FDA Approves Medical Device From AMES Technologies for Muscle and Joint Rehab After A Stroke or Relatibve Spinal Cord Injuries
Posted May 31 2013 12:11pm
Thus far the website does not have a lot of information posted being the approval just took place with the FDA. It even has audit tables to give insurers and others progress reports on patient progress. I guess this way with the reports there should be no question on the progress made by each patient using the device after having suffered a stroke. The company also partners with NASA and you can read more here about their work together. AMES appears to have several joint projects with NASA. More information about the device at the original story link below. BD
AMES is an Oregon Health & Science University spinoff company established to transform Dr. Cordo's OHSU research findings into a rehabilitation medical device for use in hospitals and clinics. Today's FDA clearance allows AMES to market and sell the device. AMES anticipates delivering the device to hospitals and clinics in early 2014. The typical patient population that possibly receive treatment with an AMES Device would include stroke victims and patients with partial injuries to the spinal cord injury patients. The AMES rehabilitation medical device uses robotic technology to assist a patient in moving the affected limb while vibrating the muscle receptors at the same time. During use, the patient's input effort and other parameters important in therapy are measured and recorded by the AMES Device and displayed to the patient as real-time visual biofeedback. The AMES Device can also perform several diagnostic tests each time a patient is treated by the device to track progress for clinicians and insurance providers.
A series of clinical studies with the AMES Device were conducted at multiple sites across the United States, some with chronic and sub-acute stroke patients and some with chronic spinal cord injury victims. These studies have provided clinical evidence that the AMES approach improves movement and strength in people with injuries to the brain and spinal cord, in some cases restoring the ability to carry out independent activities that were previously unattainable. The studies included treating the arm, hand and the leg. Most of the participants who were enrolled in these studies were considered to be very disabled when they started AMES treatment.
OHSU and Dr. Cordo have a significant financial interest in AMES Technology, Inc., a company that may have a commercial interest in the results of this research and technology. This potential individual and institutional conflict of interest has been reviewed and managed by OHSU.