Devices & Diagnostics

St. Jude’s long-awaited Unify Quadra CRT-D wins FDA approval

St. Jude Medical Inc. (NYSE:STJ) yesterday announced U.S. Food and Drug Administration approval of its highly anticipated Unify Quadra cardiac resynchronization therapy defibrillator (CRT-D) and Quartet Left Ventricular Quadripolar Pacing Lead. This is the industry’s first quadripolar pacing system, which the St. Paul, Minnesota-based medical device maker says allows cardiologists to better manage CRT. Defibrillators […]

St. Jude Medical Inc. (NYSE:STJ) yesterday announced U.S. Food and Drug Administration approval of its highly anticipated Unify Quadra cardiac resynchronization therapy defibrillator (CRT-D) and Quartet Left Ventricular Quadripolar Pacing Lead.

This is the industry’s first quadripolar pacing system, which the St. Paul, Minnesota-based medical device maker says allows cardiologists to better manage CRT.

Defibrillators are implanted in the chest and usually connected to the heart with leads, synchronizing the heart’s lower chambers — which are often out of sync in heart failure patients — so they are more efficient in pumping blood to the body. The Quadra and Quartet use a pacing lead with four electrodes, which enables more pacing configurations and reduces common problems associated with implantable CRT systems, and ultimately results in fewer surgeries for patients.

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“Based on the clinical experiences and publications to date, this innovative CRT system has the potential to redefine the standard of care in resynchronization therapy for heart failure patients around the world,” said Dr. Eric S. Fain, president of the St. Jude Medical Cardiac Rhythm Management Division, in a statement.

Analysts agree. They expressed excitement over the pending U.S. launch of the Quadra earlier this year, and in March, J.P. Morgan analyst Michael Weinstein called it the most important new product in the space since 2002, which caused St. Jude shares to surge 6 percent.

Weinstein surveyed 50 cardiologists and found that 92 percent of them expected the type of lead system used in the Quadra to become the standard of care.

Upon news of the approval, Morgan Keegan reiterated its Outperform rating and $53 target price for St. Jude, saying, “This should be a strong positive for St Jude’s CRT-D business, and when combined with the accelerating replacement cycle, should allow the company to continue to take share from competitors Boston Scientific Corp. and Medtronic Inc. — the European experience has been positive.” Canaccord maintained its hold rating and $42 target. St. Jude stocks were up 6 percent this morning.

But not everyone is so optimistic. ICD competitor Boston Scientific’s CEO Ray Elliot trashed the product in May, and called it “99 percent hype.”

About 2 million new cases of congestive heart failure are diagnosed each year, but the market for ICDs has slumped in the past year following a controversial report and proceeding U.S. Department of Justice investigation of overuse of the devices.

Market competitors Medtronic and Boston Scientific have suffered in ICD sales, too. Both device makers are developing similar lead technology, but are reportedly at least 18 months behind St. Jude.

The Quadra should boost St. Jude’s share in the defibrillator market. An earlier version, Promote Quadra CRT-D, was approved in India in September and in Europe in May 2010. The company said it will begin shipping the products in the U.S. immediately.