FDA clears world’s 1st active-fixation left heart lead

The FDA on May 1 announced it cleared Medtronic’s Attain Stability Quad MRI SureScan left heart lead for commercial use in the U.S.

The Attain Stability Quad lead is the only active-fixation left heart lead on the global market today, according to Medtronic, and will be available in the U.S. starting this summer. The lead is designed to pair with quadripolar cardiac resynchronization therapy (CRT) defibrillators and pacemakers to for more accurate placement of implantable devices.

“Appropriate placement of left heart leads during implantation of CRT devices is critical to achieve the clinical benefits of this therapy,” Steven Zweibel, MD, the director of electrophysiology and the Hartford Healthcare Heart and Vascular Institute, said in a release from Medtronic. “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. 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.”

The tech will also hopefully cut down on lead dislodgements that require reprogramming or repeat surgery for lead repositioning, he said.

According to Medtronic, the Attain Stability Quad lead integrates the benefits of quadripolar leads—leads with four electrodes that physicians can pace from different locations in the heart—with a side-helix that allows doctors to fixate the lead more precisely in differently sized veins. Clinical studies found the lead facilitated implantation even in veins that aren’t typically amenable to passive lead positioning.

In addition, patients who use the new lead with magnetic resonance-conditional CRT devices are eligible for 3T and 1.5T MRI scans if needed.

“Clinical trial evidence shows this lead is a safe and effective option for patients receiving CRT devices,” Kweli P. Thompson, MD, MPH, of Medtronic, said in the release. “It offers the advantages of established quadripolar leads while enabling secure placement across various patient anatomies.”