Medtronic (NYSE:MDT) said today it won FDA approval for its Attain Stability quad MRI SureScan left heart lead, touting it as the only active-fixation left heart lead on the market.
The newly cleared Attain Stability left heart leads are meant to be paired with the Fridley, Minn.-based company’s quadripolar cardiac resynchronization therapy-defibrillators and pacemakers, and feature an improved design intended to improve lead placement and stability.
The Attain Stability quad leads are equipped with a side-helix to allow precise fixation in veins of various sizes, including ones not typically amenable to positioning a passive lead, the company said.
“Appropriate placement of left heart leads during implantation of CRT devices is critical to achieve the clinical benefits of this therapy. Unfortunately, with present passive-fixation leads, we are not always able to position the lead in an ideal location due to variations in a patient’s anatomy and size of the target vessel. We also continue to see lead dislodgements that require reprogramming or repeat surgery for lead repositioning. Having a new active fixation left heart lead allows us to target the ideal location in the patient’s vessel with the confidence that the lead will remain in place to allow for continued effective delivery of CRT,” Dr. Steven Zweibel of the Hartford Healthcare Heart and Vascular Institute said in a prepared statement.
Medtronic said that it expects the leads to be available on the U.S. market this summer.
“Clinical trial evidence shows this lead is a safe and effective option for patients receiving CRT devices. It offers the advantages of established quadripolar leads, while enabling secure placement across various patient anatomies. We are pleased to bring the latest advancement in left-heart lead technology to the U.S., adding to our diverse portfolio of solutions for patients with heart failure,” cardiac resynchronization therapy biz GM Dr. Kweli Thompson said in a press release.
Yesterday, Medtronic said that it launched its Solitaire X revascularization device intended for treating acute ischemic stroke in the U.S.