SPR Therapeutics’ Single- and Dual-Lead Peripheral Nerve Stimulation Devices Pass FDA

Agency grants clearance to minimally invasive, non-opioid alternatives for the relief of acute and chronic pain.

Cleveland-based SPR Therapeutics’ Sprint system is designed to be implanted temporarily, for up to 60 days. It comprises Endura, a single-lead device, and Extensa, the industry’s first dual-lead device. With the dual-lead device physicians are able to deliver therapy to two different nerve targets in patients with broad injuries.

FDA recently granted clearance to the single- and dual-lead peripheral nerve stimulation devices as minimally invasive, non-opioid alternatives for the relief of acute and chronic pain, including postoperative and post-traumatic pain. SPR previously received a 510(k) clearance in June 2016 for a 30-day regimen.

Patients are treated in an outpatient setting. Percutaneous leads are placed in the back, or extremities, without surgical incisions or anesthesia. A wearable electronic pulse generator with rechargeable batteries includes a Bluetooth-enabled remote control. Once the treatment is completed, all components are removed, unlike with other PNS systems that require permanent implants.

According to the company, in a federally funded study of the SPRINT system in chronic post-amputation pain, at least 50% among two-thirds of patients experienced significant reductions of pain by at least 50% after 8 weeks of treatment, and four of five patients reported pain relief after 12 months. Most of these patients had dual leads implanted in both the hip and thigh.

SPR’s founder, president and CEO Maria Bennett noted: “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.

 

 

Cynthia A. Challener, Ph.D.

Dr. Challener is an established industry editor and technical writing expert in the areas of chemistry and pharmaceuticals. She writes for various corporations and associations, as well as marketing agencies and research organizations, including That’s Nice and Nice Insight.

Q: