FDA approval for Attain Stability Quad MRI SureScan left heart lead designed for precise lead placement and stability

Medtronic plc has announced it has received 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, 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.

The device features a helix that works like an anchor to secure the lead, adapting to whatever size anatomy each individual patient has. The four electrodes give multiple options for how to stimulate the heart, helping to achieve optimum efficiency and therapy outcomes. The lead is also safe for use during whole body MRI scans of both 1.5 and 3.0 Tesla, as long as certain precautions are taken. Combined with MRI-conditional electronic implants allows patients to continue receiving MRI scans, an important factor when considering continued medical care.

Comment: Medtronic received CE Mark for the Attain Stability Quad MRI SureScan left heart lead on 22 August 2017.