Medtronic has secured approval from the US Food and Drug Administration (FDA) for its Attain Stability Quad MRI SureScan left heart lead.
Image: The FDA has approved Medtronic’s Attain Stability Quad MRI SureScan left heart lead. Photo: courtesy of Medtronic.
Combined with Medtronic quadripolar cardiac resynchronization therapy-defibrillators (CRT-D) and -pacemakers (CRT-P), Attain Stability Quad MRI SureScan is claimed to be the world’s first quadripolar active fixation left heart lead.
Cardiac resynchronization therapy (CRT) is a heart failure treatment, under which an implantable device sends low levels of energy via thin wires, known as leads, to stimulate the heart muscle and enhance the heart’s pumping efficiency.
The quadripolar leads enables physicians to pace from different locations in the heart, but are limited in where they can place the lead.
Attain Stability Quad lead is said to incorporate the benefits of a quadripolar lead with a side-helix, which allows physicians to fixate the lead precisely in veins of various sizes, including ones not typically amenable to positioning a passive lead.
Patients with this lead and MR-conditional CRT devices can also undergo either 3 Tesla (T) and 1.5T magnetic resonance imaging (MRI) scans, if required.
The company plans to commercially launch the Attain Stability Quad lead in summer this year.
Medtronic cardiac rhythm and heart failure division’s cardiac resynchronization therapy business general manager and vice president Dr 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 U.S., adding to our diverse portfolio of solutions for patients with heart failure.”
Medtronic portfolio of therapies, diagnostic tools and services to treat patients with heart failure comprise of MR-conditional CRT-Ds and CRT-Ps, mechanical circulatory support therapy for advanced heart failure patients, heart failure diagnostics and meaningful expert analysis via Medtronic Care Management Services.
Based in Dublin of Ireland, Medtronic provides a range of advanced medical technologies for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias.