First active-fixation left heart lead approved by FDA

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Attain Stability Quad MRI SureScan left heart lead

The US Food and Drug Administration (FDA) has granted approval to Medtronic for the Attain Stability Quad MRI SureScan left heart lead. It is the only active-fixation left heart lead, and is designed for precise lead placement and stability, paired with Medtronic quadripolar cardiac resynchronisation therapy-defibrillators (CRT-D) and pacemakers (CRT-P) to treat heart failure.

A press release from the company explains that 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. Additionally, patients with this lead and magnetic resonance (MR)-conditional CRT devices are eligible for either 3 Tesla (T) and 1.5T magnetic resonance imaging (MRI) scans, if needed.

Steven Zweibel, director of Electrophysiology at the Hartford Healthcare Heart and Vascular Institute, comments in the press release: “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.”

The lead will be commercially available in the USA in summer 2019.

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