Trimedyne Inc. said it has received Food and Drug Administration permission to begin human testing of its Coronary Laserprobe--a non-surgical substitute for heart-bypass operations.
The Santa Ana laser manufacturer will spend the next 12 to 18 months testing the laser catheter to treat atherosclerosis of the heart, according to Michael Henson, president and chief executive.
If the tests are successful, the Coronary Laserprobe could be used to treat some or all of the 200,000 bypass surgery patients in the country each year, he said.
Henson said that the company, which has funneled more than $5 million into the Coronary Laserprobe over the past four years, should begin seeing test results for its patients in about six months.
Last year, the FDA gave Trimedyne permission to test its laserprobe-PLR on humans to treat atherosclerosis of the legs. Although the testing won't be complete for four months, Henson said that preliminary results have been positive.
Atherosclerosis is caused by fatty deposits and plaque buildup in the heart or blood vessels. The laser dissolves the material without surgery.