Navigation Links
Study Supports Cost-Effectiveness of Medtronic's Spasticity,Treatment for Children with Cerebral Palsy

MINNEAPOLIS--(BUSINESS WIRE)--Apr 26, 2007 - A new study published in the current issue of the Journal of Child Neurology indicates that a treatment from Medtronic, Inc. (NYSE:MDT), for spasticity in children with cerebral palsy improves their quality of life and is cost-effective compared to other established cost-effective treatments. The findings of this Medtronic-sponsored study should expand access to the treatment, known as Medtronic ITB Therapy(SM) (Intrathecal Baclofen Therapy).

Cerebral palsy affects an estimated 764,000 people in the United States, according to United Cerebral Palsy, with approximately 8,000 babies and 1,200 to 1,500 preschool-age children diagnosed with the condition each year. Caused by damage to one or more areas of the developing brain, cerebral palsy is characterized by an inability to control motor function fully, particularly muscle control and coordination.

The most common form of cerebral palsy involves spasticity - tight, stiff muscles that make coordinated movement (especially of the arms and legs) difficult or uncontrollable. Up to 80 percent of children with cerebral palsy develop spasticity, which can be painful and limit functional ability for the patient, and tax the patient's family physically, emotionally, and financially.

Medtronic ITB Therapy, which uses the company's SynchroMed(R) implantable infusion system to deliver a muscle relaxant directly to the fluid-filled area surrounding the spinal cord, can effectively reduce severe spasticity with fewer side-effects than oral medication. By reducing spasticity, ITB Therapy may also improve function, quality of life, and ease of care.

Despite the treatment's well-demonstrated clinical efficacy, ITB Therapy remains underused - in large part because of concerns about the cost of the pump and the surgery to implant it.

"The cost of ITB Therapy should not prevent pediatric patients with spastici ty of cerebral origin from receiving this clinically effective treatment," explained Dr. Terence Edgar of the Medical College of Wisconsin's Department of Neurology and senior author of the study. "Specifically, we found that the projected improvement in quality of life justifies the estimated five-year treatment cost based on well-established guidelines for cost-effectiveness."

Dr. Edgar and colleagues, including a team of health economists from United BioSource Corp. in Bethesda, Md., "used mathematical modeling and computer simulation to estimate the incremental cost per quality-adjusted life-year for identical cohorts of children treated with intrathecal baclofen or alternative therapy during a five-year episode of treatment," according to the study abstract. "On average, intrathecal baclofen therapy increased the five-year cost of treatment by $49,000 relative to alternative treatment. However, this was accompanied by an average gain of 1.2 quality-adjusted life-years. The net result was an incremental cost-effectiveness ratio of $42,000 per quality-adjusted life-year, a figure well (below) the $50,000 to $100,000 range that is widely accepted as offering good value for money."

Supported by Medtronic, this analysis of ITB Therapy's cost-effectiveness is the first in the context of the U.S. healthcare system.

"Cost-effectiveness is an important consideration in today's healthcare environment," said Dr. Richard E. Kuntz, M.D., senior vice president of Medtronic, Inc., and president of the company's Neurological business. "This study supports the cost-effectiveness of Medtronic ITB Therapy, an effective treatment for severe spasticity that has the potential to restore functional ability and a better quality of life to thousands of people every year."

Medtronic ITB Therapy is indicated for the management of severe spasticity of cerebral and spinal origin, including stroke, cerebral palsy, brain injury, spinal cord injury, and multiple sc lerosis. It uses Medtronic's SynchroMed Implantable Infusion System, which consists of a programmable drug pump connected to a thin tube, or catheter, to deliver precise amounts of a muscle relaxant called Lioresal(R) Intrathecal (baclofen injection) directly to the intrathecal space - the fluid-filled area surrounding the spinal cord, the drug's site of action. By targeting the spinal cord, ITB Therapy reduces spasticity with smaller amounts of medication than would be required orally. Intrathecal infusion, which bypasses the body's blood-brain barrier, also minimizes systemic side-effects.

ITB Therapy drug side effects are usually temporary and manageable by adjusting the dose. The most common side effects include loose muscles, drowsiness, nausea/vomiting, headache, and dizziness. Abrupt discontinuation of intrathecal baclofen, regardless of the cause, can result in high fever, altered mental status, returned spasticity, and muscle rigidity, and in rare cases has been fatal. Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms.

Children should be of sufficient body mass to accommodate the pump. The safety and efficacy of ITB Therapy in pediatric patients below the age of four have not been established.

More information about ITB Therapy is available online at www.spasticity.com or by calling toll-free 1-800-856-3823. Other pharmaceutical treatments for spasticity include oral and injectable medications.

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 28, 2006. Actual results may differ materially from anticipated results.

Lioresal(R) is a registered trademark of Novartis Pharmaceuticals Corporation.

Contact

Medtronic, Inc.
Investor Relations:
Jeff Warren, 763-505-2696
or
Public Relations:
Joe McGrath, 763-505-0291


'"/>




Related medicine technology :

1. Data Available From Erbitux Phase III Study in First-Line Treatment of Advanced Lung Cancer
2. Clinical Study Shows Regenecare Relieves Pain and Itching of Skin Rashes Caused by Widely Used Cancer Drugs
3. Cell Therapeutics, Inc. Management to Discuss Todays Announcement of Interim Pixantrone Study Results
4. Biofrontera AG Announces Clinical Study Confirms Excellent Efficacy of BF-200 ALA In Actinic Keratosis
5. Reaction to Avandia Warnings Stronger Among Internists Than Endocrinologists, According to Study by GfK Market Measures
6. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
7. Actemra (tocilizumab) Third Phase III Study Results Show Significant Improvement in Symptoms of Patients with Rheumatoid Arthritis
8. Protox Announces Positive Clinical Data from Prostate Cancer Study
9. International ENDORSE Study Shows That the Majority of Hospitalized Patients Surveyed are at Risk for VTE and Many do not Receive Recommended VTE prophylaxis
10. New Study Shows That Extending Prophylaxis With Clexane / Lovenox (enoxaparin Sodium Injection) to 5 Weeks is More Effective Than 10 Days for Reducing the Risk of Venous Thromboembolism (VTE) in Acutely ill Medical Patients With Reduced Mobility
11. Genzyme Announces Data from First Phase 3 Study of Tolevamer in Patients with C. difficile Associated Diarrhea
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... , June 23, 2016 The vast majority ... outpatient dialysis facility.  Treatments are usually 3 times a ... per visit, including travel time, equipment preparation and wait ... but especially grueling for patients who are elderly and ... skilled nursing and rehabilitation centers for some duration of ...
(Date:6/23/2016)... , June 23, 2016  Experian ... integrating and transforming the patient payment and ... several innovative new products and services that ... its revenue cycle offerings. These award-winning solutions ... efficient workflows, remain compliant in an ever-changing ...
(Date:6/23/2016)...  The National Pharmaceutical Council (NPC) today announced ... research organization as its newest member.  ... president and chief scientific officer, Mallinckrodt Pharmaceuticals, will ... Board of Directors. ... us in support of our efforts to conduct ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... June 27, 2016 , ... ... technology to revolutionize the emergency ambulance transport experience for the millions of people ... how Uber has disrupted the taxi industry through the use of technology. Now, ...
(Date:6/26/2016)... ... June 26, 2016 , ... Pixel Film Studios Released ProSlice Levels, a Media ... give their videos a whole new perspective by using the title layers in ... Studios. , ProSlice Levels contains over 30 Different presets to choose from. ...
(Date:6/25/2016)... ... 2016 , ... Experts from the American Institutes for Research ... June 26-28, 2016, at the Hynes Convention Center in Boston. , AIR experts ... planning, healthcare costs and patient and family engagement. , AIR researchers will be ...
(Date:6/25/2016)... ... June 25, 2016 , ... First Choice Emergency Room , ... Sesan Ogunleye, as the Medical Director of its new Mesquite-Samuell Farm facility. , ... our new Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical Director of First ...
(Date:6/25/2016)... ... ... Conventional wisdom preaches the benefits of moderation, whether it’s a matter of ... too high can result in disappointment, perhaps even self-loathing. However, those who set the ... Research from PsychTests.com reveals that behind the tendency to set low expectations ...
Breaking Medicine News(10 mins):