First Dual-Lead Nerve Stimulator for Pain Management gets FDA Nod

August 22, 2018  Source: FiercePharma 368


SPR Therapeutics’ single- and dual-lead peripheral nerve stimulation devices win FDA nod as minimally invasive, non-opioid alternatives to treat acute chronic, postoperative and post-traumatic pain when implanted for up to two months.

The Sprint system, owned by SPR Therapeutics, comprises Endura, a single-lead device and the Extensa, market’s foremost double-lead device which enables physicians to manage cases by targeting two nerves in patients nursing wider injuries.

Leads are placed percutaneously in the back or extremities by the physician, as part of a clinical procedure not involving surgical incisions or anesthesia, while a sole, wearable electronic pulse initiator powered by rechargeable batteries and a remote control functioning via Bluetooth.

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.

At the end of the procedure, all parts of the device are removed, differing from other PNS systems requiring a permanent implant. SPR had attained a 510(k) approval in June 2016 for a 30-day regimen.

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.

Early findings from a federally funded study of the system conducted on chronic post-amputation pain revealed a considerable decrease of at least 50% in two-thirds of patients post 8 weeks of treatment. Moreover, long-lasting pain relief was noted in four out of five patients who finished a 12-month study, maximum of which included implantation of dual leads in the hip and thigh, as per SPR.

By Ddu

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