Navigation Links
Diaphragm pacing system receives FDA approval for use with ALS patients
Date:9/29/2011

An electronic system that stimulates the nerve of the diaphragm muscles has received approval from the Food and Drug Administration (FDA) for use in patients with Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's disease. The system called NeuRx Diaphragm Pacing System (DPS) will help ALS patients breathe longer without the aid of a ventilator.

Dr. Raymond Onders, the surgeon at University Hospitals (UH) Case Medical Center who helped develop and test DPS and who lost his own sister to ALS this past year, began testing DPS 15 years ago on spinal cord injured patients such as the late actor Christopher Reeve. In 2004, this research expanded to included patients with ALS patients whose progressive muscle weakness leads to an inability to breathe without ventilator support.

"I lost my sister to this devastating disease during the FDA approval process," said Dr. Onders. "I also have seen the significant benefit diaphragm pacing can provide to patients. Diaphragm pacing has improved the breathing and quality of life of many of the patients I have treated. I am committed to searching for the cure for this disease but until then and with this approval we are now able to continue helping ALS patients until that cure is found," said Dr. Onders who is Director of Adult Minimally Invasive Surgery at UH Case Medical Center and who holds the Margaret and Walter Remen Chair in Surgical Innovation and is Professor of Surgery at Case Western Reserve University School of Medicine.

NeuRx DPS is made by Synapse Biomedical, Inc., a company co-founded by Dr. Onders.

Anthony R. Ignagni, Synapse's President and Chief Executive Officer, said, "We are very pleased the FDA approved this next indication for use of the NeuRx DPS to treat chronic hypoventation in ALS. In granting approval, it allows us to now offer individuals with ALS more time to be able to breathe with their own muscles."

The FDA granted a Humanitarian Device Exemption based on demonstration that NeuRx DPS could help ALS patients live longer, have better quality of life and sleep better than the current standard of care alone. These findings are the result of a multi-center clinical trial that enrolled 144 patients and treated 88 for chronic hypoventilation at UH Case Medical Center, Johns Hopkins, Stanford University and other major medical centers in the United States and France.

ALS is a rapidly progressing, incurable and fatal neuromuscular disease. As the phrenic nerve to the diaphragm muscles fails, patients have difficulty breathing. About 30,000 people in the United States live with ALS. More than 5,600 new cases are diagnosed each year, with an estimated subset of 3,300 with both chronic hypoventilation and intact phrenic nerves that could benefit from the NeuRx DPS treatment.

In ALS, NeuRx DPS is implanted through minimally invasive laparoscopic surgery and provides electrical stimulation to the diaphragm muscles. Repeated use of DPS conditions the diaphragm muscles, delaying respiratory failure and the need for tracheostomy and mechanical ventilation.


'/>"/>
Contact: George Stamatis
george.stamatis@uhhospitals.org
216-844-3667
University Hospitals Case Medical Center
Source:Eurekalert

Related biology news :

1. Stevens strengthens Dominican Republics Early Warning System for Inundations
2. Meat-eating dinosaur from Argentina had bird-like breathing system
3. New meat-eating dinosaur from Argentina had bird-like breathing system
4. Genetic finding implicates innate immune system in major cause of blindness
5. RNA molecules, delivery system improve vaccine responses, effectiveness
6. New Systems Biology Awards enable detailed study of microbes
7. Caltech scientists engineer supersensitive receptor, gain better understanding of dopamine system
8. UGA study reveals ecosystem-level consequences of frog extinctions
9. Scripps research team sheds light on immune system suppression
10. Global Viral Forecasting Initiative receives $11M to implement pandemic early warning system
11. Evolved Machines Selected as a Prime Contractor for DARPA Program to Engineer an Artificial Olfaction System
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/3/2016)... , June 3, 2016 ... von Nepal hat ... Lieferung hochsicherer geprägter Kennzeichen, einschließlich Personalisierung, Registrierung ... in der Produktion und Implementierung von Identitätsmanagementlösungen. ... Ausschreibung im Januar teilgenommen, aber Decatur wurde ...
(Date:6/2/2016)... --  The Weather Company , an IBM Business (NYSE: ... in which consumers will be able to interact with IBM ... voice or text and receive relevant information about the product ... have long sought an advertising solution that can create a ... and valuable; and can scale across millions of interactions and ...
(Date:6/1/2016)... June 1, 2016 Favorable Government ... Administration and Criminal Identification to Boost Global Biometrics System ... released TechSci Research report, " Global Biometrics Market ... Forecast and Opportunities, 2011 - 2021", the global biometrics ... 2021, on account of growing security concerns across various ...
Breaking Biology News(10 mins):
(Date:6/27/2016)... ... 27, 2016 , ... Parallel 6 , the leading software as a ... Reach Virtual Patient Encounter CONSULT module which enables both audio and video telemedicine ... team. , Using the CONSULT module, patients and physicians can schedule a face to ...
(Date:6/27/2016)... , June 27, 2016  Liquid Biotech ... the funding of a Sponsored Research Agreement with ... tumor cells (CTCs) from cancer patients.  The funding ... CTC levels correlate with clinical outcomes in cancer ... data will then be employed to support the ...
(Date:6/24/2016)... SAN DIEGO , June 24, 2016 /PRNewswire/ ... that more sensitively detects cancers susceptible to PARP ... individual circulating tumor cells (CTCs). The new test ... of HRD-targeted therapeutics in multiple cancer types. ... therapies targeting DNA damage response pathways, including PARP, ...
(Date:6/23/2016)... ... 2016 , ... Mosio, a leader in clinical research patient ... and Retention Tips.” Partnering with experienced clinical research professionals, Mosio revisits the hurdle ... and strategies for clinical researchers. , “The landscape of how patients receive and ...
Breaking Biology Technology: