Medtronic Initiates Phase II Hepatitis C Clinical Study

Medtronic Initiates Phase II Hepatitis C Clinical Study ''COPE-HCV'' to Determine Tolerability and Safety of Continuous Interferon Infusion for Patients with HCV
Wed Sep 2, 2009 11:30am EDT

Medtronic Paradigm Pump Infusion System and CareLink Clinical Monitoring System
Used to Study the Continuous Delivery of INTRON A in Previously Untreated
Genotype 1 Patients

MINNEAPOLIS--(Business Wire)--

Medtronic, Inc. (NYSE: MDT), today reported the initiation and first enrollments
of patients in COPE-HCV (COntinuous Interferon Delivery via the Medtronic
Paradigm Pump Infusion System Clinical Evaluation for Chronic HCV), the
company`s first-ever clinical study using an external pump infusion system to
treat patients with the hepatitis C virus (HCV). The COPE-HCV trial is being
conducted under an Investigational New Drug Application (IND).

COPE-HCV is a Phase II, 250-plus patient study designed to gather clinical data
on the tolerability, safety and efficacy associated with continuous subcutaneous
interferon infusion compared with the current standard-of-care in patients with
HCV genotype 1 infection not previously treated. In the first month of the U.S.
study, 20 patients have been enrolled at six clinical sites in Nashville,
Minneapolis, Atlanta, San Antonio, and Sarasota, Fla. Stage 1 of this randomized
controlled study will include 124 patients at up to 30 sites.

"For years Medtronic has developed drug-delivery systems to bypass traditional
but less effective routes of administration and to help patients with chronic
diseases better manage their conditions," said Bill Hawkins, Medtronic chairman
and CEO. "With this trial now underway, we have the potential to extend our pump
technologies and develop yet another drug-delivery option for a chronic disease
that impacts millions of lives. If successful, this novel therapy will open new
doors to treating other advanced diseases more safely and effectively than
currently available approaches."

The World Health Organization has estimated that three to four million people
become infected by HCV each year and 70 percent of those infected will develop
chronic hepatitis. Standard-of-care for HCV is weekly injections of pegylated
interferon in combination with oral ribavirin medication for up to 48 weeks.
This therapy is only effective in treating approximately 43 percent of all
genotype 1 patients, who represent the overwhelming majority of U.S. hepatitis C
cases. In addition, many patients develop serious side effects from weekly
injections, including chronic fatigue, depression, blood disorders, and flu-like
symptoms.

"There are a host of challenges related to the treatment of HCV that, to this
point, have resulted in less than optimal outcomes and therefore patients are at
a greater risk for developing progressive liver disease," said Dr. John
McHutchison, associate director of the Duke Clinical University Research
Institute (DCRI) and lead investigator of the Medtronic-sponsored study.
"However, the innovative strategy that will be studied in the COPE HCV study may
ultimately be shown to improve both efficacy and tolerability over currently
available drug formulations."

The COPE-HCV study uses the Medtronic Paradigm Infusion System, a device
currently approved by the U.S. Food and Drug Administration for delivering
insulin in patients with diabetes. It also incorporates the use of Medtronic`s
CareLink remote data management system to ensure patients enrolled in the study
are compliant to study protocol for the trial period. The COPE-HCV study will
deliver INTRON A, via the Paradigm pump in combination with oral REBETOL. The
comparison group in the study will use PegIntron and REBETOL. All drugs in the
trial are manufactured and marketed by Schering-Plough.

About Medtronic Drug-Device Delivery Innovations
A pioneer of drug delivery systems, Medtronic recently announced new
developments in its long-standing goal to create a "closed-loop" diabetes
management system designed to closely mimic the insulin delivery of a normal
pancreas. In addition, the company provides its SynchroMed II implantable, drug
infusion system for the treatment of chronic, intractable pain, or to deliver
ITB TherapySM (Intrathecal Baclofen Therapy) to treat severe spasticity related
to brain injury, cerebral palsy, multiple sclerosis, spinal cord injury, or
stroke.

About Hepatitis C
Hepatitis C is a blood-borne liver disease that can lead to chronic liver
disease, liver cancer, cirrhosis, and death. The virus affects an estimated 3.2
million people in the United States alone and some 170 million worldwide.

About Medtronic
Medtronic, Inc. (www.medtronic.com), 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 24, 2009. Actual results may differ materially from anticipated results.





Medtronic, Inc.
Public Relations:
Chuck Grothaus, 763-505-2614
or
Investor Relations:
Jeff Warren, 763-505-2696