SPRINT® PNS Demonstrates Robust Results in Addressing Chronic Shoulder Pain
2024年8月6日 - 10:00PM
A new real-world retrospective analysis evaluating quantifiable
improvements in multiple domains of health in patients who received
60-day peripheral nerve stimulation (PNS) for chronic shoulder pain
at the end of treatment and up to six months from the start of
treatment has been published in Pain Management. “Real-world
evidence of durable multi-dimensional improvement after 60-day PNS
treatment used for shoulder pain” analyzes four domains of health
(pain, quality of life, physical function, and sleep) reflecting a
more holistic approach evaluating the impact of pain treatment for
patients in everyday use. Responders were defined as patients that
reported at least 50 percent pain relief for the pain domain, and
patients indicating improvement (Patient Global Impression of
Change greater than or equal to one) were considered responders in
the quality-of-life, physical function, and sleep measurements.
- Rate of Responders: 80.7 percent of patients
(n=620/768) responded in at least one domain at the end of
treatment.
- Holistic Responders: 45.8 percent (n=352/768)
of patients were defined as holistic responders, responding in all
four domains.
- Sustained Response: Among a subset of
responders at end of treatment with available follow-up, a
cumulative 75 percent continued to respond at six months. Response
rates were 85 percent (n=140/165) at three months and 88 percent
(n=53/60) at six months.
This real-world analysis included patients who were
treated for chronic shoulder pain and opted-in to provide
information to the device manufacturer. Patients received one or
two leads to deliver PNS treatment, most commonly targeting the
suprascapular nerve and the axillary nerve, either at the deltoid
or the quadrangular space. The study’s lead author was Dr. Ali
Valimahomed, MD, FAAPMR, of the Advanced Orthopedics and Sports
Medicine Institute and SPR consultant.
“Chronic shoulder pain is common, but patients
suffering with it often find limited treatment options,” said Maria
Bennett, President, CEO, and Founder of SPR® Therapeutics.
“Patients may view surgical interventions as a last resort, but
less invasive treatments may not do enough to relieve pain. The
SPRINT PNS System is used for 60 days and presents a clinically
proven, non-opioid, and non-surgical option for patients.”
Among the patients included in the analysis, no
serious adverse events were reported. The most common event was
skin irritation, reported by 3.3 percent (n=25) of patients.
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 McDonald
Vice President – Marketing
mmcdonald@sprtherapeutics.com
844.378.9108
Dave Folkens
Public Relations
dfolkens@sprtherapeutics.com
612.978.6547