Trimedyne Inc., a Santa Ana manufacturer of medical devices, said Tuesday that it has received permission from the U.S. Food and Drug Administration for final testing of its Laserprobe-PLR catheter, a non-surgical device for treating cardiovascular disease caused by fatty deposits and plaque in blood vessels.
The device, inserted through a small hole in the leg and threaded to the location of the disease, uses a laser to vaporize the diseased material. The company's tests indicate that the procedure is 97% successful, and the tests have saved 20% of the patients from leg amputations or major bypass surgery, said Michael R. Henson, president and chief executive officer of Trimedyne.
The device, used alone or with traditional non-surgical therapies, may allow individuals who now can only be treated through surgery to be treated non-surgically, with less trauma and less expensive therapy, Henson said. Trimedyne said that more than $4 billion is spent on 200,000 bypass procedures each year.
Last December, the company said it had raised $2.6 million to finance the development of Laserprobe-PLR devices for heart applications. Last month, Trimedyne said it had begun developing and testing the devices in a number of leading heart centers, including the Humana Heart Institute.
If the human studies are successful, Trimedyne's laser products can be used as an alternative to bypass surgery and balloon angioplasty, Henson said.