Navigation Links
FDA approves NeuRx diaphragm pacing system for use in spinal cord- injured patients
Date:6/18/2008

The U.S. Food and Drug Administration (FDA) has approved the NeuRx Diaphragm Pacing System (DPS) for spinal cord-injured patients who are dependent on ventilators for breathing. The light-weight, battery-powered electronic DPS allows patients to breathe and speak more naturally, while eliminating the need for a power source and concern over power outages.

The system was developed over the course of 20 years through a joint research effort of physicians and engineers, primarily at University Hospitals Case Medical Center, Case Western Reserve University and Louis Stokes Cleveland Veterans Affairs Medical Center, all located in Cleveland. NeuRx DPS is manufactured commercially by Synapse Biomedical, Inc., based in Oberlin, Ohio.

DPS gained national attention in 2003 when University Hospitals Case Medical Center (UHCMC) surgeon Raymond Onders, M.D., implanted the system in actor Christopher Reeve. Dr. Onders is the director of minimally invasive surgery at UHCMC.

"This is a major step in improving the quality of life for patients who have spinal cord injuries and cannot breathe without the help of a ventilator," said Dr. Onders. "Based on testimonials that I've received from patients who have been in the clinical trials, DPS provides patients with a freedom of mobility that they never imagined. They've sent photographs or videos themselves parachuting from planes, sailing solo, or enjoying rides at amusement parks with their families; activities impossible to do with a ventilator."

NeuRx DPS is a technology providing electrical stimulation to muscle and nerves running through the diaphragm, the major muscle involved in breathing. When stimulated by NeuRx DPS, the diaphragm contracts, allowing patients to breathe more naturally than having air forced into their lungs as a mechanical ventilator does.

FDA approval is based on 50 patients implanted with the system at hospitals in the United States and Canada, including UHCMC; Shepherd Center in Atlanta; Methodist Neurological Institute in Houston; and Vancouver General Hospital. Dr. Onders, a founder and shareholder of Synapse, trained all of the implanting surgeons. Dr. Onders will continue to oversee initial surgeries as regional trauma centers are certified to offer the system.

According to information from Synapse, in the DPS clinical trial, more than 50 percent of spinal cord-injured patients were able to completely eliminate their need fro mechanical ventilation.

The system is implanted through minimally invasive laparoscopic surgery. Patients and caregivers who want to find a doctor who can evaluate their case for possible treatment should visit www.synapsebiomedical.com

A clinical trial also is underway testing DPS with patients who have Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's disease. This incurable and fatal neuromuscular disease is characterized by progressive muscle weakness. A pilot study demonstrated the feasibility of DPS to slow the decline of a ALS patients' respiratory function. UHCMC and several other sites in the United States are involved in the study.


'/>"/>

Contact: George Stamatis
george.stamatis@UHhospitals.org
216-844-3667
University Hospitals of Cleveland
Source:Eurekalert

Related medicine news :

1. FDA Approves Cymbalta(R) for the Management of Fibromyalgia
2. ClearWay Minnesota(SM) Board Approves $1.4 Million in New Grants to Reduce Tobaccos Harm
3. FDA Approves AstraZenecas Seroquel(R) for Maintenance Treatment in Bipolar Disorder
4. FDA Approves NOVO NORDISKs NovoSeven(R) RT (Coagulation Factor VIIa [Recombinant] Room Temperature Stable) for Hemophilia Patients With Inhibitors
5. FDA Approves Taclonex Scalp(R) - Once Daily Therapy for Treatment of Moderate to Severe Scalp Psoriasis
6. FDA Approves Health Claim for Brown Rice
7. FDA Approves Strattera(R) for Maintenance of ADHD in Children and Adolescents
8. FDA approves HeartMate II mechanical heart pump for heart-failure patients
9. FDA Approves Advair(R) 250/50 for Reduction of Exacerbations in Patients With COPD
10. FDA Approves New Once-a-Month Dose of Actonel for Postmenopausal Osteoporosis
11. FDA approves VYVANSE, first and only once-daily prodrug stimulant to treat ADHD in adults
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/5/2016)... ... 2016 , ... US Sports Camps , official operators of Nike Yoga ... kids yoga training. ChildLight Yoga Studio is centrally situated in the picturesque New England ... Yoga Studio founder Lisa Flynn expresses her excitement, “We are thrilled to be partnering ...
(Date:2/5/2016)... ... 2016 , ... The American public tends to feel uncomfortable about drinking recycled ... municipal or well water. The recent experience with lead contaminated water in Flint, Michigan, ... way toward increasing public acceptance of recycled waste water as drinking water. , ...
(Date:2/5/2016)... ... February 05, 2016 , ... Give To Cure today announced that ... donate to Give To Cure’s campaign that is crowdfunding clinical trials to help find ... share payments through a smart device. In 2015 alone, Venmo processed $7.5 billion in ...
(Date:2/5/2016)... ... 2016 , ... Pivot Point Consulting, a leading national Healthcare ... Services for HIT Implementation Support & Staffing report with an outstanding score of ... healthcare executives, managers and clinicians representing over 4,500 hospitals and 2,500 clinics. , ...
(Date:2/5/2016)... ... , ... Dr. Justin Scott and Dr. Lydia Muccioli of Pure Dental ... individuals in need. The event is scheduled to take place on February 27, 2016 ... provide dental care to community members in need. Each patient will be given the ...
Breaking Medicine News(10 mins):
(Date:2/5/2016)... 2016 Amgen (NASDAQ: AMGN ) will present ... Conference at 9:15 a.m. ET on Wednesday, Feb. 10, 2016, ... W. Meline , executive vice president and chief financial officer ... the presentation can be accessed from the Events Calendar on ... the webcast will also be available on Amgen,s website for ...
(Date:2/5/2016)... 2016  Patients in Alabama seeking ... therapy no longer have to travel out of state. ... Urology Centers of Alabama to provide a total ... qualifying patients. Alabama is ... of prostate cancer using many different modalities. They are the ...
(Date:2/5/2016)... York , February 5, 2016 ... Transparency Market Research report states that the global active ... 2014 and is predicted to reach US$185.9 bn by ... of 6.50% from 2014 to 2020. The title of ... Chemical/Biological, Captive/Contract Manufactured, by Geography, and by Therapeutic Area) ...
Breaking Medicine Technology: