Medtronic has received CE mark for the Attain Stability Quad MRI SureScan left heart lead. The device offers active-fixation technology, designed for precise lead placement and stability.
The company has undertaken a limited European launch, with the first commercial implants performed at Haukeland University Hospital, Bergen, Norway.
“This new lead provides another option for left ventricular lead placement that can meet the needs of patients with various anatomies,” says Svein Faerestrand, Haukeland University Hospital. “We now have the ability to place the lead where we want within the vessel.”
The Attain Stability Quad lead is approved in CE-marked geographies for 3T and 1.5T magnetic resonance imaging (MRI) scans. It features a side-helix designed to be fixated precisely in veins of various sizes. Four electrodes are engineered to allow physicians flexibility in finding the optimal location for stimulating the heart.
Medtronic has initiated a global, prospective, non-randomised, multicentre clinical study to evaluate safety and effectiveness of the lead in heart failure patients. The study will enrol up to 471 patients across 56 sites in the USA, Canada, Europe, Hong Kong and Malaysia.
The primary efficacy endpoint will evaluate the number of patients that have appropriate pacing capture thresholds in ≥2 programming configurations. The primary safety endpoint is lead-related complication-free rate at six months. Co-principal investigators are Kevin Jackson, heart rhythm specialist at Duke Raleigh Hospital, Raleigh, USA, and assistant professor of medicine at Duke University, and George Crossley, III, associate professor of medicine and electrophysiologist at Vanderbilt Heart and Vascular Institute. Toshimasa Okabe recently performed the first implant in the clinical trial at Ross Heart Hospital of The Ohio State University Wexner Medical Center, Columbus, USA.
“LV lead positioning and stability remain a challenge for physicians,” says Jackson. “Acute and chronic lead dislodgement are still concerns. This lead’s active-fixation mechanism gives us another option to get to the desired pacing location, and stay there.”