CardioWest™ Artificial Heart Patient Loses 430 lbs

TUCSON, Ariz.--(BUSINESS WIRE)--On Oct. 22, CardioWest temporary Total Artificial Heart patient Mr. Potiron shed 430 lbs when he was switched to the 20-lb CE-approved portable driver after nearly a year of support on the 450-lb hospital driver “Big Blue” at University Hospital of Nantes.

“I wouldn’t be here today if it weren’t for the CardioWest artificial heart,” said Mr. Potiron. “I am very grateful for my second chance at life. However, it has been difficult for me over the past year because I’ve been pushing around an extra 450 lbs. Now with the portable driver, I can go for a walk in the park, buy a newspaper and get a drink at the cafeteria.”

“In some European countries, artificial heart patients can wait up to two years for a matching donor heart,” said Prof. Daniel Duveau, the medical director for University Hospital of Nantes and a CardioWest certified proctor. “Even though Mr. Potiron is stable and doing well, the 450-lb hospital driver that powered his artificial heart during surgery and recovery limited his mobility. Now that he is using a portable driver, his quality of life has improved dramatically.”

“We have waited for a long time to put one of our patients on the portable driver because it is in limited supply,” said Prof. Duveau. “If we had a back-up portable driver for Mr. Potiron, we would be able to discharge him to wait at home for a matching donor heart. We eagerly await the arrival of the new Companion Driver System so that more of our artificial heart patients can enjoy a near-normal quality of life at home. Many of these patients can shop, travel, visit family and participate in other normal activities.”

In January 2009, SynCardia will apply to the FDA to conduct an IDE clinical study of the Companion Driver System in the U.S. and apply for CE approval in Europe. The Companion Driver is designed for use in both the hospital and at home. SynCardia projects a 400% increase in the number of patients benefiting from the CardioWest artificial heart in the 24 months following regulatory approvals.

Originally designed as a permanent replacement heart, the CardioWest artificial heart is currently approved as a bridge to human heart transplant for patients dying from end stage biventricular failure.

The CardioWest artificial heart is the first and only FDA, Health Canada and CE Mark approved temporary Total Artificial Heart in the world. There have been more than 750 implants of the CardioWest artificial heart, accounting for more than 140 patient years of life on the device.