FDA panel votes in support of Impulse Dynamic ’ s cardiac contractility modulation pulse generator

The FDA’s Circulatory Systems Device Panel this week voted in favor of Impulse Dynamics’s Optimizer Smart implantable pulse generator, supporting the company’s premarket approval application seeking clearance for use in patients suffering from heart failure, according to a Healio report. The Optimizer impulse generator is designed to remodel the myocardium to increase the heart’s efficiency using what the company calls the cardiac contractility modulation – non-excitatory electrical pulses delivered to the heart muscle. The system has had CE Mark approval in the European Union for the device since 2002. The FDA’s Circulatory Systems Device Panel voted 12 to 1 in favor of the device’s safety and 11 to 2 in favor of its efficacy, according to Healio. The panel also voted 12 to 0, with a single abstention, that benefits of the device outweighed the risks. The device came supported by safety and efficacy evidence from the 418-patient FIX-HF-5 study of the device, which compared treatment with CCM to guideline-directed medical therapy for heart failure patients, according to the report. The trial’s primary safety endpoint was defined as a composite event rate of all-cause hospitalizations and all-cause mortality through 50 weeks, which was reported at 4.9% in the CCM treatment arm and 3.3% in the control arm, according to Healio. No deaths were reported as caused by the implant procedure or the device, and rates of events that required invasive treatment or hospita...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Impulse Dynamics Source Type: news