Medtronic Neurosurgery Receives FDA Clearance for New Medical Device to Treat Hydrocephalus.

Business Editors & Health/Medical Writers

GOLETA, Calif.--(BW HealthWire)--Feb. 28, 2002

Winner of national design award, Strata(TM) valve enables

clinician to adjust pressure-level settings noninvasively

and verify adjustment without X-ray

Medtronic Neurosurgery, part of Medtronic, Inc. (NYSE:MDT), received FDA clearance this month to begin U.S. sales of the Strata(TM) valve, a new medical device used in the treatment of hydrocephalus, an abnormal accumulation of cerebrospinal fluid in the ventricles of the brain.

According to the National Hydrocephalus Association, hydrocephalus affects 15 in every 10,000 newborns and one in every 10,000 adults. Untreated, it can result in nervous system damage or death. Hydrocephalus can be acquired or congenital, resulting from a birth defect such as spina bifida. Acquired hydrocephalus develops after birth from some other factor, such as head trauma, a brain tumor or meningitis. Each year, about 160,000 people worldwide receive a hydrocephalic shunt.

The Strata valve, a grand prize winner of Design News magazine's 2001 "Excellence in Design Award," marks Medtronic Neurosurgery's latest innovation in hydrocephalic shunting, a technique for draining excess cerebrospinal fluid from the brain. It enables the clinician to adjust the device's five pressure settings noninvasively and without X-ray verification as the patient's condition changes. With a profile that makes it comfortable and discrete for patients, the Strata valve also features a clinically proven system for siphon control that protects against excess drainage of cerebrospinal fluid, a complication that can compromise the fluid dynamics of the central nervous system and lead to tissue tears or bleeding in the brain.

These features potentially reduce the frequency of valve replacements, which require additional surgery, and limit exposure to radiation, which in large doses raise health concerns among both patients and clinicians.

Spearheaded by Dr. John Kestle, associate professor of neurosurgery at Primary Children's Hospital (part of the University of Utah Hospital System) in Salt Lake City, the clinical study of the Strata valve involved 20 U.S. medical centers and 300 patients, all children 18 years of age or younger. The study showed shunt survival over 12 months with the Strata valve to be equal to or better than the alternative, which is a fixed-pressure valve.

"Our legacy in producing state-of-the-art solutions for the treatment of hydrocephalus afforded us the opportunity to collaborate with some of the country's leading pediatric neurosurgeons on this study of the Strata valve," said Austin Noll, vice president and general manager of Medtronic Neurosurgery. "We look forward to working with these and other physicians in the future to pioneer additional innovations in CSF management technology and cranial neurosurgery that improve patient care, the charter of our business."

Fully implantable under the patient's skin, a hydrocephalic shunt consists of three basic components: a proximal catheter, which goes into the brain cavity containing cerebrospinal fluid; a pressure valve, which regulates the rate at which the cerebrospinal fluid drains; and a distal catheter, which takes the excess fluid to the peritoneal cavity in the gut, where it becomes reabsorbed by the body. The valve connects the two catheters.

The Strata valve became available to the U.S. healthcare market Feb. 11, 2002, when the FDA cleared Medtronic Neurosurgery's premarket notification 510(k). Introduced in Europe in February 2000 following receipt of the CE Mark and in Japan in January 2001, the device is now available throughout Europe and Scandinavia; North, South and Latin America; and Asia and the Pacific Rim.

Medtronic Neurosurgery, based in Goleta, Calif., offers products and technologies used in cranial neurosurgery. Formerly PS Medical, Medtronic Neurosurgery is the market leader in medical technology for the management of cerebrospinal fluid.

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease.

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