Navigation Links
Boston Scientific Completes Clinical Trial Enrollment for Third-Generation Drug-Eluting Stent
Date:10/8/2008

PERSEUS clinical program to evaluate TAXUS(R) Element(TM) Platinum Chromium

Stent

NATICK, Mass., Oct. 8 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced that it has completed enrollment in the PERSEUS trial, designed to evaluate the Company's third-generation TAXUS(R) Element(TM) paclitaxel-eluting coronary stent. The PERSEUS clinical program has enrolled nearly 1,500 patients at 100 U.S. and international centers since July 2007, and will compare the TAXUS Element Stent to the prior-generation TAXUS(R) Express2(TM) Stent marketed in the United States since 2004. The Company plans to develop additional versions of the Element platform, including next generations of a bare-metal stent and an everolimus-eluting PROMUS(R) Element stent system.

"We are pleased to reach this important milestone in the development of our third-generation drug-eluting stent, at a time when most companies are still introducing their first-generation stents in the U.S.," said Keith Dawkins, M.D., Senior Vice President and Associate Chief Medical Officer for Boston Scientific. "Boston Scientific is the only company to offer interventionalists a choice between two different drugs in a DES platform. The advanced Platinum Chromium Alloy and new balloon catheter offered in the Element system will further strengthen our deep portfolio of coronary stent technologies."

The Element Stent platform features the proprietary Platinum Chromium Alloy, designed specifically for stents. This alloy, coupled with an innovative new stent architecture, is designed to enable thinner struts for increased flexibility, a lower profile, and improved radial strength, recoil, and radiopacity. In addition, the TAXUS Element Stent System incorporates new balloon technology, intended to improve on Boston Scientific's market-leading Maverick(R) Balloon Catheter platform.

"The new alloy and stent design of TAXUS Element provides improved deliverability and visibility, even in patients with complex and challenging anatomy," said Dean J. 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 trials. "I am very enthusiastic about the potential the TAXUS Element Stent offers me to treat a broader range of patients."

The TAXUS PERSEUS clinical program will evaluate the efficacy and safety of the TAXUS Element Stent in two studies.

The first study, TAXUS PERSEUS Workhorse (A Prospective Evaluation in a Randomized Trial of the Safety and Efficacy of the Use of the TAXUS Element Paclitaxel-Eluting Coronary Stent System for the Treatment of De Novo Coronary Artery Lesions), will evaluate the safety and efficacy of the TAXUS Element Stent compared to Boston Scientific's first generation drug-eluting stent, the TAXUS(R) Express(TM) Stent. This 3:1 randomized study will evaluate 1,264 patients from 94 sites in the U.S., Australia, New Zealand and Singapore with "workhorse" lesions from 2.75 to 4.0 millimeters in diameter. The primary endpoint of the workhorse study is target lesion failure (TLF) at 12 months, and its secondary endpoint is in-segment percent diameter stenosis at nine months.

A second parallel study named the TAXUS PERSEUS Small Vessel study will compare the TAXUS Element Stent to a historic control (TAXUS V de novo bare-metal Express(R) Coronary Stent System). This study will include 224 patients from 35 U.S. sites with lesions from 2.25 up to 2.75 millimeters. The primary endpoint of the small vessel study is in-stent late loss at nine months, and its secondary endpoint is TLF at 12 months.

The TAXUS Element Stent is an investigational device and is limited by Federal law to investigational use only and is not available for sale. Boston Scientific is currently seeking CE Mark approval in European markets, which is anticipated in 2009.

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: http://www.bostonscientific.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. These forward- looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding clinical trials, regulatory approvals, competitive offerings, product performance and our market position. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward- looking statements.

Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and, future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A - Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A - Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file thereafter. We disclaim any intention or obligation to publicly update or revise any forward- looking statements to reflect any change in our expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. This cautionary statement is applicable to all forward-looking statements contained in this document.

CONTACT:

Paul Donovan

508-650-8541 (office)

508-667-5165 (mobile)

Media Relations

Boston Scientific Corporation

Larry Neumann

508-650-8696 (office)

Investor Relations

Boston Scientific Corporation


'/>"/>
SOURCE Boston Scientific Corporation
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Wound Management Technologies, Inc. Announces Conference Plans in Boston and Additional Clinical Research on CellerateRx(R)
2. NIH Funds New Wellstone Research Center for Muscular Dystrophy at Boston Biomedical Research Institute
3. Boston Scientific Announces Schedule for European Society of Cardiology Congress 2008
4. Boston University and The Center for Human Genetics, Inc. Announce Change in Testing Services
5. Headache Specialists Convene in Boston For 50th Annual American Headache Society Meeting
6. Leading Immunologists Convene in Boston
7. Seven Presentations by Two Independent Research Groups Highlight Advantages of Pressure Cycling Technology (PCT) at Scientific Symposia in Philadelphia, Boston, and New York City
8. Multi-Center Patient Registry Supports Safety and Clinical Utility of Boston Scientifics SpyGlass(R) Direct Visualization System
9. SPIRIT III Results Reaffirm Strong Performance of Boston Scientific PROMUS(TM) and TAXUS(R) Express(R) Stents
10. Cequent Pharmaceuticals Johannes Fruehauf, MD, Ph.D., to be Featured Speaker at RNAi World Congress in Boston - May 2, 2008
11. Spirit II Results Support Strength of Boston Scientifics Two Drug-Eluting Stent Platforms
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... , June 24, 2016  Collagen Matrix, ... design, development and manufacturing of collagen and mineral ... announced today that Bill Messer has ... Marketing to further leverage the growing portfolio of ... devices. Bill joins the Collagen Matrix ...
(Date:6/24/2016)... -- The Academy of Managed Care Pharmacy (AMCP) today ... allow biopharmaceutical companies to more easily share health care ... coverage decisions, a move that addresses the growing need ... The recommendations address restrictions in the sharing of product ... a prohibition that hinders decision makers from accessing HCEI ...
(Date:6/24/2016)... Mass. , June 24, 2016   Pulmatrix, ... pharmaceutical company developing innovative inhaled drugs, announced today that ... Russell Investments reconstituted its comprehensive set of ... "This is an important milestone for Pulmatrix," ... will increase shareholder awareness of our progress in developing ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... Austin residents seeking Mohs surgery services, can now ... and to Dr. Russell Peckham for medical and surgical dermatology. , Dr. Dorsey brings ... The selective fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey was under the ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... As a ... Magna Cum Laude and his M.D from the David Geffen School of Medicine at ... returned to Los Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars ...
(Date:6/24/2016)... , ... June 24, 2016 , ... A recent ... most people are unfamiliar with. The article goes on to state that individuals are ... many of these less common operations such as calf and cheek reduction. The Los ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Pulmonary Hypertension Association (PHA) ... will receive two significant new grants to support its work to advance research ... anniversary by recognizing patients, medical professionals and scientists for their work in fighting ...
(Date:6/24/2016)... ... , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway Pain Relief Products, join The ‘Business ... to $12 an hour by 2020 and then adjusting it yearly to increase at the ... minimum wage, assure the wage floor does not erode again, and make future increases more ...
Breaking Medicine News(10 mins):