BUSINESS STANDARDS
is the quarterly magazine of BSI Group, highlighting the vital role that standards play in today's business environment. Regular features include interviews with leading business figures, as well as news on the latest developments in management systems and standards.
Companion Driver System takes the fast track
20 Feb 2009
Topics: Healthcare, CE mark, USA, Americas
In January 2009, BSI performed an Onsite FastTrack Review of the European CE Marking application for the Companion Driver System, with a view to completing the CE Marking review process in 45 working days.
The Companion Driver System powers the CardioWest™ temporary Total Artificial Heart (TAH-t) and can be used in the operating room, the ICU and when a patient is discharged. Both medical devices were designed and are manufactured by SynCardia Systems, Inc in the US.
SynCardia Systems, Inc. has already earned CE Marking for the CardioWest artificial heart, the "Big Blue" hospital driver and the European portable driver, through BSI.
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 per cent increase in patient years with only a four per cent increase in the number of implants.
The Companion Driver System is designed to allow stable CardioWest artificial heart patients to recover at home. Discharge drivers allow stable CardioWest patients to enjoy a near-normal quality of life at home while they wait for a matching donor heart.
"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," says Dr Andre Routh, 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. "Once we achieve regulatory approval in Europe and the US, we are projecting a 400 per cent increase in the number of patients benefiting from the CardioWest artificial heart in the following 24 months."
For more information, visit http://www.bsiamerica.com/healthcare
Image courtesy of syncardia.com
Business Standards © 2009. Editorial produced by Caspian Publishing in association with the British Standards Institution. Editorial opinions expressed on are not necessarily those of BSI Group or Caspian Publishing. Neither Caspian Publishing nor BSI Group accept responsibility for advertising or editorial content, nor for that appearing on linked third-party websites. Reproduction in whole or in part is forbidden without written permission from BSI Group or Caspian Publishing.
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