Medtronic receives FDA approval and launches additional Attain Performa leads


The US Food and Drug Administration (FDA) has approved commercial launch of two additional Attain Performa left ventricular quadripolar leads, which can be paired with the Medtronic Viva Quad XT and Viva Quad S cardiac resynchronisation therapy defibrillators (CRT-D) to treat patients with heart failure.

The newest additions to the Attain Performa lead portfolio, the S-shape and Straight leads, are designed to accommodate patients’ varying vessel sizes and curvatures to enhance successful lead placement.

FDA approval for the additional quadripolar leads follows the August 2014 approval of the Attain Performa Model 4298 Dual Cant quadripolar lead. All three leads were studied in the multicentre Attain Performa clinical study, involving more than 1,200 patients. Results featured at the 2014 American Heart Association Scientific Sessions demonstrate an implant success rate of 97.6%, and show that CRT with the Attain Performa family of LV quadripolar leads is associated with a low complication rate, and low, stable pacing capture thresholds (PCTs) through six months for all pacing polarities.

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

All three Attain Performa leads are compatible with the company’s newest portfolio of CRT devices, the Viva Quad XT and Viva Quad S CRT-D systems. The Viva Quad XT CRT-D features the Medtronic-exclusive AdaptivCRT algorithm, which, according to a company release, significantly improves heart failure patients’ response rate to therapy by preserving normal heart rhythms and automatically adapting to patient needs, creating a customised therapy for each patient.