Medtronic secures CE Mark for MRI device

Medtronic has received the CE Mark for its Attain Stability Quad MRI SureScan left heart lead.

The device is approved for 3- and 1.5-tesla MRI scans and features a side helix designed to be fixated precisely in veins of various sizes.

First commercial implants in Europe recently were performed at Haukeland University Hospital in Bergen, Norway.

In the U.S., the Attain Stability Quad lead is under evaluation in a clinical trial and is not approved for sale.

In other Medtronic news, the firm initiated a global, prospective, nonrandomized, multicenter clinical study to evaluate the safety and effectiveness of the lead in heart failure patients. The study will enroll up to 471 patients across 56 sites in the U.S., Canada, Europe, Hong Kong, and Malaysia. The study will evaluate the number of patients who have appropriate pacing capture thresholds in at least two programming configurations, and the primary safety end point is lead-related complication-free rate at six months.

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