This article is more than 5 years old. Information may no longer be current.
FDA approves two left ventricular quadripolar leads for CRT-Ds
Click Here to Manage Email Alerts
Medtronic recently announced that it has received FDA approval of two left ventricular quadripolar leads for use with cardiac resynchronization therapy defibrillators in patients with HF.
The S-shape and Straight Attain Performa LV leads are intended for use with the Medtronic Viva Quad XT and Quad S CRT-Ds by patients with HF. The leads are intended to accommodate vessels and curvatures of various sizes to improve placement, according to a press release.
The approvals followed results from a multicenter study of 1,201 patients, presented at the American Heart Association Scientific Sessions, which assessed the safety and efficacy of the leads. Researchers observed an implant success rate of 97.6%, a low complication rate, and low and stable pacing capture thresholds up to 6 months for all pacing polarities. The study included the S-shape and Straight leads, along with the Attain Performa Dual Cant model, which was approved by the FDA in August, according to the release.
George H. Crossley
“While optimal lead positioning has been shown to improve CRT response rates, every patient is different, making lead placement and stability a common challenge that can result in nonresponse to therapy,” George H. Crossley, MD, FACC, FHRS, associate professor at Vanderbilt Heart and Vascular Institute in Nashville, Tenn., stated in the release. “Having access to a range of lead shapes that work with one CRT-D system gives physicians the ability to help our HF patients, even if their cardiac anatomy is challenging.”