FDA Approves Two New Medtronic CRT Quad Leads

The FDA has approved Medtronic and it is making two Performa left ventricular quadripolar leads available for use with Viva Quad XT and Viva Quad S cardiac resynchronization therapy defibrillators (CRT-D). The leads now offer more options for placement dur to the newly approved S and straight shaped devices in addition to the previously approved Dual Cant Model 4298 being available. The leads allow for sixteen different pacing configurations with their four electrodes. From Medtronic

Accommodation of various anatomies without compromising lead handling or stability is the reason for the three Attain Performa lead shapes -Dual Cant Model 4298, Straight Model 4398 and S-Shape Model 4598. With 16 pacing configurations and shorter spacing between the two center electrodes, the quadripolar leads have been shown to reduce the incidence of phrenic nerve stimulation (PNS), which is a potential issue associated with CRT therapy that results in muscle twitching, hiccups or shortness of breath. Greater device longevity and reduce the likelihood of PNS is possible as Attain Performa leads also include steroid elution on all four electrodes for lower chronic pacing thresholds.

All three Attain Performa leads are compatible with the Viva Quad XT and Viva Quad S CRT-D systems, the company’s newest portfolio of CRT devices. The Viva Quad XT CRT-D features the Medtronic-exclusive AdaptivCRT algorithm, which significantly improves heart failure patients’ response rate to therapy by preserving normal heart rhythms and automatically adapting to patient needs, creating a customized therapy for each patient. AdaptivCRT is the only algorithm demonstrated to improve heart failure patients’ response to the therapyiv (as compared to conventional biventricular therapy) and reduce the risk of atrial fibrillation (AF).

Source-Medindia