Medtronic says FDA warning letters resolved

Medtronic Inc said on Wednesday it resolved two warning letters issued by U.S. health regulators in 2009, clearing the way for new product approvals.

With the resolution of issues raised in the warning letters, Medtronic can move forward with products that have received “approvable letters.” An approvable letter from the agency classifies a device as approvable pending additional requirements.

The company has highlighted two of these products as key to near and long-term growth, noted Leerink Swann analyst Rick Wise.

One of the two products is Protecta, a cardiac resynchronization therapy implantable cardioverter defibrillator, known as CRT-D. It uses algorithms to minimize inappropriate shocks, while providing defibrillation shock therapy when needed.

The second product is its InterStim Therapy for Bowel Control, a new treatment for patients suffering from severe chronic fecal incontinence who have exhausted nonsurgical treatment alternatives. The device uses a sacral nerve stimulation system.

Shares of the world’s largest maker of medical devices rose by as much as 1.5 percent in early trading before paring gains. They were up 20 cents to $39.82 on the New York Stock Exchange around midday.

Medtronic received a warning letter from the U.S. Food and Drug Administration in November 2009 about the company’s Mounds View, Minnesota, facility and another in June 2009 about its manufacturing facility in Juncos, Puerto Rico.

The FDA letter for the Mounds View facility, which serves as the headquarters of its Cardiac Rhythm Disease Management business, came after an inspection the previous August.

The letter for the facility in Juncos, which is a manufacturing location for the Neuromodulation, Diabetes and Cardiac Rhythm Disease Management businesses, followed an inspection the prior December.

“Though the exact timeline to final approval is still uncertain, it seems likely that Medtronic could be in a position to launch these new products in early fiscal year 2012 at the latest,” Leerink Swann’s Wise wrote in a note to clients.

“Medtronic believes its Protecta ICD could help alleviate some pricing pressure going forward, in addition to helping the company maintain—or best case gain—ICD market share in the U.S.,” he added.

Medtronic also has an approvable letter for Consulta/Syncra, a CRT-P cardiac resynchronization therapy pacemaker and its Attain Ability Plus, a steroid eluting dual electrode, left ventricular cardiac vein lead.

(Reporting by Debra Sherman; Editing by Gerald E. McCormick, Matthew Lewis and Steve Orlofsky)

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(Reuters)