A year after the FDA lifted restrictions on a unit of Boston Scientific (Natick, Massachusetts) that had prohibited the company from winning product approvals for cardiac rhythm management devices, the company reported rapid approval of its Cognis cardiac resynchronization therapy defibrillator and Teligen implantable cardioverter defibrillator.

Both are the result of newly developed platforms to treat heart failure and sudden cardiac death.

"Boston Scientific completed the purchase of Guidant two years ago," Chas Mckhann, vice president of marketing for Boston Scientific CRM, told Medical Device Daily. "Since then, we've invested hundreds of millions of dollars into quality improvements. We've re-engineered the company; completely overhauled the organization. Our goal has been dramatic improvements. We're now seeing the benefits of that effort with the fast approvals from FDA."

In 2006, a day after Boston Scientific won its bid to acquire Guidant (Indianapolis) for about $27.2 billion, the FDA warned it of companywide quality failures that could possibly hold up future product approvals (MDD, Jan. 30, 2006). It was only the third such corporate-wide FDA warning letter ever issued to a device company.

Specifically, the agency cited Boston Scientific's management for not properly tracking complaints over certain products, including its Taxus stent, as well as Vaxcel catheters, Leveen needle electrodes and the Enteryx device used in surgery to treat acid reflux.

A year ago last month, FDA lifted restrictions from a warning letter following the agency's re-inspection of one of its plants in St. Paul, Minnesota, that makes cardiac rhythm management devices (MDD, April 17, 2007).

"In this year alone, we've had 10 major regulatory approvals," Mckhann said. "We filed for the Cognis and Teligen approvals late last year and got approval mid-May. Given the extent of the changes in these devices, they came in record time. We are very gratified."

Cognis and Teligen were built from a common platform known as Frontier, which has been Boston Scientific's single largest project investment. "It's a huge platform," Mckhann said. "The term 'new platform' is used in many different contexts, but in this case we have new hardware, software, a new battery and a new user interface. We redesigned the entire platform."

A major advantage of both devices is their size, which is much smaller than similar devices on the market, according to Boston Sci. The company did so with older and female patients in mind.

The Cognis CRT-D and the Teligen ICD are 32.5 cc and 31.5 cc, respectively, and both are less than 10 mm thick. Both also have extended battery longevity over previous company devices, self-correcting software and improved programming technology.

"From a patient comfort standpoint, the new sizes work very well," he said. "In Europe, where both were already launched, we've had a good patient response."

The new battery technology provides a life of six years for Cognis and seven to eight years for Teligen, both about one year longer than previously available.

Boston Scientific also has enhanced safety mechanisms with SafetyCore, which provides lifesaving shock therapy and basic pacing functionality in the event of a system error.

"SafetyCore is essentially a redundant hardware feature," Mckhann said. "If anything happens to the main hardware, there is back-up circuit to provide a shock if necessary."

Key features of the Cognis include:

• SmartDelay programmable device settings, which enable physicians to tailor individualized pacing therapy for their patients.

• Bi-V Trigger, which helps physicians manage heart failure patients with frequent atrial arrhythmias.

• Electronic repositioning, which provides physicians with six configurations for stimulating the left side of the heart even after implant, which may help avoid an additional surgical procedure.

Teligen capabilities include:

• Quick Convert, which provides the ability for patients to receive pacing therapy for ventricular tachycardias.

• Enhanced AV Search algorithm, designed to minimize unnecessary right ventricular pacing. This allows physicians to better tailor device programming for individual patient needs.