World’s First Implantation of SPR(TM) System for Chronic Pain
CLEVELAND, Oct. 20, 2011 /PRNewswire-USNewswire/ — A 76-year-old man suffering from agonizing post-stroke shoulder pain for more than ten years is now pain-free, thanks to the world’s first implantation of an investigational pain therapy device from SPR(TM) Therapeutics.
The implant was placed at Carolinas Medical Center and the patient was treated at Carolinas Rehabilitation in Charlotte, North Carolina as part of a multi-center clinical study for the treatment of post-stroke shoulder pain sponsored by NDI Medical, LLC, also involving MossRehab in Philadelphia, Weill Cornell Medical Center in New York City, and MetroHealth Medical Center in Cleveland.
“This is the first promising pain treatment technology designed to reduce or eliminate the excruciating shoulder pain that many stroke survivors suffer from,” said Dr. Vu Q.C. Nguyen, MD, Director of Stroke Rehabilitation at Carolinas Rehabilitation and principal investigator of the clinical study. “This study will enable us to evaluate whether this advanced technology has come up to the level to meet our patients’ needs.”
The study participant was given SPR’s short-term, temporary therapy in September 2010 which significantly reduced his pain after just a few weeks. In December 2011, Dr. William Bock, M.D., cardiologist at Carolinas Medical Center then implanted SPR’s fully implantable device in the patient, who was pain-free within a few weeks of this surgery. He has been pain-free since then, except for a short period in February through April 2011 when the system was turned off due to an unrelated illness. Within a few weeks of the system being turned back on, the patient’s shoulder pain was completely eliminated.
The patient’s overall quality of life has also improved, including improvements in his sleep, mood, and relationships with others, according to study measures. The clinical study is evaluating the safety and effectiveness of this fully implantable therapy in a group of subjects with post-stroke shoulder pain, and the results experienced by the first subject are very encouraging.
Shoulder pain is a common complication following stroke, affecting almost one third of stroke survivors. Yet, post-stroke shoulder pain has not been adequately addressed by traditional treatment options such as local injections, oral analgesics, physical and occupational therapies, acupuncture, and surface neuromuscular electrical stimulation.
The investigational SPR(TM) System uses a proprietary method of Intramuscular Nerve (IMN(TM)) Therapy which stimulates peripheral nerves within muscle to treat pain, and is being studied in patients who are unresponsive to or cannot tolerate these conventional therapies. There are risks associated with participating in the study and receiving the SPR System, and study subjects are informed of all the potential risks before enrolling in the study.
“The implantation of our first fully implantable SPR System for chronic pain is a significant milestone for the treatment of post-stroke shoulder pain and potentially other pain indications in the future,” said Maria Bennett, MS, President and CEO of SPR(TM) Therapeutics. “Relief of shoulder pain is critical in improving these patients’ lives.”
SPR Therapeutics has developed the SPR System (an investigational device that is limited by U.S. law to investigational use): a two-stage system for the treatment of chronic pain, using the Smartpatch(TM) short-term system in the first stage, and a fully implantable MicropulseÃ‚® long-term implant system in its second stage. The System is non-narcotic and reversible, lead placement in muscle is minimally invasive and visual muscle activation confirms target lead location without imaging.
The SPR System could “potentially revolutionize the treatment of chronic shoulder pain,” according to Dr. John Chae, MD, MS, SPR(TM) Therapeutics’ chief medical advisor and professor of Physical Medicine and Rehabilitation at Case Western Reserve University and MetroHealth Medical Center. “Additional studies are being initiated to evaluate this therapy in subjects with shoulder pain that is not related to stroke.”
About SPR(TM) Therapeutics
SPR(TM) Therapeutics (Stimulation for Pain Relief) is a medical device company that is commercializing pain treatments utilizing its proprietary peripheral nerve stimulation devices. SPR(TM) Therapeutics was formed in January 2010 as a portfolio company of NDI Medical, LLC, a leading venture capital and commercialization firm that focuses on innovative neurodevice technologies to address significant unmet health conditions. For more information, visit www.sprtherapeutics.com.
About Carolinas Rehabilitation
Founded in 1950, Carolinas Rehabilitation has 192 rehabilitation beds, including 90 at the main Carolinas Rehabilitation facility, located on the campus of Carolinas Medical Center. The total also includes 39 beds at CMC-Mercy, 40 beds at Carolinas Rehabilitation – Mount Holly, 10 beds at Stanly Regional Medical Center and 13 pediatric beds at Levine Children’s Hospital. Carolinas Rehabilitation also has eleven outpatient rehabilitation locations.
SOURCE SPR Therapeutics