Diaphragm Pacing System Gets FDA Nod for ALS

Susan Jeffrey

September 30, 2011

September 30, 2011 — The US Food and Drug Administration (FDA) has granted approval for the use of the NeuRx Diaphragm Pacing System to aid breathing in patients with amyotrophic lateral sclerosis (ALS). The system is approved for use in patients with chronic hypoventilation and a diaphragm amenable to stimulation, notes a statement from the manufacturer, Synapse Biomedical.

The FDA humanitarian device exemption approval is based on the results of a multicenter clinical trial of patients with ALS and chronic hypoventilation. Results showed improved survival and quality of life, including improved sleep, with the device over the current standard of care.

NeuRx Diaphragm Pacing System

The system is already approved under a humanitarian device exemption for use in patients with spinal cord injury who are 18 years of age or older and who lack control of the diaphragm, to reduce the need for ventilator support. It also received CE Mark approval in Europe in 2007, the company statement notes. A list of European centers offering the treatment is found on the manufacturer's Web site.

As the disease process in ALS progresses, the phrenic nerve in the diaphragm fails, and patients lose the ability to breathe without ventilator support. Of 5600 new cases diagnosed each year, an estimated subset of 3300 patients with both respiratory failure and an intact phrenic nerve could benefit from this therapy, the company statement notes.

The device is a 4-channel, battery-powered, external pulse generator with electrodes that are implanted in the diaphragm during a minimally invasive laparoscopic surgical procedure. There, it provides electrical stimulation to the diaphragm muscles. Repeated use of the device conditions the muscles, delaying respiratory failure and the need for tracheostomy and mechanical ventilation, the statement adds.

The company plans to work closely with ALS Association Certified Centers and Muscular Dystrophy Association (MDA)/ALS Centers to make the therapy available as a local option, said Steven Annuziato, senior vice president of marketing and sales at Synapse. "To support immediate treatment requests, we will be working initially with our previous clinical trial center investigators," he noted in the release. A list of these centers is also found on the manufacturer's Web site.

"This is excellent news, indeed, for ALS patients, their caregivers, and for health care providers in general who treat ALS patients," said University of Vermont ALS Association Certified Center Medical Director Rup Tandan, MD, FRCP, in the company's statement. The availability of the device to appropriate ALS patients," he notes, "is a major advance in the treatment of the disease that will enhance survival and quality of life in ALS patients."

"The ALS Association is proud to support The ALS Association Certified Centers and their participation in clinical trials," said ALS Association President and Chief Executive Officer Jane Gilbert in the Synapse release. "We are excited about the potential this therapy offers to help improved quality of life options available for those living with ALS."

"Approval of NeuRx [Diaphragm Pacing System], with its potential to improve both survival and quality of life, is great news for the ALS community," said Valerie Cwik, MD, the MDA's medical director and executive vice president, research. "MDA is very pleased that NeuRx [Diaphragm Pacing System] will now be a treatment option for individuals with ALS across the United States."

"Getting this device was one of the best decisions I've made since my diagnosis," added Augie Nieto, cochair of the MDA's ALS Division and chief inspiration officer of Augie's Quest, who also has ALS. "It helped me delay the need for a tracheostomy until this summer, more than 6 years after my diagnosis," he noted.

"The operation was simple, and I had no trouble with the pacer since it was installed," Nieto said. "Most people with ALS ultimately will face a decision about going on a vent. The pacer will help extend that decision while we help find a cure."

Fifteen years ago, Raymond Onders, MD, cofounder of Synapse Biomedical, who currently holds the Margaret Walter Remen chair in surgical innovation and is a professor of surgery at Case Western Reserve University School of Medicine, Cleveland, Ohio, began clinical research at University Hospitals Case Medical Center to help patients with spinal cord injuries breathe, including the late actor Christopher Reeve, the statement adds. In 2004, this research expanded to include patients with ALS.

ALS has affected Dr. Onders and his family personally, the release notes. "I lost my sister to this devastating disease this past year," Dr. Onders notes in the release. "I have also seen the significant benefit diaphragm pacing can provide to patients. Diaphragm pacing has improved the breathing and longevity of many of the patients I have treated. As medical researchers, we are committed to searching for the cure for ALS but until then, this approval allows us to help these patients."

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