Electrophysiology device developer EP MedSystems of West Berlin, NJ, said it intends to file a request for premarket approval with the Food and Drug Administration for its Alert CS/RA catheter system.
The product replaces existing electrophysiology catheters, allowing routine diagnostic procedures and the capability to internally cardiovert atrial fibrillation to normal heart rhythm during the procedure, according to the company.
Pending FDA approval, the firm said it anticipates launching the product in the U.S. during the first quarter of 2006.
By AuntMinnie.com staff writers
May 31, 2005
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