FDA approves use of genetically engineered protein to treat lower back pain, biologic protein creates bone growth where needed and eliminates second surgery required in traditional spine fusion procedures

MEMPHIS, Tenn., July 2, 2002--With the exception of colds and flu, backaches send more people to the doctor than any other ailment. The problem is so serious that in 2002, more than 190,000 Americans are expected to undergo lumbar spinal fusion surgeries to ease their debilitating back pain and get them back on their feet. For these patients with the most crippling pain, good news arrived today when the U.S. Food and Drug Administration (FDA) announced the approval of Medtronic Sofamor Danek's INFUSEŽ Bone Graft/LT-CAGEŽ Lumbar Tapered Fusion Device.

INFUSE Bone Graft contains recombinant human bone morphogenetic protein (rhBMP-2), the genetically engineered version of a naturally occurring protein that is capable of initiating bone growth, or bone regeneration, in specific, targeted areas in the spine. Approved for use with the LT-CAGE Lumbar Tapered Fusion Device, INFUSE Bone Graft is indicated to treat certain types of spinal degenerative disc disease, a common cause of low back pain. Using INFUSE Bone Graft with the LT-CAGE Device in spine surgery reduces the pain and complications associated with treating degenerative disc disease by eliminating the second surgery required to harvest bone from a patient's hip, as is done in traditional spinal fusion procedures.

Degenerative disc disease is a disorder of the spine that can be extremely painful and debilitating in patients who generally lead active lives. The disease occurs when discs in the spine are damaged. Pain emanates from the damaged discs themselves or is caused by the discs or bone impinging on nearby nerve roots or the spinal cord. By the age of 50, approximately 85 percent of the population will show evidence of disc degeneration.

Spinal fusion surgery is often the only effective method to treat degenerative disc disease. Spinal fusions essentially "weld" two or more vertebrae together to eliminate the pain caused by a damaged disc in the spine. To fuse the vertebrae together, surgeons traditionally insert pieces of the patient's own bone between the vertebrae to prompt the body to grow new bone. But implanting the bone chips actually requires two surgeries -- one to chip off small pieces of bone from around the patient's hip (autograft) and another to insert them in the spine. Studies have shown that the bone harvesting procedure can be more painful than the fusion itself, and nearly a third of patients experience some hip pain two years following surgery.

INFUSE Bone Graft eliminates the painful harvesting surgery because it contains rhBMP-2, which induces the body to grow its own bone where it is needed. Discovered and developed by Wyeth (NYSE: WYE), rhBMP-2 is manufactured in its Andover, Mass., biopharmaceutical facility.

To use INFUSE Bone Graft, surgeons reconstitute the rhBMP-2 powder with supplied sterile water and then apply it to collagen sponges. The sponges are inserted inside each of two LT-CAGEŽ Lumbar Tapered Fusion Devices, which are then implanted between the vertebrae. The thimble-like cages stabilize the spine while it is fusing and also maintain the proper height between the vertebrae. The tapered design of the cage is intended to help restore the natural curvature (lordosis) between vertebrae in the spine, as compared to traditional cylindrical cages.

"The FDA approval of INFUSE Bone Graft represents a new approach to the treatment of low back pain and is a major advance in traditional spine surgery," said Kenneth Burkus, M.D., an orthopedic surgeon at the Hughston Clinic in Columbus, Ga., who participated in numerous clinical trials and has the most clinical experience in the world with the product. "The combination of a biological product with a medical device, intended to effectively fuse vertebrae in the spine, is a significant step for orthopedic and neurosurgical procedures for both physicians and patients. Spine surgeries with INFUSE Bone Graft and the LT-CAGE Device will be quicker, less expensive and, more importantly, less painful for the patient."

Compelling Data Leads to Approval
Marketing clearance for the INFUSE Bone Graft/LT-CAGE Device is based on compelling data from a large-scale, multi-center, prospective, randomized, two-year study involving 279 degenerative disc disease patients implanted with the LT-CAGE Lumbar Tapered Fusion Device. The study assessed the safety, efficacy and therapeutic benefits of INFUSE Bone Graft as compared to traditional autograft procedures. Approximately half of the patients in the study received autograft bone, and the other half received INFUSE Bone Graft.

The data showed that the study met all of its primary endpoints. Although statistically equivalent, study results indicated that patients who underwent spine surgery using INFUSE Bone Graft showed a trend toward having higher fusion rates as compared to autograft patients at 24 months (94.5 percent fused versus 88.7 percent). Patients implanted with INFUSE Bone Graft also spent less time in the operating room and lost less blood during surgery than the autograft patients. Although both INFUSE Bone Graft and autograft patients received similar levels of low back pain relief, the INFUSE Bone Graft patients did not experience hip donor site pain, because they did not require the second procedure to harvest bone graft from the hip.

"Bone morphogenetic proteins have been studied for use in bone regeneration for more than 30 years," said Scott Boden, M.D., an orthopedic surgeon from The Emory Spine Center at the Emory University School of Medicine, who has published extensively on rhBMP-2. "After following the progress of the INFUSE product, and seeing its efficacy in numerous clinical trials over the years, it's exciting to see the product FDA-approved and available to surgeons. This product has the potential to redefine the way spine surgery is performed."

The elimination of the graft harvesting procedure empowers surgeons with a more patient-friendly therapy, and physicians are no longer forced to cause pain in one part of the body to cure it in another. Other advantages include:

• INFUSE Bone Graft patients should spend less time in the operating room.
  
• Surgeons should require fewer instruments for INFUSE Bone Graft procedures.
  
• Patients should experience fewer complications from the graft harvest site, which may result in fewer follow-up hospital visits.

One Patient's Experience (Results May Vary)
When Teresa Hoffman, 38, first began experiencing a radiating pain in her lower back and down her legs, she quickly dismissed it. But when the pain wouldn't go away, she decided to visit a chiropractor. The treatments seemed to work for a while but soon the pain was back, and worse than before. In fact, the pain had become so severe it was interfering with her daily activities and her full-time job as a financial assistant. "I felt disconnected at the waist," said the mother of three teens. "I couldn't stand for more than five minutes -- the pain felt like a knife in my tailbone." Taking her children to amusement parks or even watching them play baseball and football on their school teams became impossible because she could no longer stand or even sit for extended periods.

Eventually Teresa was referred to an orthopedic surgeon, who diagnosed her with a ruptured disc due to degenerative disc disease. Teresa had already suspected the cause of her excruciating pain because her mother and two sisters suffered with degenerative disc disease. She was also quite familiar with the standard therapies, including traditional spinal fusion surgery, as her older sister had undergone the surgery about a year earlier. "I was scared," said Teresa. "I was helping my older sister after the operation and her recovery was horrible. In fact, two years later, she still suffers with hip pain from the bone harvest."

Anxious to avoid new pain to treat her existing pain, Teresa learned about the clinical trial of INFUSE Bone Graft and decided to try the then investigational treatment. "It was amazing," said Teresa, who was able to get out of bed and walk around her hospital room shortly after the procedure. "It was a 1,000-percent improvement."

Now she's back to her busy life, working full-time again and raising her three teenagers with her husband. She's even swimming and playing racquetball, things she couldn't do before. And if Teresa needed further proof that she made the right decision about her surgery, she need only look at her younger sister, who recently underwent the traditional autograft procedure. "INFUSE Bone Graft was not approved at the time," Teresa says. "So my younger sister had to undergo the surgery on her hip and not surprisingly, her hip is now causing her excruciating pain. Needless to say, I feel very fortunate to have received the INFUSE Bone Graft."

For more information about INFUSE Bone Graft/LT-CAGE Lumbar Tapered Fusion Device, please visit www.back.com/graft.

Medtronic, Inc., headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease. Medtronic Sofamor Danek, headquartered in Memphis, develops and manufactures products that treat a variety of disorders of the cranium and spine, including traumatically induced conditions, degenerative conditions, deformities and tumors. More information can be found at: www.medtronicsofamordanek.com/patient-spinal-infuse.html.

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 Medtronic's Annual Report on Form 10-K for the year ended April 27, 2001. Actual results may differ materially from anticipated results.

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