FDA approves Percepta Quad CRT-P MRI SureScan, Serena Quad CRT-P MRI SureScan and Solara Quad CRT-P MRI SureScan for patients with heart failure- Medtronic

Medtronic has received FDA approval for a portfolio of quadripolar cardiac resynchronization therapy-pacemakers (CRT-Ps) that improve therapy delivery for patients with heart failure. These devices also allow patients to receive MRI (magnetic resonance imaging) scans in either 1.5 or 3 Tesla machines. The Percepta Quad CRT-P MRI SureScan, Serena Quad CRT-P MRI SureScan and Solara Quad CRT-P MRI SureScan are expected to be available commercially in the United States in early summer 2017.

The Percepta Quad CRT-P features the EffectivCRT Diagnostic, which automatically determines the effectiveness of each left ventricular pace, and the EffectivCRT during AF algorithm, which automatically adjusts pacing rates during atrial fibrillation. It also includes VectorExpress 2.0, an automated in-office test that reduces lead programing to two minutes, and reveals clinically actionable information to help physicians select optimal pacing configurations for each patient. The Percepta Quad and Serena Quad CRT-Ps also feature the Medtronic-exclusive AdaptivCRT algorithm, which reduces a patient's odds of a 30-day heart failure readmission by 59 percent, and has demonstrated a 46 percent reduction in AF risk compared to echo-optimized biventricular pacing. Multiple point pacing, which can stimulate the left ventricle (lower chamber) at two sites, is also available on both devices, as well as on the company's Claria MRI Quad CRT-D SureScan and Amplia MRI Quad CRT-D SureScan. All three CRT-Ps also are compatible with Attain Performa MRI SureScan Quadripolar Leads, which include short bipolar spacing to reduce the occurrence of phrenic nerve stimulation4, steroid on all electrodes, and three shapes for varying patient anatomies.