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A Medical Device for Preventing Paralysis

Organization:Yale University, CT, US
I.P. Brief:A simple medical device has been invented to protect the spinal cord from injury and consequent paralysis resulting from surgery or trauma. This simple-to-use system utilizes cooling, which has a well-established protective benefit, to protect the spinal cord.
Summary of I.P.:The device consists of a disposable, completely self-contained catheter coupled to a control console. The catheter is inserted into the intrathecal space and re-circulates cooled sterile saline. The device was invented by Dr. John Elefteriades, a world leader in aortic surgery, for preventing paralysis in patients undergoing aortic procedures. The device may also be useful in reducing paralysis resulting from other procedures involving the spinal cord, as well as from trauma. Testing in large animal models has shown efficacy in reducing the temperature of the spinal cord to a degree consistent with protection in humans. This novel technology promises to reduce a severe complication of surgery that has plagued surgeons and adversely impacted patient lives for decades.
Keywords:medical device, catheter, cooling, paralysis, spinal cord, spine, surgery
Primary Industry:Health & Medical Devices
Specific Market:Medical Devices, Catheters, Cooling systems
Market Size:Estimates of total market size are 100,000 procedures annually. Even a small reduction in paralysis would lead to rapid adoption/coverage by insurers. If the device can reduce intracranial temperature, it would be possible to obtain an indication for
State of the Art:There are currently no medical devices that reduce risk of paralysis in these procedures.
Figures of Merit:Benefits include: -disposability (repeat sales) -ease-of-use (same placement as epidural, which anesthesiologists routinely perform) -safe (no damage observed upon histological exam in large animal testing) -quick route to FDA approval (an intrathecal catheter is already in place during aortic procedures) -first-to-market opportunity (no competing devices exist)
Tech.  Obstacles:The device has been tested in bench systems as well as in animal models. Human testing will be pursued in the near future. A utility patent application has been filed.
Market Obstacles:- conduct additional animal trials (for efficacy, intracranial cooling - have prototype suitable for human use manufactured - conduct human safety trials - file 510K for FDA approval - commercial launch
Publications:Scientific American 2005
Research Team:Dr. John Elefteriades is one of the leading cardiothoracic surgeons in the world. He is consistently named as one of the top doctors in the U.S.


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