The U.S. Food and Drug Administration has granted approval to Impulse Dynamics NV's Optimizer Smart system to treat patients with chronic, moderate-to-severe heart failure who cannot use other devices.
According to the U.S. regulator, about 5.7 million people in the U.S. have heart failure, a condition in which the heart fails to pump enough blood to meet the body's need.
Optimizer Smart system uses a pulse generator implanted under the skin to deliver electrical impulses to the heart that improve its blood pumping capacity.
FDA's approval is based on results from two clinical trials with 389 patients with moderate to severe heart failures, where 191 received Optimizer Smart system implants. Results from the trials indicated improvements in distance covered during six-minute walking tests by patients with the implant along with improvements on assessments to measure heart failure symptoms.
The U.S. FDA had previously granted Optimizer Smart system a breakthrough device designation. Under the designation, the FDA provided intensive interaction and guidance to the company on efficient device development, to expedite evidence generation and the agency's review of the device.