FDA clears first dual-lead nerve stimulator for pain relief | Digital Science
The FDA granted clearance to SPR Therapeutics’ single- and dual-lead peripheral nerve stimulation devices as minimally invasive, non-opioid alternatives, implanted for up to 60 days for relieving acute and chronic pain, including postoperative and post-traumatic pain.
The Cleveland-based company’s Sprint system includes the single-lead Endura and the industry’s first dual-lead device, Extensa, which allows physicians to deliver therapy to two nerve targets in patients with broader injuries.
Percutaneous leads are placed by a physician in the back or extremities during an outpatient procedure without surgical incisions or anesthesia, while a single, wearable electronic pulse generator features rechargeable batteries and a Bluetooth-enabled remote control.
“Our Sprint PNS platform is designed to deliver the least invasive and most user-friendly PNS therapy experience for physicians and their patients,” SPR’s founder, president and CEO, Maria Bennett, said in a statement.
All of the device components are removed at the end of the treatment period, compared to other PNS systems that may require a permanent implant. SPR previously obtained a 510(k) clearance in June 2016 for a 30-day regimen.
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“With the ease of use and dual lead capabilities we’ve built into the SPRINT System we look forward to advancing the early use of neurostimulation as a non-opioid alternative for more patients while we continue to generate data that demonstrate significant and sustained pain relief following our 60-day therapy,” Bennett said.
According to SPR, preliminary results from a federally funded study of the system in chronic post-amputation pain showed significant reductions of at least 50% among two-thirds of patients after 8 weeks of treatment. In addition, long-term pain relief was reported by four of five patients who completed a 12-month study, most of which were implanted with dual leads in the hip and thigh.