A device recently approved by the U.S. Food and Drug Administration to help individuals who develop chronic hypoventilation from Amyotrophic Lateral Sclerosis (ALS, also known as Lou Gehrig's disease) is now available at Crestwood Medical Center. Dr. Peter Vevon, a general surgeon in Huntsville, is among the first surgeons in the United States to implant the NeuRx Diaphragm Pacing System (DPS) in patients with ALS and Chronic Hypoventilation. Dr. Vevon is also the first surgeon and Crestwood Medical Center is the first hospital in Alabama to complete the implant.
Dr. Tejanand Mulpur, neurologists and Co-Medical Director of the ALS Care Clinic at Crestwood Medical Center (recently designated as a Certified Treatment Center of Excellence by the ALS Association), explains, "Most ALS patients develop chronic hypoventilation over the course of their disease. Traditionally, we could only assist them with invasive or non-invasive ventilation."
Through clinical review and respiratory testing measures, Carla King was identified as a patient who could potentially benefit from the NeuRx DPS. Ms. King had the procedure completed at Crestwood Medical Center on Tuesday, April 29, 2014 and is doing well with no reported complications. She says, "Being the first in Alabama to have the DPS was exciting and hopeful! The ALS diagnosis is a frightening and helpless feeling, with no cure or treatment really available. This procedure is such a positive for ALS patients resulting in significantly better breathing and therefore, a better quality of life."
Once it was determined that the implant could help Ms. King, Dr. Raymond P. Onders, Director of Minimally Invasive Surgery at University Hospitals Case Medical Center and Professor of Surgery at Case Western Reserve University School of Medicine in Cleveland, Ohio, was contacted to train Dr. Vevon on the procedure. Dr. Onders was the lead principal investigator for the trial leading to the device's FDA approval in 2011.
Dr. Vevon relays "We are excited about offering the benefits of the NeuRx DPS at Crestwood Medical Center, including the opportunity for a patient to breathe for a longer period without needing a mechanical ventilator."
The device, implanted through minimally invasive laparoscopic surgery, provides electrical stimulation to the muscle and nerves in the diaphragm. When the muscle is stimulated by the implant, the diaphragm contracts which helps condition the muscle to improve fatigue resistance during normal exertion.
Describing her experience, Ms. King says, "The ALS Clinic and Association were the sparks that made [the procedure] a reality. They are such advocates for their patients, and eagerly welcomed something 'new.' I cannot thank them enough for giving me this opportunity!"
For more information about this procedure for ALS patients, please contact the ALS Association at 256.519.9030.
THE ALS CLINIC AT CRESTWOOD MEDICAL CENTER is a member of The ALS Association and is affiliate with the Alabama Chapter. The clinic consists of physicians and multidisciplinary team of professionals in the cafe of people with ALS. The clinic was recently designated as a Certified Treatment Center of Excellence by the ALS Association.
Using a form of minimally invasive laparoscopic surgery, a surgeon creates four dime-sized holes in the abdominal region and inserts a laparoscope so the diaphragm muscle can be seen. The surgeon then places small electrodes in the diaphragm. The electrodes are attached through wires under the skin to a small external battery-powered pulse generator that stimulates contraction of the diaphragm muscle. The NeuRx DPS is programmed to allow an effective yet comfortable breath. The patient starts with three 30-minute sessions a day to condition the diaphragm muscle. As ALS progresses, the conditioning time increases.
In the clinical trial, NeuRx DPS was approved by the FDA under a Humanitarian Device Exemption (HDE) marketing approval, based on demonstration of safety and probable benefit (likelihood that it help ALS patients live longer and sleep better than the current standard of care). These findings are the result of a multicenter clinical trial that enrolled 106 ALS patients and treated 86 for chronic hypoventilation. The NeuRx DPS is controlled through a four-channel, battery-powered external pulse generator.Patients and caregivers are easily trained in the use of the device, reducing the need for medical supervision.
For more information about Synapse Biomedical, visit www.synapsebiomedical.com.
Crestwood Medical Center
One Hospital Drive
Huntsville, AL 35801