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SOUTH SAN FRANCISCO, Calif-The US Food and Drug Administration (FDA) has approved Cathflo Activase (Alteplase) for the restoration of function to central venous access devices (CDADs) that have become occluded by a blood clot, or thrombus.
Cathflo Activase is a thrombolytic agent that works by targeting substances that cause blood to clot. The device dissolves the clot and restores function to the CVAD. This is the first thrombolytic agent approved by the FDA for this purpose.
CVADs, a broad term that includes many types of catheters, are used to withdraw blood or administer medications and nutritional fluids to critically ill patients. There are an estimated 5 million catheters used in US hospitals annually, with 25% of these estimated to become blocked.
Cathflo Activase works by activating plasminogen that dissolves fibrin-a substance that causes blood to clot. This process breaks down the thrombus and leaves the CVAD functioning properly.
FDA approval of the device is based on two Phase III clinical trials that tested safety and efficacy in the restoration of CVAD function during the process.
The device has been created by Genetch, Inc., based in South San Francisco, California.
For more information about the company, log onto www.gene.com