The US Food and Drug Administration (FDA) has granted approval to Medtronic’s Attain Stability Quad MRI SureScan left heart lead. The device is the only active-fixation left heart lead, and is designed for precise lead placement and stability.
Claimed to be the world’s first active fixation left heart lead, the new lead can be combined with Medtronic quadripolar cardiac resynchronisation therapy-defibrillators (CRT-D) and -pacemakers (CRT-P).
Meant for heart failure treatment, cardiac resynchronisation therapy (CRT) involves an implantable device that delivers low levels of energy via thin wires, called leads, to stimulate the heart muscle and enhance pumping efficiency.
Quadripolar leads are intended to allow physicians to pace from various sites in the heart, but are limited in where they can be placed.
Attain Stability Quad lead is said to integrate the benefits of a quadripolar lead with a side-helix, which allows fixation of the lead precisely in veins of different sizes.
Medtronic noted that the lead can also be placed in veins that are not usually amenable to positioning a passive lead.
Patients implanted with this lead and MR-conditional CRT devices will be able to undergo either 3Tesla (T) and 1.5T magnetic resonance imaging (MRI) scans.
The company is planning to commercially launch the new Attain Stability Quad MRI SureScan left heart lead over the coming months.
Medtronic Cardiac Resynchronization Therapy business vice-president and general manager Kweli Thompson said: “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 US, adding to our diverse portfolio of solutions for patients with heart failure.”
The company’s heart failure portfolio consists of MR-conditional CRT-Ds and CRT-Ps, mechanical circulatory support therapy, heart failure diagnostics and Medtronic Care Management Services.