Mainstay Medical’s Reactiv8 restorative neurostimulation device for chronic lower back pain earned favorable coverage from Blue Cross Blue Shield of North Dakota, according to a Feb. 6 news release.
Under its policy BCBS of North Dakota considers Reactiv8 to be medically necessary under criteria including a diagnosis of lumbar multifidus muscle dysfunction and patient selection criteria consistent with FDA approval guidelines and Mainstay’s clinical trial protocols.
“We are pleased that another Blue Cross Blue Shield payer has joined Anthem in making ReActiv8 available to well-selected patients after reviewing the large body of clinical evidence we have built,” Jason Hannon, CEO of Mainstay Medical, said in the release. “Patients with intractable chronic low back pain are desperately seeking durable solutions, and ReActiv8 has proven to be a safe and effective solution through six clinical studies with 633 patients treated and 1,950 patient-years of follow-up, including two multi-center, randomized controlled clinical studies.”
