Next Generation Carpal Tunnel Release

CarpX* is a minimally invasive device designed to treat carpal tunnel syndrome, allowing the physician to relieve the compression of the median nerve without a traditional surgical incision. CarpX incorporates a balloon catheter with bipolar radio-frequency cutting electrodes. The device is advanced over a wire and positioned in the carpal tunnel under ultrasonic guidance. When activated, it creates space within the tunnel, confirming that the nerve is protected from the cutting electrode and decompressing the median nerve by dividing the transverse carpal ligament. We believe CarpX will have the potential to decrease costs by shifting the procedure from the operating room to a less expensive setting, reduce postoperative pain, accelerate the patient’s return to full activity, and lower the threshold for intervention for patients “suffering in silence” who chose to delay surgery until symptoms become debilitating.

Current Limitations

The treatment for carpal tunnel syndrome patients who have failed to improve with conservative therapy involves cutting the transverse carpal ligament to relieve the compression of the median nerve. Traditional open surgery is effective but invasive. Endoscopic approaches are less invasive but more technically challenging, more expensive and associated with higher complication rates. They also still require a surgical incision and some surgical dissection before the endoscope is passed into the carpal tunnel.

” Carpal tunnel syndrome is the most common cumulative trauma disorder and accounts for half of all occupational injuries in the United States “

Market Opportunity

Carpal tunnel syndrome is the most common cumulative trauma disorder and accounts for half of all occupational injuries in the United States and more than $20 billion in annual workers’ compensation costs. The carpal tunnel is an anatomic compartment in the base of the hand through which tendons and the median nerve pass. Cumulative trauma leads to inflammation which manifests itself clinically through its compressive effect on the median nerve, resulting in motor and sensory dysfunction in the hand. Each year, about 600,000 surgical procedures are performed to treat carpal tunnel syndrome in the U.S., resulting in a market opportunity of at least $1 billion for a device which successfully supplants open surgery.

 

*PAVmed has not yet received clearance from the FDA or any other regulatory agency for the CarpX device.