Corporation (NYSE: BSX) 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
— 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
— Reverse Mode Switch(TM): designed to eliminate unnecessary ventricular
— 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
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:
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Boston Scientific Corporation