FDA Approves Sale of Trimedyne Lasers

Trimedyne Inc. said Monday it received regulatory clearance to market its Holmium laser and associated fiber-optic devices to treat lower back and leg pain from herniated or ruptured lumbar discs.

Irvine-based Trimedyne said it is the first company to receive clearance from the U.S. Food and Drug Administration to market a laser for use in foraminoplasty, which is the medical term for this procedure. Earlier, Trimedyne’s treatment received approval to decompress herniated lumbar discs whose walls have not ruptured. Lumbar refers to the lower back region.

Foraminoplasty uses the laser energy to vaporize a small amount of bone that allows surgeons to see the nerves in the spinal column and repair ruptured or herniated discs.

An estimated 20 million people in the United States suffer from lower back pain, and 80% to 90% of adults experience lower back pain at some time in their lives, the company said.

The most commonly used procedure to treat a herniated or ruptured disc is from an open laminectomy, which leaves the patient with reduced mobility and a “significant recovery period,” Trimedyne said.

The company’s stock closed at $1.94, up 63 cents a share, in Nasdaq trading.