Medtronic lands FDA wins for new CRT-Ds and quadripolar lead

August 8, 2014 by Arezu Sarvestani

FDA regulators approve 2 new Medtronic CRT-Ds as well as a model of the Attain Performa quadripolar lead.

Medtronic lands FDA wins for new CRT-D and quadripolar lead

The Attain Performa quadripolar lead model 4298 and Viva Quad XT CRT-D

Medtronic (NYSE:MDT) is eying a broad September launch of its newly approved cardiac rhythm management devices, the Attain Performa quadripolar lead model 4298 and the Viva Quad XT and Viva Quad S cardiac resynchronization therapy defibrillators (CRT-Ds).

The new lead allows physicians to treat patients with 16 different pacing configurations and helps to prevent patients from developing phrenic nerve stimulation, a side effect of pacing that can result in muscle twitching, hiccups or shortness of breath, according to a Medtronic statement.

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Attain Performa leads have been on the market in the European Union since landing CE Mark approval in March 2013, back when Medtronic was still enrolling patients in its U.S. study. The FDA approval comes ahead of Medtronic's December 2014 estimate.

The Viva Quad CRT-Ds are part of a larger Viva line of defibrillators and pacemakers. They feature the AdaptivCRT  programming to detect and automatically adjust therapy to a patient's heart rhythms. Medtronic released data earlier this year on its AdaptivCRT devices, saying that the software helped reduce AF-related "healthcare utilizations" by more than half when compared with patients receiving conventional bi-ventricular pacing.