Gambro BCT, Inc. and Fenwal, Inc. today announced their decision to suspend the PASSPORT (Post Approval Surveillance Study of Platelet Outcomes, Release Tested) Study for 7-day platelet storage. This action is being taken as a precautionary measure in the interest of patient safety while Gambro BCT and Fenwal collaborate with the U.S. Food and Drug Administration to explore modifications to the PASSPORT study

LAKEWOOD, Co., and LAKE ZURICH, Ill., — Gambro BCT, Inc. and Fenwal, Inc. today announced their decision to suspend the PASSPORT (Post Approval Surveillance Study of Platelet Outcomes, Release Tested) Study for 7-day platelet storage. This action is being taken as a precautionary measure in the interest of patient safety while Gambro BCT and Fenwal collaborate with the U.S. Food and Drug Administration to explore modifications to the PASSPORT study.

The companies are voluntarily suspending the study based on an interim data analysis of the PASSPORT study, along with a review of other published studies, which estimate that up to 50% of bacterially contaminated platelets may escape detection by culture at 24 hours¹. Undetected contaminated units that are placed into inventory for transfusion may pose a risk that increases with the length of time the platelets are stored before they are transfused. Although the magnitude of the incremental risk is unknown at this time, it may be reduced by limiting shelf life to five days until risk mitigation measures are determined for longer platelet storage.

Gambro BCT and Fenwal’s foremost concern is patient safety. The companies will continue to work collaboratively to explore modifications to the PASSPORT study that will ensure a safe, efficacious 7-day platelet product.

Media Contact:
Gambro BCT
Becky Lippincott: (303) 231-4743
Vic Turpaud: (303) 542-5059

Fenwal
Tanya Tyska: (847) 550-2732

Gambro BCT improves lives through innovation, quality and services delivered by our people, products and processes in blood component technology. Gambro BCT is a world leader in automated blood collections, therapeutic apheresis, and cell therapy, as well as an innovative leader within automated blood component separation and purification technologies. The Company has approximately 2,000 employees and more than USD $390 million in annual revenues.

Fenwal is a leading, global healthcare company focused on the development, manufacture and marketing of products and services for the transfusion medicine industry. The company provides a comprehensive portfolio of products and services for manual and automated blood collection, processing and storage. For more information, please visit http://www.fenwalinc.com/.

¹ Foley et al. Transfusion 2007; 47(3S); 37A and Eder et al. Transfusion 2007; 47: 1134-42.

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