Coastal Orthopedics Research Assists with FDA Approval for SCS Treatment of PDN

Business

Coastal Orthopedics, an orthopedic surgery practice whose physicians specialize in orthopedics and pain management, alongside surgical device vendor Nevro Corp., recently announced the receipt of FDA approval of a Spinal Cord Stimulation (SCS) treatment of Painful Diabetic Neuropathy (PDN). Specifically, the approval is for Nevro’s 10kHz stimulation and is now the only SCS system approved by the FDA with a specific indication to treat PDN for long-term relief. 

Prior to receiving FDA approval for this new system, Coastal Orthopedics’ Dr. Richard H. Bundschu, and Dr. Gennady Gekht, pain management specialists, together with the research department at the practice took part in the largest study to date for SCS treatment of PDN. This study focused on alternate treatment options as Dr. Bundschu and Dr. Gekht recognized that there was a need to change the way patients were treated for this condition since neuropathic pain medications can lead to significant side effects. 

“People with chronic PDN know it is a cruel addition to the chronic disease they have to fight daily,” said Dr. Bundschu. “This new treatment is a comprehensive solution that includes the insertion of the Senza spinal cord stimulation system into the patient in a minimally invasive procedure. It delivers mild pulses at a high frequency directly to the spinal cord to stop pain signals from reaching the brain. There is no other treatment or therapy like this, so having the ability to offer it to my Bradenton and Sarasota patients is an incredible opportunity.”

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