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Biotech / Medical : Medtronic (MDT) -- Ignore unavailable to you. Want to Upgrade?

To: Tunica Albuginea who wrote (484)	5/1/2000 12:26:00 PM
From: Tunica Albuginea	Read Replies (1) \| Respond to of 687

Medtronic Sofamor Danek's Next-Generation Spinal Fusion 'Cage' Approved For Use by U.S. Spine Surgeons to Treat Low Back Pain ( Note: There is a significant number of patients in the US suffering from debilitating back pain that could benefit from th ecage ). todaysheadlinenews.com MINNEAPOLIS, Monday May 1, 9:02 am Eastern Time/PRNewswire/ -- Medtronic, Inc. (NYSE: MDT - news), today announced clearance of the Sofamor Danek INTER FIX(TM) RP (Reduced Profile) Threaded Spinal Fusion Device by the U.S. Food and Drug Administration (FDA). The innovative threaded ``cage'' implant is designed for use by spine surgeons to treat patients with debilitating back pain caused by degenerative disc disease. More than five million Americans suffer from severe chronic pain of the lower back. A common cause of the debilitating condition is degenerative disc disease, which reduces the height of the vertebral structures that comprise the spine. Spinal fusion helps restore height to discs that have degenerated and promotes renewed structural stability of the spine. The new device is designed to be used in conjunction with its predecessor -- the INTER FIX Threaded Spinal Fusion Device, which was released in the United States in May 1999. Both devices are cylindrical in shape, but the new device has a ``C'' cut out of one side, or a ``Reduced Profile,'' that enables the two devices to be interlocked. Because spinal fusion typically requires the placement of two cages side by side, the design of the new device saves space while providing the necessary vertebral support. Each year, U.S. spine surgeons perform more than 100,000 lumbar spinal fusions. The addition of the new device to the INTER FIX(TM) family adds a significant surgical option to those surgeons already enjoying the demonstrated effectiveness of the original INTER FIX Threaded Spinal Fusion Device. The new device will be available to U.S. spine surgeons immediately. ``The U.S. market for spinal cages is currently estimated at more than $200 million,'' said Ron Pickard, President of Medtronic Spinal and Neurologic Technologies. ``We're confident that the INTER FIX family of Threaded Spinal Fusion Devices will continue to grow as the favored choice of U.S. spinal surgeons in this significant market segment.'' Michael DeMane, President of Sofamor Danek Spinal Systems, said that the company considers the new spinal cage a ``third generation'' threaded fusion device. ``This unique design allows the surgeon to place bilateral cages in a reduced lateral profile exposure without sacrificing the important 'bridges' of support for bony structure.'' When implanting the INTER FIX RP device, the surgeon first packs the hollow, threaded cage with small pieces of bone taken from another part of the patient's body. The packed cage is then implanted between adjacent vertebral structures after spacing and alignment have been established. When natural bone grows through holes in the cage, it fuses with natural bone inside it, and fusion and stability are achieved. Key features of the INTER FIX RP cage include: Reduced Profile design requires less dissection, retraction and exposure. Bilateral placement of cages is now made possible when anatomical constraints might otherwise prevent it. Open design facilitates packing of a large volume of autogenous bone. Self-tapping design allows for the elimination of a surgical step commonly used for other devices. INTER FIX RP Threaded Spinal Fusion Devices are available to surgeons in sizes ranging from 12 mm. to 24 mm. in diameter and from 20 mm. to 29 mm. in length. Medtronic, Inc., headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease. Its Internet address is medtronic.com Any statements made about the company's anticipated financial results and regulatory approvals are forward-looking statements subject to risks and uncertainties such as those described in the company's Annual Report and Form 10-K for the year ended April 30, 1999. Actual results may differ materially from anticipated results. SOURCE: Medtronic, Inc.