Canada Allows Trimedyne to Market Laser Catheter

Trimedyne said the Canadian government has given it permission to market its Laserprobe-PLR catheter in that country. The action follows Trimedyne’s receipt of marketing approvals from the governments of England, France, Germany, Holland, Norway, Spain, Sweden and Switzerland.

The Santa Ana-based medical laser company’s Laserprobe-PLR catheter uses a laser energy delivery system to vaporize fatty deposits and plaque which block arteries in the legs and cause atherosclerosis. In the past, major bypass surgery or leg amputation have been the only treatment alternatives for patients with severe blockages.

Trimedyne estimates that more than 80,000 people in Canada and Europe require treatment for such conditions each year.

The company obtained Food and Drug Administration approval last year for domestic clinical trials of of its Laserprobe-PLR catheter for non-surgical treatment of atherosclerosis in the leg. In June, Trimedyne received FDA approval for clinical trials of its Coronary Laserprobe in non-surgical treatment of atherosclerosis in the heart.