The British Standards Institution (BSI) is beginning an Onsite FastTrack Review of the European CE Marking application of SynCardia‘s (Tucson, Arizona) Companion Driver System.
The new device, a power center for the company’s CardioWest temporary artificial heart, is designed to allow early patient ambulation, and a possible early discharging of patients who would otherwise have to stay hospitalized.
From SynCardia’s press release:
During the week of Jan. 19-23, the British Standards Institution (BSI) is performing an Onsite FastTrack Review of the European CE Marking application for the Companion Driver System. This system is intended to power the CardioWest™ temporary Total Artificial Heart (TAH-t) in the operating room, the ICU and for discharge. Although not guaranteed, the goal of the BSI program is to complete the CE Marking review process in 45 working days. SynCardia currently has the CE Marking for the CardioWest artificial heart, the “Big Blue” hospital driver and the European portable driver through BSI.
“The Onsite FastTrack Review is not for the faint of heart. It is designed for customers who have their ducks in a row and are ready to go to market in Europe,” said Dr. Andre Routh, the BSI Senior Product Expert working with SynCardia. “We are working onsite with SynCardia to advance effectively toward European regulatory approval of the Companion Driver System.”“SynCardia is taking advantage of a valuable opportunity by participating in the BSI FastTrack Program,” said Rodger Ford, CEO and president of SynCardia Systems, Inc., manufacturer of the CardioWest artificial heart. “Once we achieve regulatory approval in Europe and the U.S., we are projecting a 400% increase in the number of patients benefiting from the CardioWest artificial heart in the following 24 months.”
In Europe, CardioWest artificial heart patients can wait up to two years for a matching human heart. While demand is growing, the supply of donor hearts worldwide remains flat. In 2007, CardioWest implants accounted for 20 patient years of life on the artificial heart. In 2008, that number grew to 30, a 50% increase in patient years with only a 4% increase in the number of implants.
Discharge drivers allow stable CardioWest patients to enjoy a near-normal quality of life at home while they wait for a matching donor heart. Many of these patients can shop, travel, visit family and friends and live life like people with human hearts.
In Europe, CardioWest artificial heart patients can wait up to two years for a matching human heart. While demand is growing, the supply of donor hearts worldwide remains flat. In 2007, CardioWest implants accounted for 20 patient years of life on the artificial heart. In 2008, that number grew to 30, a 50% increase in patient years with only a 4% increase in the number of implants.Press release: SynCardia Fast Tracks CE Marking Submission for Companion Discharge Driver
CardioWest™ temporary Total Artificial Heart product page…
Flashback: The CardioWest TAH-t