Trimedyne Inc. said it has moved a step closer to replacing traditional heart-bypass operations with less costly and less traumatic laser surgery.
The Santa Ana laser manufacturer announced that it has received permission from the U.S. Food and Drug Administration to begin testing its plaque-zapping laser system as an alternative to coronary-bypass procedures.
Last year, the FDA gave Trimedyne permission to begin testing its system as a complement to bypass surgeries. Approximately 30 patients at several medical centers across the nation received laser treatments from the company's Optiscope fiber-optic laser catheter during their heart-bypass operations.
However, the latest move by the FDA brings Trimedyne closer to reaching its goal of offering laser procedures in place of full heart-bypass surgeries. Under the study approved Tuesday, approximately 30 patients at three medical centers will receive laser treatments rather than undergoing a full heart bypass for the type of heart disease caused by buildup of plaque and fatty deposits in the arteries.