS)
data supporting the safety and efficacy of the PROMUS Element Stent. Analysis
of the data was presented by Ian Meredith, M.B.B.S., Ph.D., Director of
Cardiology at the Monash Medical Centre in Melbourne, Australia and Principal
Investigator of the PLATINUM QCA study, at the Cardiovascular Research
Foundation's annual Transcatheter Cardiovascular Therapeutics scientific
symposium in Washington, D.C.
The PROMUS Element Stent features a novel platinum chromium
(PtCr) alloy and innovative stent design, which combine to offer greater
radial strength and flexibility while reducing stent recoil. The stent
geometry helps create consistent lesion coverage and drug distribution while
improving deliverability, which is enhanced by an advanced catheter delivery
system. The higher density PtCr alloy provides superior visibility while
permitting thinner struts compared to prior-generation stents[1].
"The nine-month angiographic and IVUS data from the PLATINUM
QCA study are impressive and show the acute performance advantages of the
platinum chromium PROMUS Element Stent," said Prof. Meredith. "With the same
drug and polymer loading and comparable release kinetics as the PROMUS(R)
Stent, the PROMUS Element Stent achieved similar late loss and significantly
better stent apposition. These results give me great confidence in the
transferability of the everolimus drug and its proven clinical outcomes, as
well as the potential benefits of the new platinum chromium alloy."
The PLATINUM clinical program is evaluating the safety and
efficacy of the PROMUS Element Stent in five multi-center studies totaling
more than 1,800 patients, including a randomized controlled trial for
workhorse lesions, as well as single-arm studies evaluating small vessels,
long lesions and pharmacokinetics. The prospective, single-arm PLATINUM QCA
study enrolled 100 patients at 14 sites.
The PLATINUM QCA primary endpoint of 30-day composite cardiac
events was 1.0 percent, which included cardiac death (0.0 percent),
myocardial infarction (0.0 percent), target lesion revascularization (TLR,
1.0 percent) and stent thrombosis (ARC[2] definite/probable, 1.0 percent). Of
the 100 patients studied, one patient experienced a peri-procedural stent
thrombosis and TLR. No additional major clinical events were reported from 31
days to nine months.
The study also met its pre-specified efficacy endpoint of
in-stent late loss in workhorse lesions at nine months as measured by QCA
compared to historical TAXUS(R) Express(R) Stent data. The PROMUS Element
nine-month in-stent late loss of 0.17 mm plus or minus 0.25 mm was superior
to the performance goal of 0.44 mm (p<0.001) based on TAXUS Express
historical data and similar to in-stent late loss reported for the PROMUS
(Xience V(R)) Everolimus-Eluting Stent in the SPIRIT trials.
The study met a second pre-specified efficacy endpoint of
post-procedure incomplete stent apposition as measured by IVUS compared to
PROMUS (Xience V) data from the SPIRIT III trial. The PROMUS Element
post-procedure incomplete stent apposition of 5.7 percent was significantly
below the performance goal of 34.4 percent (p<0.001) based on PROMUS (Xience
V) historical data. The percent net volume obstruction at nine months as
measured by IVUS was also low at 7.2 percent.
"These results demonstrate the successful transfer of drug and
polymer from the PROMUS Stent to the PROMUS Element Stent," said Keith D.
Dawkins, M.D., Senior Vice President and Chief Medical Officer for Boston
Scientific's Cardiology, Rhythm and Vascular Group. "The PLATINUM QCA results
further support the performance of the everolimus drug/polymer combination
while demonstrating a highly effective platinum chromium PROMUS Element Stent
platform. The PROMUS Element Stent also demonstrates an excellent safety
profile in this study with only a single patient experiencing a cardiac event
within 30 days and no additional events through nine months."
"We are extremely pleased with the positive safety and
efficacy results of the PLATINUM QCA study, which reinforce the overall
benefits provided by our new platinum chromium stent platform," said Hank
Kucheman, Executive Vice President and President of Boston Scientific's
Cardiology, Rhythm and Vascular Group. "These favorable outcomes for our
everolimus-eluting PROMUS Element Stent, together with the recent European
launch of our paclitaxel-eluting TAXUS(R) Element(TM) Stent, illustrate our
unparalleled pipeline of drug-eluting stent technologies."
The Company expects U.S. Food and Drug Administration approval
for the TAXUS Element Stent System[3] 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.
The randomized, controlled PLATINUM Workhorse clinical trial
completed enrollment in September 2009 with 1,531 patients at more than 130
sites worldwide and compares the PROMUS Element Everolimus-Eluting Coronary
Stent System to the PROMUS (Xience V) Everolimus-Eluting Coronary Stent
System. One-year data from the trial will be presented at the Scientific
Session of the American College of Cardiology/i2 Summit in March 2011.
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.
The PROMUS Stent is a private-labeled Xience V
Everolimus-Eluting Coronary Stent System manufactured by Abbott and
distributed by Boston Scientific. The SPIRIT Clinical Program is sponsored by
Abbott.
About Boston Scientific
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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[1] Based on bench testing. Data on file with Boston Scientific.
[2] Academic Research Consortium
[3] The TAXUS Element Stent System will be commercialized as the ION(TM)
Paclitaxel-Eluting Platinum Chromium Coronary Stent System in the U.S.
CONTACT: Geraldine Varoqui International Public relations +49-170-782-85-58 varoquig@bsci.com
CONTACT: Geraldine Varoqui, International Public relations, +49-170-782-85-58, varoquig at bsci.com
Tags: Boston Scientific Corporation, Massachusetts, Natick, September 22