Medtronic won CE Mark approval to introduce its Attain Stability Quad MRI SureScan left heart lead in Europe. The device works with the company’s quadripolar cardiac resynchronization therapy-defibrillators (CRT-D) and CRT-pacemakers (CRT-P) and is not only a conduit for electric current, but also a tool for the electricity to better target cardiac tissue.
The device features a helix that works kind of 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.
The device is currently undergoing a clinical trial in the U.S. in preparation for regulatory acceptance and Medtronic already has a prospective trial in the works. According to the company:
The study will enroll up to 471 patients across 56 sites in the United States, Canada, Europe, Hong Kong and Malaysia. The primary efficacy endpoint will evaluate the number of patients that have appropriate pacing capture thresholds in at least two programming configurations, and the primary safety endpoint is lead-related complication-free rate at six months. Co-principal investigators are Kevin Jackson, M.D., heart rhythm specialist at Duke Raleigh Hospital, and assistant professor of medicine at Duke University, and George Crossley, III, M.D., associate professor of medicine and electrophysiologist at Vanderbilt Heart and Vascular Institute. Toshimasa Okabe, M.D., recently performed the first implant in the clinical trial at Ross Heart Hospital of The Ohio State University Wexner Medical Center.