HEALTH CARE : FDA Delay

It wasn’t much of a Christmas present, but Trimedyne Inc. is taking the latest news from the U.S. Food and Drug Administration in stride.

The maker of lasers and catheters for minimally invasive urological, orthopedic and cardiovascular surgery, was told last week that it will have to wait another three months before it can present its newest catheter to an FDA panel of doctors. The panel makes recommendations to FDA regulators for marketing approval of medical devices.

Trimedyne spokeswoman Kathy Price said the panel meeting--originally scheduled for next month--was postponed until mid-March. That means that approval of the catheter, which the company first submitted to the FDA last summer and calls a Urolase, will not be until spring, if at all.

“We do not interpret this as a negative thing,” Price said. “We’ll just keep our fingers crossed.”

Trimedyne, under a joint venture with Georgia-based C.R. Bard, a medical supplies distributor, has been trying to get the FDA to approve the catheter, which is connected to a laser and would treat enlarged prostate glands, a debilitating and sometimes fatal condition found in elderly men.

Trimedyne would be the only company worldwide to manufacture such a laser device, Price said. C.R. Bard would be the distributor.

Although the FDA notice was considered bad news, Price said the federal regulatory agency promised to expedite the approval process for Trimedyne, once it has heard recommendations from the panel.