Micronet announces FDA approval of Axxess Spinal Cord Stimulation Lead

Micronet Medical, Inc. (MMI) recently announced that it has received FDA approval for its Axxess Spinal Cord Stimulation Lead. At .83 mm in diameter, the Axxess lead is the smallest diameter neurostimulation lead in the market. It is designed to be used as part of a spinal cord stimulation (SCS) system and is used to aid in the management of chronic, intractable pain of the trunk and limbs.

About 22 million people suffer from back and neck pain in which spinal cord stimulation may be helpful, according to a study by U.S. Bancorp Piper Jaffrey. There are roughly 200,000 new cases each year in the United States alone. The market for treatment of pain via spinal stimulation was $200 million in 1999, and is expected to grow to over $400 million by 2003, a growth rate of over 25% per year.

Tom Brust, President and CEO of Micronet Medical, said, "We are very pleased with the FDA's action. Approval of the Axxess lead is a significant milestone for Micronet Medical as we evolve from a contract service provider to a company with our own established product line. The Axxess lead is the first of a family of leads for use with neurostimulation systems."

Preliminary feedback from physicians involved in the clinical evaluation of the Axxess lead has been very promising. They give the lead high marks for both steerability and torqueability, two handling characteristics that facilitate precise placement in the spinal stimulation site. Typical of their response is the remark from one physician that the Axxess lead is "The best lead I've ever driven."

Micronet Medical, Inc. (MMI) is a privately held company based in St. Paul, Minnesota. Micronet Medical advances the technology and performance of neurostimulation leads through miniaturization, innovation, and creative application of customer input. MMI also provides full service contract manufacturing and sterilization services for all classes of medical devices.

Source: Micronet Medical, Inc.