Navigation Links
Boston Scientific Announces CE Mark Approval for New Devices to Treat Heart Failure and Sudden Cardiac Death
Date:1/22/2008

NATICK, Mass., Jan. 22 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced CE Mark approval for its COGNIS(TM) cardiac resynchronization therapy defibrillator (CRT-D) and TELIGEN(TM) implantable cardioverter defibrillator (ICD). These devices represent entirely new platforms to treat heart failure and sudden cardiac death and are the result of a multi-year research and development effort to provide physicians enhanced clinical options for their patients.

When choosing a high-energy device, physicians often must make trade-offs among device size, battery longevity and features. The COGNIS CRT-D and the TELIGEN ICD are designed to eliminate those compromises.

They are among the world's smallest and thinnest high-energy devices at 32.5 cc and 31.5 cc respectively, while less than 10 mm thick. Both devices offer features based on significant engineering advances, including extended battery longevity, self-correcting software and improved programming technology. Both devices also offer SafetyCore(TM), a feature that in the unlikely event of a system error provides lifesaving shock therapy and basic pacing functionality.

Key features of the COGNIS CRT-D include:

-- SmartDelay(TM): quickly proposes programmable device settings, which

enables physicians to tailor individualized pacing therapy for their

patients

-- Bi-V Trigger: helps physicians manage heart failure patients with

frequent atrial arrhythmias

-- Electronic Repositioning(TM): provides physicians with six

configurations for stimulating the left side of the heart even after

implant, which may help avoid an additional surgical procedure

Key features of the TELIGEN ICD include:

-- Thinnest device available in the world, designed with patient comfort

in mind

-- Reverse Mode Switch(TM): designed to eliminate unnecessary ventricular

pacing

-- Quick Convert(TM): provides the ability for patients to receive pacing

therapy for ventricular tachycardias

"Our CRM team is refocused on delivering therapy systems that meet clinician needs for safety, reliability and better patient outcomes," said Jim Tobin, President and Chief Executive Officer of Boston Scientific. "We have re-engineered the way we design, build, test and report on our technology. The COGNIS CRT-D and the TELIGEN ICD are testaments to the revitalization of our CRM business and are just two of the many new products we plan to launch in 2008."

The first COGNIS and TELIGEN implants are scheduled to take place early next month. The Company plans to build to a full launch in Europe and other international markets in the second quarter.

The COGNIS CRT-D and the TELIGEN ICD are pending approval by the U.S. Food and Drug Administration and are not available for sale in the United States.

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 our product performance, regulatory approval of our products, new product launches, competitive offerings, our growth strategy, 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

Dan Brennan

508-650-8538 (office)

617-459-2703 (mobile)

Investor Relations

Boston Scientific Corporation


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

Related medicine technology :

1. Vicus Therapeutics to Present at the 234th American Chemical Society National Meeting in Boston, MA
2. Boston Scientific Announces Schedule for European Society of Cardiology Congress 2007
3. Boston University Biomedical Engineers Find Chink in Bacterias Armor
4. Boston Scientific to Release Broad Range of Clinical Trial Data Reinforcing Safety and Efficacy of Taxus(R) Coronary Stent Systems at TCT 2007
5. Preliminary Results of Randomized Pilot Study Show Comparable Efficacy for OrbusNeichs Genous(TM) Bio-engineered R Stent(TM) and Boston Scientifics Taxus(R) Stent in Patients at High Risk of Restenosis
6. Boston Scientific PROMUS(TM) and TAXUS(R) Stents Continue Strong Performance in Safety and Efficacy Measures
7. Boston Scientifics Next-Generation Stent Shows Improved Clinical Outcomes in Complex Lesions
8. Positive Five-Year Safety Data for TAXUS(R) Stent Reported in Boston Scientific Trial
9. Boston Scientific Carotid Artery Stenting Trials Produce Positive Three-Year Results
10. Award-Winning Medicine Wheel Returns to the Cyclorama at the Boston Center for the Arts on Dec. 1 for 24-hour Vigil Recognizing World AIDS Day
11. Thomson Scientific Publishes The Ones to Watch - A Quarterly Review of Phase Changes in the Pharmaceutical Pipeline
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... LOS ANGELES , June 23, 2016 /PRNewswire/ ... (NASDAQ: CAPR ), a biotechnology company ... first-in-class therapeutics, today announced that patient enrollment in ... progrEssion in Duchenne) has exceeded 50% of its ... its enrollment in the third quarter of 2016, ...
(Date:6/23/2016)... 23, 2016 , , , ... 7, 2016 , , , , LOCATION: , , , ... , , , EXPERT PANELISTS:  , , , Frost & Sullivan,s ... Christi Bird; Senior Industry Analyst, Divyaa Ravishankar and Unmesh Lal, Program ... global pharmaceutical industry is witnessing an exceptional era. Several new demand ...
(Date:6/23/2016)... , June 23, 2016 Revolutionary ... Oticon , industry leaders in advanced audiology ... of Oticon Opn ™, the world,s first internet ... possibilities for IoT devices.      (Photo: ... introduces a number of ,world firsts,: , ...
Breaking Medicine Technology:
(Date:6/24/2016)... ... 2016 , ... Those who have experienced traumatic events may suffer from a ... such as drug or alcohol abuse, as a coping mechanism. To avoid this pain ... following a traumatic event. , Trauma sufferers tend to feel a range of emotions, ...
(Date:6/24/2016)... Dallas, Texas (PRWEB) , ... June 24, 2016 ... ... 12th International Conference and Scientific Sessions in Dallas that it will receive two ... Announcement of the grants came as PHA marked its 25th anniversary by recognizing ...
(Date:6/24/2016)... Diego, CA (PRWEB) , ... June 24, 2016 , ... ... with the American Cancer Society and the Road To Recovery® program to drive cancer ... to seniors and other adults to ensure the highest quality of life and ongoing ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... Clinical Decision Making in Emergency Medicine conference in Ponte Vedra Beach, FL. The ... published in Emergency Medicine Practice and Pediatric Emergency Medicine Practice. , ...
(Date:6/24/2016)... ... 24, 2016 , ... Strategic Capital Partners, LLC (SCP) in ... investment capital for emerging technology companies. SCP has delivered investment events and ... more than a million dollars of capital investment for five companies. ...
Breaking Medicine News(10 mins):