FDA OKs quadripolar lead, 2 CRT-Ds

The FDA approved a quadripolar lead and two cardiac resynchronization therapy-defibrillator (CRT-D) devices for treatment in patients with heart failure.

According to device maker Medtronic, the newly approved Attain Performa Model 4298 quadripolar left-heart lead gives physicians more options by offering 16 pacing configurations. The lead has been shown to reduce the incidence of phrenic nerve stimulation.

The two Viva Quad devices—the XT and S CRT-Ds—incorporate different algorithms. The Viva Quad XT CRT-D uses the company’s AdaptivCRT algorithm, which in studies improved CRT response rate while reducing heart failure hospitalizations and readmission rates as well as the risk of atrial fibrillation. The Viva Quad S CRT-D integrates five algorithms.

Minneapolis-based Medtronic expects to make the lead and devices available in mid-September.