FDA Approves Attain Stability Quad MRI SureScan Lead from Medtronic

May 6, 2019 — Medtronic has received U.S. Food and Drug Administration (FDA) approval for the Attain Stability Quad MRI SureScan left heart lead. Paired with Medtronic quadripolar cardiac resynchronization therapy-defibrillators (CRT-D) and -pacemakers (CRT-P), the Attain Stability Quad lead is the only active-fixation left heart lead, according to the company, and is designed for precise lead placement and stability. The lead will be commercially available in the U.S. in summer 2019.

"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," said Steven Zweibel, M.D., F.A.C.C., F.H.R.S., C.C.D.S., director of electrophysiology at the Hartford Healthcare Heart and Vascular Institute (Conn.).

CRT is a treatment for heart failure in which an implantable device sends low levels of energy through thin wires, called leads, to stimulate the heart muscle and potentially improve the heart's pumping efficiency. With the introduction of quadripolar leads (leads with four electrodes), physicians can pace from different locations in the heart, but are limited in where they can place the lead. The Attain Stability Quad lead integrates the benefits of a quadripolar lead with a side-helix that allows physicians to fixate the lead precisely in veins of various sizes, including ones not typically amenable to positioning a passive lead. Additionally, patients with this lead and MR-conditional CRT devices are eligible for either 3 Tesla (T) and 1.5T magnetic resonance imaging (MRI) scans, if needed.

For more information: www.medtronic.com