Recent regulatory news has focused on the approval of a left ventricular-assist system (LVAS) in Canada and a cyclosporine dispenser in the United States.
Thermo Cardiosystems of Woburn, Mass., announced on August 26 that the Medical Devices Bureau of Health Canada has given permission for the company to sell both the pneumatic and electric versions of its HeartMate LVAS throughout Canada. "For the first time, Canadians diagnosed with endstage heart failure will be able to leave the hospital and return to their everyday routines and productive lives while recovering. We look forward to working initially with the 12 heart transplant centers in Canada," said Victor L. Poirier, president and chief executive officer of Thermo Cardiosystems.
SangStat of Menlo Park, Calif., has received Food and Drug Administration approval to market its CycloTech oral cyclosporine dispenser. The oral cyclosporine that the device was designed to dispense is in final stages of FDA review, and CycloTech fits SangStat's cyclosporine only. The device displays dosing information that can be downloaded by physicians.
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