SPR Therapeutics Receives 510(k) Clearance of Technological Advancements and an Expanded Intended Patient Population for the SPRINT® PNS System
CLEVELAND, Feb. 03, 2023 (GLOBE NEWSWIRE) -- SPR Therapeutics, a private medical device company focused on treating pain and improving the quality of life for patients managing acute or chronic pain, announced it has obtained clearance from the U.S. Food and Drug Administration (FDA) for expanded labeling, which increases the intended patient population of the SPRINT® PNS System, along with new advances to enhance and simplify the SPRINT PNS System’s lead securement mechanism.
The patient population that can be treated using SPRINT PNS has expanded to include those age 18 and up, previously age 21 and up, increasing the number of patients that can benefit from this unique approach to peripheral nerve stimulation.
The indication for use was updated to clarify that while the SPRINT PNS System is not intended to be placed in the region innervated by the cranial and facial nerves, it can be utilized to address pain experienced in those regions via leads placed in the back of the head and neck, such as the occipital and cervical medial branch nerve region. Pain in the head and neck can be debilitating for patients and real-world data evaluating SPRINT PNS for the treatment of chronic head and neck pain indicates a significant response following 60-day treatment. SPRINT PNS is the only implantable PNS system that enables on-label stimulation of the occipital nerve for the treatment of chronic pain.
Additionally, the new lead securement component kit provides physicians with an improved method to secure the lead once it has been implanted and makes care of the device even easier for patients during their temporary, 60-day treatment period.
“Our objective is to stay at the forefront of PNS innovation to reduce or eliminate pain, while minimizing opioid treatments and the need for more destructive or invasive interventions. These labeling changes open the door to effectively reach younger patients that can benefit from our breakthrough treatment,” said Dr. Marc Huntoon, Director of Medical Affairs at SPR Therapeutics. “We are a company driven by clinical research and devoted to improving the lives of people living with pain while anticipating the needs of our physician partners. These advances will help us continue to get patients back to their lives and activities that mean the most to them.”
Supporting its commitment to innovation, SPR added 17 new issued and pending patents to its portfolio in 2022 and holds an extensive peripheral nerve stimulation patent portfolio reflecting its unique technology and proprietary approach to pain management.
About the SPRINT PNS System
The SPRINT® PNS System, by SPR® Therapeutics, marks an innovative shift in the treatment of pain. Our breakthrough, 60-day treatment is a First-Line™ PNS option uniquely proposed to recondition the central nervous system to provide significant and sustained relief from chronic pain — without a permanent implant, nerve destruction or the risk of addiction. The system has been studied extensively for low back pain, shoulder pain, post-amputation pain, and chronic and acute post-operative pain, is cleared for use up to 60 days, and is recognized by leading pain management centers. Market research indicates that this breakthrough neuromodulation treatment is a patient-preferred alternative to more invasive options.
The SPRINT PNS System is indicated for up to 60 days for: Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain; symptomatic relief of post-traumatic pain; symptomatic relief of post-operative pain. The SPRINT PNS System is not intended to be placed in the region innervated by the cranial and facial nerves.
Physicians should use their best judgment when deciding when to use the SPRINT PNS System. For more information see the SPRINT PNS System IFU. Most common adverse events are skin irritation and erythema. Results may vary. Rx only.
For additional information regarding safety and efficacy, visit: SPR Safety Information.
About SPR Therapeutics, Inc.
SPR Therapeutics is a privately held medical device company, providing patients with a non-opioid, minimally invasive pain treatment option. Our SPRINT® PNS System fulfills a critical unmet need for a drug-free, surgery-free option for millions who suffer from chronic pain. Backed by the largest body of clinical evidence in peripheral nerve stimulation for the treatment of pain, SPR has demonstrated commercial demand in untapped peripheral (shoulder and knee) and back pain markets and built an incredibly strong foundation for commercial growth. Headquartered in Cleveland, OH with satellite offices in Chapel Hill, NC and Minneapolis, MN, SPR’s Senior Management team includes experienced industry veterans with nearly 200 years of collective pain market and MedTech expertise, all driven by our purpose – to improve the quality of patients’ lives by providing them with a minimally-invasive, drug-free, surgery-free solution to manage their acute and chronic pain.
More information can be found at www.SPRTherapeutics.com.
CONTACT: SPR Contacts: Michelle McDonald Vice President – Marketing firstname.lastname@example.org 844.378.9108 Dave Folkens Public Relations email@example.com 612.978.6547