Navigation Links
FDA approves NeuRx diaphragm pacing system for use in spinal cord- injured patients

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

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
University Hospitals of Cleveland

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:
(Date:11/28/2015)... ... ... Beginning November 30th at 6:00 a.m. EST until 11:59 p.m. EST, customers ... up to 20% off orders $80 or more to free gifts with purchases, there will ... As a competitive e-commerce website for skin care and cosmetic needs, customers will save on ...
(Date:11/27/2015)... (PRWEB) , ... November 27, 2015 , ... According to ... are not changing the way that they are handling security in light of the ... and security presence in an attempt to stop an attack from reaching U.S. soil. ...
(Date:11/27/2015)... , ... November 27, 2015 , ... Lizzie’s Lice Pickers ... company is offering customers 10% off of their purchase of lice treatment product. In ... full price. According to a company spokesperson. “Finding lice is a sure way to ...
(Date:11/27/2015)... Wilmington, DE (PRWEB) , ... November 27, 2015 ... ... a member of the well-respected Microsoft Dynamics SL User Group (MSDSLUG). Recognized as ... is an independent group of Microsoft Dynamics SL software users, partners, industry experts ...
(Date:11/27/2015)... ... November 27, 2015 , ... The men and ... nonprofit healthcare organizations in the country. They have overseen financial turnarounds, shown commitment ... advance the healthcare industry as a whole through their advocacy and professional efforts. ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... 26, 2015 Research and Markets ( ... Wound Care Market by Type (Dressings, Therapy Devices, Active ... Facility, Out-Patient Facility), and Geography - Global Forecast to ... --> --> The purpose of ... forecast of the global advanced wound care market. It ...
(Date:11/26/2015)... 26, 2015 ... adds "Global Repaglinide Industry 2015 ... on China Repaglinide Market, 2010-2019" reports ... and information to its online business ... . --> ...
(Date:11/26/2015)... 2015 Research and Markets ( ... "2016 Future Horizons and Growth Strategies in the ... Country Segment Forecasts, Competitive Intelligence, Emerging Opportunities" ... --> --> This new 247-page ... therapeutic drug monitoring market, including emerging tests, technologies, ...
Breaking Medicine Technology: