Artificial heart maker SynCardia announced this week that it won FDA approval for its Freedom driver, a portable power driver that allows patients to take their artificial heart systems out of the hospital.
The company expects the technology to be a major cost-savor in healthcare as it could dramatically cut most in-hospital costs for heart transplant patients who are otherwise bound to the clinic while they await a donor heart.
The battery-powered Freedom driver weighs less than 14 pounds and can be toted around in a shoulder bag, backpack or rolling bag designed for the system.
"These patients can be discharged and live in their homes and communities while they wait for their matching donor hearts," SynCardia president & CEO Michael Garippa said in prepared remarks. "We anticipate that this will save patients, hospitals and insurance companies thousands of dollars through eliminating most in-hospital costs for this portion of patient care."
The FDA win is a major one for the Arizona-based company, which is also pursuing approval for the SynCardia total artificial heart as a destination therapy rather than just a bridge to transplant. The company late last year also raised $14 million to support efforts to develop a smaller artificial heart system.