SPR® Therapeutics Unveils Long-term Data on SPRINT® PNS and Initial MONARCH™ Trial Update
2024年7月15日 - 10:05PM
Five abstracts featuring SPR Therapeutics’ SPRINT PNS System
generated interest from leading pain physicians at the American
Society of Pain & Neuroscience (ASPN) Annual Conference in
Miami.
“Four-Year Follow Up from a Prospective, Multicenter
Study of 60-day Medial Branch Nerve Stimulation for the Treatment
of Chronic Axial Back Pain” was selected as an ASPN Top
Abstract and featured as an oral presentation by Dr. Christopher
Gilmore, MD, of the Carolinas Pain Institute and lead author, who
presented long-term follow-up data from study participants who
received SPRINT PNS for their low back pain. More than two-thirds
(n=15/22) of participants reported clinically significant pain
relief (greater than or equal to 30 percent) an average of 4.7
years after receiving 60-day PNS treatment.
“The long-lasting results we are seeing from SPRINT PNS
participants over four years out from the end of treatment is truly
impressive and makes a strong case for 60-day PNS as it is a
short-term treatment that can deliver significant, sustained relief
according to these data,” said Dr. Gilmore.
The abstract titled “Primary Endpoint Results From a
Prospective Single-Arm Study of 60-Day Peripheral Nerve Stimulation
Treatment Targeting the Occipital Nerves for Head Pain” by
Dr. Jerry Gutierrez, Medical Director of The Pain Relief
Surgicenter and lead author, highlights the first primary endpoint
data from the MONARCH Case Series Study. The MONARCH study is the
first prospective evaluation of 60-day PNS designed to learn more
about relieving headache pain. Eighty-five percent of participants
(n=17/20) reported greater than or equal to 50 percent reductions
in pain and/or pain interference at the end of treatment (EOT).
Additional abstracts featuring SPRINT PNS included-
- “Percutaneous PNS Used for Treatment of Chronic
Shoulder Pain: A Multi-Center Retrospective Chart Review”
(Aman et al.) Overall, 60-day PNS was shown to be an effective
treatment for chronic shoulder pain where 75 percent of patients in
this review with EOT outcomes available (n=132/176) reported
greater than or equal to 50 percent pain relief. These 132 patients
had a variety of shoulder pain causes and treatment histories, with
patients receiving Bimodal PNS® treatment (concurrent motor and
sensory stimulation targeting two nerves) reporting the highest
rates of success.
- “Retrospective Review of 60-day Peripheral Nerve
Stimulation in the Treatment of Complex Regional Pain
Syndrome” (Patel et al.) This review of over 400 CRPS
patients treated with PNS showed that 72 percent were responders
(n=306/424), defined as reporting at least 50 percent pain relief
and/or an improvement in Patient Global Impression of Change (PGIC)
quality of life scores.
- “Percutaneous Peripheral Nerve Stimulation Relieves
Chronic Postoperative Pain and Improves Function After Total Knee
Arthroplasty: Holistic Responders in a Double-blind,
Placebo-controlled Randomized Controlled Trial” (Goree et
al.) In this analysis of holistic improvements in pain relief,
function, walking ability, and/or quality of life for participants
experiencing postoperative pain after knee replacement surgery, a
significantly larger proportion of participants who were treated
with 60-day PNS were holistic responders (with at least 30 percent
improvement from baseline in pain relief and substantial
improvements in at least one additional outcome) compared to those
receiving placebo (sham) stimulation (n=15/20 versus n=7/20;
p<0.05). Outcomes from this multicenter, randomized,
double-blind, placebo-controlled trial were recently published in
the journal Neuromodulation.
The most common adverse events for the SPRINT PNS System in both
clinical studies and real-world data include skin irritation and
erythema. All three clinical studies (Goree et al., Gutierrez et
al., and Aman et al.) reported no study-related serious or
unanticipated adverse events. Safety was not analyzed in the
long-term follow-up survey (Gilmore et al.) and the retrospective
chart review (Patel et al.).
See all five abstracts shared at ASPN by clicking here.
Drs. Gilmore, Gutierrez, Aman, and Patel are consultants for SPR
Therapeutics.
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, knee pain, shoulder pain, post-amputation pain, and chronic
and acute postoperative 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 postoperative 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.
SPR Contacts:Michelle McDonaldVice President –
Marketingmmcdonald@sprtherapeutics.com 844.378.9108
Dave FolkensPublic Relations dfolkens@sprtherapeutics.com
612.978.6547