FDA Approves St. Jude’s Quadripolar CRT-D Device Following Delay

05 Dec 2011

The approval is significant as it marks the entry of the first quadripolar pacing system into the U.S. market. But St. Jude may not get as big of a positive gain from the product as previously expected, analysts suggest.

St. Jude Medical Inc.’s Unify Quadra became the first cardiac resynchronization therapy defibrillator system with a quadripolar pacing lead approved by FDA Nov. 29, at least six months behind the firm’s initial target date.

The product represents an important technological advancement in the cardiac rhythm management space, and it is likely to give St....