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
www.synapsebiomedical.com
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.
Source: University Hospitals of Cleveland
Related stories:
Study challenges routine use of MRI scans to evaluate breast cancer
A new study suggests women with newly-diagnosed breast cancer who receive an MRI after their diagnosis face delays in starting treatment and are more likely to receive a mastectomy. The study, presented today at the 2008 ASCO Breast Cancer Symposium, also shows that despite lack of evidence of their benefit, the routine use of MRI scans in women newly diagnosed increased significantly between 2004 and 2005, and again in 2006.
Patients will face delays in getting diagnostic scans due to severe shortage of imaging agents
A global shortage of medical isotopes* used in over 80% of routine diagnostic nuclear imaging procedures such as heart imaging, bone scans and some cancer detection procedures, will cause delays and cancellations to diagnostic examinations across the UK and Europe in the next few weeks, predict experts on bmj.com today.
FDA posts list of potential problem drugs
(AP) -- The government on Friday began posting a list of prescription drugs under investigation for potential safety problems, in an effort to better inform doctors and patients.
Best way to treat malaria: Avoid using same drug for everyone, scientists say
(PhysOrg.com) -- A team of scientists employing a sophisticated computer model pioneered at Princeton University and Resources for the Future has found that many governments worldwide are recommending the wrong kind of malaria treatment.
1 step back ... 2 steps forward
Women with hormone-receptor positive, metastatic breast cancer may take medications for years to help keep their cancer at bay, but when the tumor becomes resistant to anti-hormonal drugs, treatment with chemotherapy becomes the only option. But a study presented today at the 2008 ASCO Breast Cancer Symposium may change this approach. Early data suggests a new treatment approach can "re-sensitize" the tumor, allowing anti-hormonal drugs to do their job once again.
Computerized reminder system drove up colon cancer screening rates, study found
A computerized reminder system used in community-based primary care doctors' offices increased colorectal cancer screening rates by an average of 9 percent, according to a new study from the University of Michigan Health System.
Free drug samples may end up costing uninsured more
Free drug samples provided to physicians by pharmaceutical companies could actually be costing uninsured patients more in the long run, according to a study done by researchers at Wake Forest University Baptist Medical Center and colleagues.
Living donor liver transplants may drastically decrease mortality from liver failure
Patients with acute liver failure (ALF) could be saved by a transplant from a living donor (LDLT), according to a new study in the September issue of
Liver Transplantation, a journal by John Wiley & Sons. The recent experience of U.S. patients shows that recipient mortality rates and donor morbidity rates are acceptable.