Healthcare Industry News:  Balloon catheter 

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 News Release - September 17, 2008

Medtronic Launches Discyphor Direct(TM) Catheter System

Second-Generation Product for Diagnosis of Discogenic Low Back Pain

MINNEAPOLIS--(HSMN NewsFeed)--Medtronic, Inc. (NYSE: MDT ), today announced the U.S. launch of the Discyphor Direct™ Catheter System, the second-generation catheter system used by physicians to obtain additional information to diagnose discogenic low back pain.

The Discyphor Direct Catheter System provides additional information to help identify which disc is causing a patient’s pain. More than 100,000 patients annually undergo spinal surgery for discogenic low back pain in the United States1, 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 and Interspinous Process Decompression Devices for the Spinal and Biologics at Medtronic, which markets 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.”

With the Discyphor Direct Catheter System, physicians use Medtronic’s innovative Functional Anaesthetic Discography™ (F.A.D. ™) Procedure that identifies a patient’s discogenic pain by anesthetizing each suspect disc individually. This procedure differs from typical means of diagnosis such as imaging studies or provocative discography, which generates pain in an attempt to locate the suspected disc. The F.A.D. Procedure was introduced two years ago and has been used on more than 3,000 patients.

During the F.A.D. Procedure, a proprietary Balloon catheter is anchored into discs suspected of causing pain, which allows injection of anesthetic while the patient is performing typical pain-eliciting activities. If the patient shows improved functional response to the anaesthetic injection, this allows physicians to make a more informed diagnosis of the source(s) of a patient’s low back pain and may help them choose the optimal treatment option. The procedure also facilitates diagnosis of discogenic pain at multiple levels, one at a time, through use of multiple catheters.

While the procedure is often performed by pain management specialists, spine surgeons benefit from the diagnostic information to help determine the optimal treatment for their patients. Therefore, Medtronic will introduce the Discyphor Direct Catheter System to the spine surgeon community at the annual meeting of the North American Spine Society (NASS) in Toronto, Canada in October. A technical forum, during which the Discyphor Direct Catheter System will be discussed, will take place from 6:30-8:30 p.m. (Eastern) on October 15 at NASS. Spine surgeons interested in more information should contact

The core Balloon catheter technology was cleared for marketing in the United States in April 2005. Medtronic continues to conduct clinical studies to scientifically show the diagnostic utility of this procedure.

More information about the Discyphor Direct Catheter System and the Functional Anaesthetic Discography Procedure can be found at

About the Spinal and Biologics Business at Medtronic

The Spinal and Biologics business is based in Memphis, Tenn., and operates its balloon kyphoplasty, X-STOP® IPD® and diagnostics business in Sunnyvale, Calif. It is the global leader in today’s spine market and is committed to advancing the treatment of spinal conditions. The Spinal and Biologics business works with world-renowned surgeons, researchers and innovative partners to offer state-of-the-art products and technologies for neurological, orthopaedic, dental and spinal conditions. Medtronic is committed to developing affordable, minimally-invasive procedures that provide lifestyle-friendly surgical therapies. More information about the company and its treatment therapies can be found at and its patient-education Web sites,,, and


Medtronic, Inc. (, headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health and extending life for millions of people around the world.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s Annual Report on Form 10-K for the year ended April 25, 2008. Actual results may differ materially from anticipated results.

KYPHON® Balloon Kyphoplasty and KYPHON® HV-R TM Bone Cement incorporate technology developed by Gary K. Michelson, M.D.

1 PearlDiver spine patient data report, © 2007, RRY Publications LLC

Source: Medtronic

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