St. Jude targets FDA approval for next-gen CRT-D

St. Jude is working toward FDA approval for Quadra Assura MP.--Courtesy of St. Jude

St. Jude Medical ($STJ) is kicking off a large-scale study of its next-generation Quadripolar Pacing System, seeking FDA approval for a device the company says could improve outcomes for patients who don't respond to standard treatment.

The trial will enroll more than 500 patients at 50 centers in the U.S., St. Jude said, studying the Quadra Assura MP CRT-D in heart failure sufferers who get little benefit from existing cardiac resynchronization therapies.

St. Jude's device, paired with the Quartet lead, can deliver two left ventricular pacing pulses at the same time, helping it treat a larger area of the cardiac anatomy, and the study will determine whether Quadra Assura's expanded scope can make a difference for patients with few other options.

"The Quadra Assura MP device builds upon the robust platform available with the current St. Jude Medical quadripolar technology and provides additional tools that may improve the CRT responder rate even further," St. Jude CMO Mark Carlson said in a statement. "This study represents our commitment to investing in product innovation and clinical evidence to ensure an increasing number of patients continue to respond to, and appropriately benefit from, CRT."

St. Jude won a CE mark for the device back in November, touting it as delivering the most energy of any CRT-D on the market while minimizing unnecessary shocks through the company's ShockGuard technology.

If St. Jude can demonstrate Quadra Assura's benefits over standard therapy and get its device on U.S. shelves, it has a chance to reach the nearly 5 million Americans who suffer from heart failure and pad its flagging cardiac revenues with an in-demand implant.

Last quarter, the company's cardiac rhythm management business slid 8%, fueled by a 12% drop in pacemaker sales. And while St. Jude is still counting on company-wide growth in 2013, CFO John Heinmiller said the company expects CRM revenues to decline about 4% on the year.

- read the announcement

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