Trimedyne Surgical Laser OKd for Tests on Patients
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.
The estimated 200,000 bypass surgeries now performed each year in the United States have long stood as potential opportunities for laser system developers. Experts have estimated that a laser treatment to remove the plaque that builds up in a heart disease patient’s arteries can cut the cost and hospitalization time by 50%.
Trimedyne’s device is a multichannel catheter that is threaded through a patient’s artery. One fiber optic in the catheter carries a tiny microscope-like device that allows a physician to see the inside of blood vessels to locate the disease-causing fatty deposits. Another channel carries the laser energy.
Trimedyne president Michael Henson said the company hopes to complete its newest round of tests by next April. He said that if the test process moves smoothly, the company would ask the FDA early in 1987 for approval to sell the laser system to physicians.