St. Jude Revises Timeline For Quadripolar CRT-D Device

St. Jude Medical now hopes for FDA approval of its highly-anticipated Unify Quadra quadripolar cardiac resynchronization therapy defibrillator system by year-end, an update from initial company expectations for a mid-year U.S. launch.

Speaking during St. Jude’s July 20 second-quarter earnings call, CEO Daniel Starks downplayed the significance of the delay on the pending PMA supplement for the four-electrode CRT-D device.

“Based on our ongoing communications with FDA, that’s our current expectation,” Starks said. “This is just an example of the uncertainty associated with any regulatory process and I would not read anything else into it.”

The product is already approved in Europe, and has been received favorably there, Starks added.

Because the left-ventricular lead in the Quadra system contains two additional electrodes compared to standard bipolar leads, it offers electrophysiologists more flexibility in lead placement. This could potentially lead to a lower incidence of dislodgement and other adverse events, and even may improve therapy response rate.

“When we get it here in the United States, we would have a lot of confidence and optimism that it will have a very meaningful impact,” Starks said.

While both Medtronic and Boston Scientific have quadripolar leads in the pipeline, they are believed to be a year or more behind St. Jude’s development cycle.

When Will St. Jude Buy CardioMEMS?

St. Jude says Unify Quadra is among several of the firm’s most important growth drivers. During the conference call, Starks gave updates on one of the others – the CardioMEMS implantable hemodynamic sensor. (See “ "St. Jude Announces Key Approvals On Top Of Q1 Results" — "The Gray Sheet," Apr. 25, 2011 ” – “The Gray Sheet” April 25, 2011.)

The CEO said St. Jude expects the CardioMEMS PMA to face FDA panel review this fall, with approval and a full U.S. launch in 2012.

St. Jude, which holds a 19% ownership stake in Atlanta-based manufacturer CardioMEMS and an option to buy the firm outright, may be gearing up in the next few months to acquire the remainder of the company.

“Our arrangement with CardioMEMS permits us to exercise our option and close on our acquisition of CardioMEMS before FDA approval,” Starks explained. “We will do everything that makes sense here to make sure we can fully leverage, in an urgent way, the value of the CardioMEMS technology following a positive panel meeting.”

St. Jude has said it sees a multi-billion-dollar market potential for the CardioMEMS wireless transmitting device, which is used to closely monitor heart failure patients to spot new treatment needs before a patient’s health declines to the point where hospitalization is required. (See “ "St. Jude: CardioMEMS’ Heart Failure Data Reflects Major Opportunity" — "The Gray Sheet," Feb. 14, 2011 ” – “The Gray Sheet” Feb. 14, 2011.)

Q2 Results Mixed

St. Jude reported more than $1.4 billion in net sales during its second quarter, up 10% from the prior-year period.

But the results reflect persistent market challenges, industry analysts suggest. The firm reduced its full-year 2011 earnings guidance by 4% “to reflect ongoing pressure in the market,” Morgan Stanley analyst David Lewis pointed out.

St. Jude’s cardiac rhythm management division, including implantable cardioverter defibrillators and pacemakers, reported $793 million in sales during the quarter, up just 1% compared to the same period in 2010. The number is slightly higher after adjusting for the one-time benefit of Boston Scientific’s ICD product sales suspension in the U.S. in 2010.

The company’s ICD product sales reached $477 million, up 1%, or 5% when the one-time benefit is factored in. Pacemaker sales in the second-quarter remained flat at $316 million.

Atrial fibrillation product sales, however, jumped to $208 million, 18% higher than the prior-year period.

Cardiovascular sales, including vascular and structural heart products, climbed to $342 million during the quarter, up 35% compared to 2010, aided by the company’s 2010 acquisition of AGA Medical. (See “ "AGA Purchase Gives St. Jude Structural Heart Leadership, Growth Potential" — "The Gray Sheet," Oct. 25, 2010 ” – “The Gray Sheet” Oct. 25, 2010.)

By Mark Hollmer