FDA Decision Could Be Boon for Trimedyne

Trimedyne Inc. is hoping to revive its flagging laser sales after receiving federal government approval to market a laser product for use in a new surgical procedure for removing gallbladders.

“The reality is this breathes new life into laser sales for us,” said Pete Escallier, Trimedyne’s marketing director, about the Food and Drug Administration’s approval last Friday of the company’s laser procedure.

Trimedyne originally developed its so-called “hot-tip” laser for opening clogged arteries in the leg and heart. In 1987, the Trimedyne laser was the first laser of any kind to win FDA approval for use in leg surgery, spurring brisk sales for the Tustin biomedical firm.

But sales skidded almost to a halt after Trimedyne experienced delays in obtaining FDA approval for using the hot-tip laser for heart surgery.

Trimedyne’s hot-tip laser--also known as the Neodymium Yag laser--has also encountered emerging competition from an alternative, so-called “cold laser” technology.

While the hot-tip laser uses heat to evaporate fatty deposits in blood vessels, an alternative cold laser cuts through the plaque with short bursts of ultraviolet light and eliminates the heat that may damage an artery. The FDA has not yet approved cold lasers for opening clogged arteries.

Blaming marketplace “confusion” over the effectiveness of its hot laser, Trimedyne lost $1.9 million in the quarter ended March 31 as sales plunged 70%. For the first six months of fiscal 1990, the company lost $2.45 million, contrasted with earnings of $1.5 million a year earlier.

Escallier said physicians are showing increased interest in a new type of gallbladder surgery called laparoscopic cholecystectomy and that interest “is what is driving a lot of laser sales now.”

In this new procedure, he said, the gallbladder is severed by the laser, which cauterizes as it cuts, and is removed through a 1-inch incision in the abdomen rather than the 6- to 8-inch incision required with traditional gallbladder surgery.

He said the new technique typically allows patients to leave the hospital in one day and return to work in a week. That compares to five to seven days of hospitalization and three to five weeks of recuperation at home with the traditional procedure.

While the new gallbladder surgery can be done with alternative implements, Escallier said that some physicians prefer lasers because of their precision and ability to stop bleeding with heat.

Escallier said some hospitals already had been placing orders for Trimedyne’s hot-tip laser in anticipation of last week’s FDA approval.

He said lasers supplied by other manufacturers have also received FDA approval for use in gallbladder surgery, but that Trimedyne’s is the only one also approved for leg surgery. FDA officials were unavailable Thursday to confirm Trimedyne’s claim.

Escallier said Trimedyne has also obtained FDA approval to use its hot laser for about a dozen other non-vascular surgical procedures, including general surgery, gynecology and urology.

He said the new uses for the Trimedyne laser will give greater leverage to surgeons trying to persuade hospital administrators to purchase the $100,000 piece of equipment.

Trimedyne expects within 45 days to receive similar approval from the FDA to market a newer-model laser for gallbladder surgery, Escallier said. He said 150 of those models have been sold by Trimedyne.