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New Boston Scientific defibrillators receive CE Mark approval

Boston Scientific : 22 January, 2008  (New Product)
Boston Scientific has received CE Mark approval for the company’s Cognis cardiac resynchronisation therapy defibrillator (CRT-D) and Teligen implantable cardioverter defibrillator (ICD).
The devices are 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 32.5cc and 31.5cc respectively, while less than 10mm thick. Both devices offer features based on engineering advances, including extended battery longevity, self-correcting software and improved programming technology. Both devices also offer SafetyCore, 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: quickly proposes programmable device settings, which enables physicians to tailor individualised pacing therapy for their patients.

- Bi-V Trigger: helps physicians manage heart failure patients with frequent atrial arrhythmias.

- Electronic Repositioning: 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: designed to eliminate unnecessary ventricular pacing.

- Quick Convert: 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 revitalisation 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 US Food and Drug Administration and are not available for sale in the USA.
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