FDA Grants Fenwal New 510(k) Clearance
LAKE ZURICH, Ill., Aug. 12 /PRNewswire/ -- Fenwal Inc., a global medical technology company focused on improving blood collection, separation, safety and availability, announced today that the U.S. Food and Drug Administration has granted Fenwal a new 510(k) clearance for its Amicus® blood cell separator.
The new clearance involves the use of the Amicus® separator with InterSol® platelet additive solution, which Fenwal introduced earlier this year. InterSol is an electrolyte-based fluid that replaces 65 percent of the human plasma previously needed as a storage solution for donated platelets. Blood centers can collect the plasma replaced by InterSol and provide it to hospitals where it is used to treat patients.
While practices vary at blood centers, healthy donors may donate platelets as often as once a week, but no more than 24 times in a 12-month period. In granting the new 510(k) clearance, the FDA has approved an addition to Fenwal labeling that defines specific conditions under which the volume of plasma replaced by InterSol® solution may be collected without increasing the donor deferral period.
"This helps blood centers and hospitals realize the clinical and financial benefits of platelet collection using additive solution," said William H. Cork, Fenwal chief technology officer. "At Fenwal, we are focused on delivering a series of innovations that continuously improve how blood is collected, separated, treated, stored and transfused for patients around the world."
In December 2009, the FDA called the approval of Fenwal's InterSol® solution "a significant step in the development and marketing of novel processes for the storage of platelets."(1) Today, InterSol is the only platelet additive solution available in the United States, where more than 2 million platelet transfusions take place each year.
Platelets are given to patients to help prevent or stop bleeding. They are needed by trauma victims and cancer patients undergoing chemotherapy.
Fenwal, Inc. is a global medical technology company focused on improving blood collection, filtration, separation, storage and transfusion to ensure the availability, safety and effectiveness of blood components. Fenwal is unique in the depth of its experience and commitment to transfusion medicine. The company offers the broadest range of products for the automated and manual collection of blood and blood components. Fenwal became an independent company in 2007, but its roots go back to 1949 with the founding of Fenwal Laboratories. Fenwal developed the first flexible, single-use container for blood collection, eliminating complications associated with glass containers and allowing blood to be separated into therapeutic components. Today, the company's products and advanced collection and separation technologies are used to help treat patients on six continents. Fenwal, Inc. is based in Lake Zurich, Illinois. For more information, please visit www.fenwalinc.com.
(1) FDA, 2009. "FDA Approves First Additive Solution for Platelet Storage Up to 5 Days," United States Food and Drug Administration Press Release. [accessed: March 3, 2010] http://www.prnewswire.com/news-releases/fda-approves-first-additive-solution-for-platelet-storage-up-to-5-days-78971167.html.
SOURCE Fenwal, Inc.