ARRIVE registry supports positive safety profile of TAXUS(R) Express(2)(TM) stent system in diabetic and other patients
25 Mai 2005 - 7:11PM
PR Newswire (US)
ARRIVE registry supports positive safety profile of TAXUS(R)
Express(2)(TM) stent system in diabetic and other patients
VANCOUVER, and PARIS, FRANCE, May 25 /PRNewswire-FirstCall/ --
Angiotech Pharmaceuticals, Inc. (NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP)
corporate partner, Boston Scientific ("BSC"), today announced
results from BSC's ARRIVE and Milestone II registries. The results
were announced during a symposia entitled "Post-Market Registries:
a Wealth of Real-Life Data," chaired by Mary Russell, M.D.,
F.A.C.C., Senior Vice President, Clinical and Regulatory, and Chief
Medical Officer at Boston Scientific. The symposium took place at
the annual Paris Course on Revascularization. "The TAXUS registries
confirm the outstanding performance of the TAXUS stent system in
diabetic subsets, patients requiring multiple stents and other
highly complex cases," said Dr. Russell. "When viewed in
combination with data from our TAXUS clinical trials, the results
paint a remarkably consistent picture of TAXUS as a safe and highly
efficacious treatment for patients with coronary artery disease."
ARRIVE ------ BSC states that the ARRIVE peri-approval registry has
enrolled nearly 2,600 consecutive patients at 50 sites in the
United States and features BSC's TAXUS(R) Express(2)(TM)
paclitaxel-eluting coronary stent system. (A peri-approval registry
includes patients who are enrolled before and after a product is
approved.) ARRIVE was initiated in cooperation with the U.S. Food
and Drug Administration (FDA) and is the first TAXUS registry in
the United States. The six-month clinical findings from ARRIVE
demonstrated safety based on a site-reported TAXUS related cardiac
adverse event rate of 4.3 percent (106/2,477), including
site-reported TAXUS related cardiac death, myocardial infarction
and reintervention of the target vessel, as reported by BSC. The
registry reported a stent thrombosis rate of 1.7 percent
(angiographically confirmed thrombotic events and all deaths less
than six months without obvious cause). ARRIVE reported a 95
percent follow-up at six months. Consecutive enrollment in ARRIVE
has yielded a very diverse patient population involving patients
receiving multi-vessel stenting (17 percent), left main stenting (3
percent), stenting of total occlusions (2 percent), stenting of
bifurcated lesions (8 percent), stenting of saphenous vein grafts
(6 percent) and stenting of in-stent restenonic lesions (7
percent). Ten percent of patients presented with an acute
myocardial infarction. For the diabetic population overall, the
TAXUS-related cardiac adverse event rate was 5.4 percent and the
need for repeat procedures was 3.1 percent. "ARRIVE has produced
exceptional 'real-world' results from patients who were
consecutively enrolled in the registry, which more closely
resembles the patients that we see in our day-to-day practice,"
said John Lasala, M.D., Ph.D., of Barnes-Jewish Hospital and
Washington School of Medicine in St. Louis and Co-Principal
Investigator of ARRIVE. "Given this highly complex patient
population, the results from ARRIVE are quite extraordinary. Of
particular note are the outstanding data derived from ARRIVE's
diabetic patient population, which represent 31 percent of those
enrolled in the registry." The ARRIVE registry enrolled patients at
low-, medium- and high-volume community-based health centers in the
United States. Enrollment has commenced in the ARRIVE 2 registry
program, which plans to enroll 5,000 patients at approximately 60
centers in the United States. The program is designed to collect
and analyze "real-world" safety and clinical outcomes data from the
TAXUS Express(2) paclitaxel-eluting stent system in the treatment
of patients with coronary artery disease. Milestone II ------------
The Milestone II registry was designed as a follow-up to the
Milestone I registry (which evaluated usage patterns of the
Express(2)(TM) bare-metal stent system) to assess the TAXUS
paclitaxel-eluting stent system. On a global basis, the registry
has enrolled 3,688 patients at 164 centers in 31 countries. BSC
today announced that the excellent global safety and efficacy data
reported at six months extends to 12 months, including physician
usage patterns. BSC acquired worldwide exclusive rights from
Angiotech to use paclitaxel to coat its coronary stent products and
has co-exclusive rights to other vascular and non-vascular
products. Vancouver-based Angiotech Pharmaceuticals, Inc. is a
specialty pharmaceutical company pioneering the combination of
pharmaceutical compounds with medical devices and biomaterials to
both create novel solutions for poorly addressed disease states and
dramatically improve surgical outcomes. To find out more about
Angiotech Pharmaceuticals, Inc. (NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP),
please visit our website at http://www.angiotech.com/. Statements
contained herein that are not based on historical or current fact,
including without limitation statements containing the words
"anticipates," "believes," "may," "continue," "estimate,"
"expects," "may" and "will" and words of similar import, constitute
"forward-looking statements" within the meaning of the U.S. Private
Securities Litigation Reform Act of 1995. Such forward-looking
statements involve known and unknown risks, uncertainties and other
factors that may cause the actual results, events or developments
to be materially different from any future results, events or
developments expressed or implied by such forward-looking
statements. Such factors include, among others, the following:
general economic and business conditions, both nationally and in
the regions in which the Company operates; technology changes;
competition; changes in business strategy or development plans; the
ability to attract and retain qualified personnel; existing
governmental regulations and changes in, or the failure to comply
with, governmental regulations; liability and other claims asserted
against the Company; and other factors referenced in the Company's
filings with the United States Securities and Exchange Commission
or the Canadian securities regulators. Given these uncertainties,
readers are cautioned not to place undue reliance on such
forward-looking statements. The Company does not assume the
obligation to update any forward-looking statements. CONTACTS: Todd
Young, Angiotech Pharmaceuticals (Analysts & Investors) (604)
221-7676 ext 6933 Rui Avelar, Angiotech Pharmaceuticals, Inc.
(Analysts) (604) 221-7676 ext 6996 Eric Starkman, Starkman &
Associates (Media) (212) 252-8545 ext 12 DATASOURCE: Angiotech
Pharmaceuticals, Inc. CONTACT: Todd Young, Angiotech
Pharmaceuticals, (Analysts & Investors), (604) 221-7676 ext
6933; Rui Avelar, Angiotech Pharmaceuticals, Inc., (Analysts),
(604) 221-7676 ext 6996; Eric Starkman, Starkman & Associates,
(Media), (212) 252-8545 ext 12
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