SynCardia wins FDA trial OK
by Curtis Gunn on April 1st, 2010 at 2:54pm
The U.S. Food and Drug Administration approved a clinical trial called an Investigational Device Exemption study for a Tucson company’s portable power source for artificial hearts.
The FDA uses IDE studies to collect safety data in order to approve devices for the market.
The Tucson-based SynCardia Systems, Inc.-manufactured Freedom driver system will allow heart patients to leave the hospital as they await their transplants rather than be stuck in hospital rooms to giant, immobile drivers.
As soon as two weeks from now, as many as 60 patients from around the country will be selected to use the driver.
The study will follow the patients until 90 days after they’re discharged from the hospital following their heart transplants. The study, initiated by SynCardia to gain the FDA’s approval, will be jointly conducted by various medical centers around the country.
A SynCardia spokesman said the study could be completed by the end of the year. At that point, the FDA will be able to evaluate the study and whether to give final approval to the Freedom driver.
Currently American patients awaiting heart transplants are tethered to 418-pound drivers called Big Blue and can’t leave the hospital.
The Freedom driver, which weighs 13.5 pounds and fits into a backpack or shoulder bag, will let patients return to regular life. Batteries run two to three hours, and patients can plug the driver into the wall as they sleep and into a vehicle’s cigarette lighter as they travel.
The driver connects to the artificial heart via two tubes that enter the body through the abdominal wall.
The Freedom driver has been in development for 10 years, said SynCardia co-founder and chief technical officer Rich Smith, who manages the project.
Smith, an engineer who works in tandem with cardiologists and surgeons to treat heart patients at University Medical Center, said the device will eventually free up hospital rooms, cut costs for patients and allow medical professionals to give more attention to more patients.
SynCardia CEO Rodger Ford anticipates expanding the business, creating more jobs in Tucson.
Contact reporter Phil Villarreal at 573-4130 or pvillarreal@azstarnet.com
Reported in Arizona Daily Star
