The FDA nod for Medtronic’s cardiac resynchronization therapy-pacemakers and cardiac resynchronization therapy-defibrillators is for patients with atrioventricular block and left ventricular systolic dysfunction, according to a press release.
The FDA approval follows a narrow win for Medtronic before an advisory panel last year. The Circulatory System Devices Panel, after reviewing data from the Block-HF clinical trial, voted 4-3 last October that the benefits of bi-ventricular pacing outweigh the risks.
"For patients with AV block and LV dysfunction, traditional [right ventricular] pacing may escalate the progression of heart failure," Block-HF lead investigator Dr. Anne Curtis of the University at Buffalo School of Medicine & Biomedical Sciences said in prepared remarks. "The Block-HF clinical trial provided strong clinical evidence validating the safety and efficacy of BiV pacing in this patient population."
"Medtronic is pleased with the FDA’s decision to expand the use of BiV pacing with Medtronic CRT-P and CRT-D devices in this new patient population," added Dr. David Steinhaus, Medtronic’s general manager for heart failure and medical director for its cardiac rhythm disease management business. "We have more than a decade of evidence showing that CRT improves quality of life for heart failure patients, and we now have also demonstrated improved outcomes for AV block patients with these devices, as well."