MDT and CardioMEMS win dates with the FDA

October 19, 2011 by MassDevice staff

Medtronic and CardioMEMS will meet with the FDA's Circulatory Systems Devices Panel in December.


Medtronic Inc. (NYSE:MDT) and CardioMEMS have dates with the FDA.

The two med-tech companies will meet with the federal watchdog agency's circulatory systems devices panel on Dec. 7 and 8 to discuss the future of their products.

Med-tech goliath Medtronic will ask the FDA to expand the pre-market approval indications for all of its cardiac resynchronization therapy defibrillators. The Minneapolis-based company landed PMA approval for its Concerto, Insync Sentry and Insync Maximo defibrillators in August.

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Medtronic is already slated to meet with the circulatory system advisory panel Oct. 27 for a review of its pre-market approval application for the Ablation Frontiers cardiac ablation system.

On Dec. 8, CardioMEMS' HF pressure measurement system will be reviewed by the medical devices advisory panel.

CardioMEMS system measures daily pulmonary artery pressure in patients who have suffered congestive heart failure.

Last year, St. Jude Medical Inc. (NYSE:STJ) spent $60 million on an equity stake in CardioMEMS, giving the med-tech giant a 19 percent stake in the country.