- The FDA has approved Medtronic’s Claria MRI Quad Cardiac Resynchronization Therapy Defibrillator SureScan device for patients with heart failure.
- The CRT-D SureScan can be used for scanning 1.5 and 3 Tesla MRIs and features an algorithm that automatically adjusts pacing rates for individual patients.
- A large percentage of heart failure patients who get CRT have atrial fibrillation, which can impede a patient’s response to CRT, according to Medtronic. The Claria device is designed to detect and adjust pacing rates during episodes of AF.
“Until now, CRT devices have shown only whether a pacing pulse was sent, but we haven’t been able to determine if that stimulation actually improves the heart’s pumping ability,” Suneet Mittal, director of the electrophysiology laboratory at Valley Health Systems’ Arrhythmia Institute in New Jersey, said in a statement.
The approval comes as CMS is proposing Medicare coverage for leadless pacemakers when used in federally approved clinical studies, Modern Healthcare reports. The agency said more evidence is needed before nonconditional reimbursement is granted. Medtronic’s Micra Transcatheter Pacing System, approved by the FDA in April, is the only currently available leadless pacemaker.
Medtronic announced in June that it was acquiring HeartWare for $1.1 billion, a deal that would expand its current portfolio of diagnostics, therapies and services for heart failure patients. It is the second medical device acquisition for Medtronic, following its 2015 purchase of Covidien.
Meanwhile, a Texas jury found Medtronic guilty of infringing two patents held by a physician for devices that align vertebrae in patients with scoliosis, and ordered the company to pay $20.3 million in damages, Law360 reports.