Pain management specialists in the U.S. have a new diagnostic tool to put in their belt, which may help them determine the source of a patient's back pain without provoking pain in an attempt to locate the suspected disc.

Medtronic (Minneapolis) has launched its Discyphor Direct Catheter System, a second-generation system designed to give doctors more information to diagnose discogenic low back pain. Unlike typical means of diagnosis, the company says the Discyphor Direct, used with its Functional Anaesthetic Discography (FAD) procedure, diagnoses the patient's pain by anesthetizing each suspect disc individually.

According to Medtronic, more than 100,000 patients annually undergo spinal surgery for discogenic low back pain in the U.S., but patient satisfaction from such surgeries is mixed.

"With the Discyphor Direct Catheter System, we are empowering physicians to independently assess discs to determine the source of a patient's back pain while delivering many enhancements over our first-generation product," said Robert White, president of Kyphon (Sunnyvale, California) and Interspinous Process Decompression Devices for the Spinal and Biologics business at Medtronic, which sells the Discyphor product line. "Both patients and physicians will benefit from this new system because of its improved ease of use and a needle that is designed with an atraumatic or blunt tip."

Denise Franklin, a spokeswoman for Medtronic's Kyphon business, told Medical Device Daily that with the typical means of diagnosing discogenic back pain the physician tries to reproduce the patient's back pain in an attempt to locate the suspected disc. One problem with that method, she said, is that the results are very subjective given that every patient has a different tolerance to pain. During a FAD procedure with the Discyphor Direct system, however, a "very small" balloon catheter is anchored into the discs suspected of causing pain, which allows injection of anesthetic while the patient is performing typical pain-eliciting activities, such as bending over or picking something up. If the patient shows improved functional response to the anesthetic injection, the doctor is able to make a more informed diagnosis of the source of the pain, the company said. The procedure also facilitates diagnosis of discogenic pain at multiple levels, one at a time, through the use of multiple catheters. Franklin said that the actual evaluation of the patient is happening in the recovery room as opposed to an operating room.

"This is very similar to what we do with other joints today, even the spine. It is the same technology we use in other joints, [now] we are bringing it to the disc joint," Franklin said.

The goal of the technology, Franklin said, is to improve patient outcomes. She said the company acquired the technology a few years ago from a spine surgeon "and his main goal was to improve patient outcomes."

The core balloon catheter technology was cleared for marketing in the U.S. in April 2005. Medtronic says it continues to conduct clinical studies to scientifically show the diagnostic utility of this procedure. According to the company, the FAD procedure was introduced two years ago and has been used on more than 3,000 patients.

While pain management specialists often perform the procedure, Medtronic says that spine surgeons benefit from the diagnostic information to help determine the optimal treatment for their patients. That's why the company plans to introduce the Discyphor system to the spine surgeon community at the annual meeting of the North American Spine Society (Burr Ridge, Illinois) next month in Toronto.

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