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Prescriptions Blog: F.D.A. Approves Breathing Device for A.L.S. Patients PDF Print E-mail

The Food and Drug Administration has approved a device that stimulates the diaphragm to assist breathing for some people with amyotrophic lateral sclerosis, better known as A.L.S. or Lou Gehrig’s disease.

The battery-powered device was approved under a Humanitarian Device Exemption, as it had been previously for patients with spinal cord injury, including the actor, Christopher Reeve.

The exemption allows approval for some medical devices affecting 4,000 or fewer people without having to prove effectiveness if the F.D.A. determines benefits probably outweigh the risks. The device, called a diaphragm pacing system, is intended to reduce dependency on mechanical ventilators.

“We are excited about the potential this therapy offers to help improved quality of life options available for those living with A.L.S.,” Jane Gilbert, president and chief executive of the ALS Association, a Washington-based nonprofit advocacy group, said in a statement.

The device includes four electrodes implanted in the diaphragm to stimulate the muscle and mimic natural breathing. Synapse Biomedical of Oberlin, Ohio, said approval was based on clinical trials it financed for 86 patients with A.L.S. and a condition called chronic hypoventilation.

A.L.S. is an incurable disease leading to paralysis. Of the 30,000 people with A.L.S.. in the United States, the company estimated 3,300 could benefit from the device because they have respiratory problems and the necessary intact nerves.

Synapse will provide it to hospitals at a cost of $21,250, company spokeswoman Bethany Hilt said. Hospital charges vary.

The F.D.A. requires the company to track all its implanted devices and conduct a further study of at least 60 patients for at least two years.

The F.D.A. letter was dated Wednesday from Center for Devices and Radiological Health. The company announced the approval on Thursday.

“In granting approval, it allows us to now offer individuals living with A.L.S. more time to be able to breathe with their own muscles,” Anthony R. Ignagni, president and chief executive officer of Synapse, said in a statement.

Read more http://feeds.nytimes.com/click.phdo?i=90f0b8c0d02d70ac082c99b1092aa7cf