Tucson: Synardia Expects Production Increase

Heart device would free patients

Tucson firm awaits FDA approval on 12-lb. pump for artificial ticker

By Stephanie Innes

ARIZONA DAILY STAR

A Tucson company founded by two local doctors and a biomedical engineer expects to significantly in­crease its production of tem­porary artificial hearts.

SynCardia Systems, founded in 2001, has provid­ed total artificial hearts for implants in 380 patients. The company’s CardioWest heart is the only total artificial heart as a temporary bridge to a human-donor transplant that’s been approved by the U.S. Food and Drug Adminis­tration. It also has the ap­proval of Health Canada and the European Union’s CE mark.

The company has devel­oped a new, portable power supply to keep those artificial hearts pumping, which is ex­pected to dramatically in­crease the number of pa­tients who receive them, company officials said at a news conference Thursday.

Patients with one of the company’s CardioWest total artificial hearts are now re­quired to be attached to a “Big Blue” — a 400-plus­pound driver similar in size to a washing machine that keeps the heart pumping. Every patient must also have a Big Blue backup in case of malfunction.

The driver is an external compressed-air device that makes the artificial device pump blood like a human heart.

The new “Freedom” driv­er, developed over the last two years, weighs just 12 pounds and may be carried around like a shoulder bag. That means that patients, rather than spending months in a hospital attached to the Big Blue while waiting for a donor heart, may wait at home, said Dr. Jack Copeland, chief of cardio­thoracic surgery at Universi­ty Medical Center.

The Freedom is different from a 20-pound power driver the company had de­veloped and considered get­ting approved in 2006; those plans were later scrapped.

Copeland and other com­pany officials hope the Free­dom will be approved for use by the FDA this year. The company says it will submit the product for approval this summer, though officials would not be more specific. In the best-case scenario, the product would be approved after30days.

“Waiting for a transplant outside the hospital liberates the patient,” said Copeland, who is one of SynCardia’s co-founders. “The body can’t tell the difference be­tween the big and small driv­er, but, mentally for the pa­tient, being at home can help. Nutrition and exer­cise are very important, and those things can improve at home, too.”

The new portable devices are also expected to save the expense of keeping patients in the hospital while they wait.

Only 36 Big Blues exist. Since each patient must have a backup driver, that means only 18 are in use at any time, SynCardia President and CEO Rodger Ford said. The company spent a half-mil­lion dollars in shipping charges alone last year, send­ing the cumbersome devices around the world.

“Big Blue is going away. It’s stable — good and solid. But it’s like a tank, and we want a sports car,” Ford said.

He said the company hopes to have hundreds of Freedoms hooked up to patients around the world. The Freedoms power up in a way that’s simi­lar to a mobile phone — they can be recharged with elec­tricity and may operate on batteries, meaning they don’t need to be connected to a power supply.

Patients may go to the mall or restaurants on their own.

Vanessa Cirillo says she would have benefited from the Freedom in 2007, while she was in UMC with a Cardio­West artificial heart and wait­ing for a human-donor heart. She ended up spending more than four months in the hos­pital.

During the wait, an en­gineer pushed her Big Blue as she walked around the hospi­tal.

Cirillo, 29, said once she re­ceived the artificial heart she felt better than she’d felt in years.

“I wanted to go home,” she said. “The hospital became my home. ... I was getting mail at the hospital. Going home would have changed my men­tal status about the trans­plant.”

The temporary total artifi­cial hearts are crucial to many patients who are dying from end-stage biventricular fail­ure and are waiting for hu­man- donor hearts. In the U.S., 47 percent of people listed for a donor heart have been waiting for more than a year; 15 percent have been waiting more than five years.

Contact reporter Stephanie Innes at 573-4134 or sinnes@azstarnet.com.