Impulse Dynamics has set a date with the FDA’s Circulatory System Devices Panel, part of the agency’s Medical Device Advisory Committee, discussing the premarket application for the company’s Optimizer Smart impulse generator device.
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 Stuttgart, Germany-based company will meet with the panel on December 4 and 5.
The panel will be seeking input “regarding the potential indications and labeling for devices intended to treat hypertension and optimal study designs needed to evaluate the potential benefits and risks while considering issues such as medication compliance, patient perspective, and appropriate study controls,” according to an FDA posting.
Last May, Impulse Dynamics said that it closed a $45 million equity financing round to support its cardiac contractility modulation technology designed to treat chronic heart failure.
