FDA Approves Trimedyne’s Laser Needle
Trimedyne Inc. on Wednesday announced that it has received clearance from the federal Food and Drug Administration to market a laser needle that could make it easier for doctors to reach cancerous tumors.
The Irvine manufacturer of surgical laser systems said that the FDA approved the marketing and sale of its Sidefire laser needle in 10 more surgical techniques, including general surgery, prostate surgery and dermatology.
Previously, the use of the needle had been approved only for orthopedic problems, such as lower back pain.
The needle “could enable doctors to reach tumors almost anywhere in the body and treat them while they are small and before they have spread,” said Trimedyne Chairman Marvin P. Loeb in prepared remarks.
The new product offers “a less invasive, lower-cost alternative to surgery” while avoiding the adverse effects of chemotherapy and radiation, he said.
The new procedures that allow for the use of the Sidefire needle involve the use of a thermal, or hot, laser. The needle is attached to a catheter and is pushed through the skin toward the tumor. The hot laser beam then is used to vaporize the cancer cells in the tissue.
Other areas in which the Sidefire needle and hot laser could be used are pulmonary medicine, neurology, gynecology, urology, gastroenterology, plastic surgery and ear-nose-throat surgery.
The laser needle could also be used to eliminate polyps or other growths that cause pain or bleeding.
With FDA approval, Trimedyne now can market the Sidefire needle to physicians who work in the 10 areas to determine just how big a demand there is for the product.
“We’ll explore not all, but some of the major” medical procedures, said Richard Demmer, Trimedyne’s corporate secretary. “We believe this is a very significant advancement.”
Trimedyne has had FDA approval to use the Sidefire needle with a cold laser to treat spinal disks that cause back pain.
In that procedure, a fiber-optic cable is threaded inside a needle, which is inserted into the spine and positioned in a swollen disk while physicians watch through a fluoroscope. The cold laser then vaporizes a cavity at the center of the disk, reducing the disk to normal proportions.
A cold laser can be useful in surgery because it can cut tissue without burning nearby organs, which can occur with thermal lasers.
Trimedyne has also been marketing its lasers, with FDA approval, in a handful of other procedures, such as the treatment of stomach and intestinal maladies.
“Obviously, they have been getting a lot of things approved, which could add up to something significant for the company,” said Jeffrey Kilpatrick of Newport Securities in Costa Mesa. “The breakthroughs that are monstrously significant don’t happen that much.”
