Moventis PNS Drug-Free Neuromodulation Knee Pain Relief FLEX Study Commences Enrollment at Sites Nationwide
Moventis PNS, the smallest and most powerful IPG is available nationwide commercially through authorized agents only
BOCA RATON, FL / ACCESSWIRE / July 22, 2021 / Moventis PNS, part of Pain Specialists Group Ltd, marketing the drug free pain treatment device nationwide for peripheral nerve pain, today announced enrollment and implant commencement of a new randomized clinical trial treating painful knee pain, the “FLEX” study.
“Moventis PNS is the most powerful neurostimulation device ever available, designed exclusively for peripheral pain with on-demand paresthesia, or optional sub-threshold pre-programmed settings, guaranteed for 10+ year life. Unlike other options that just re-purpose spinal cord stimulators, Moventis PNS technology takes the complexity and guess work out – and provides tele-health options to enable a new generation of patients to benefit from our micro-sized, 0.10 cc innovative implantable pulse generator (pIPG) solution,” said Ms. Andrea Berry, Vice President of Client Experiences for Moventis PNS.
More than 30 million Americans- one out of every ten adults – live with some level of chronic knee pain. Nerve stimulation is a well-established treatment, however traditional equipment has under served most of the patient population. The FLEX study is an FDA IDE approved study to investigate Moventis PNS, at just 7 cm in length, and up to 24 mA of output power, as a safe and effective tool for up to 300 subjects who will be enrolled in the study.
“Peripheral neuromodulation is an important up and coming tool in improving treatments for peripheral limb pain. The field of pain management stands to benefit from Moventis PNS clinical research with the FLEX Study for treating chronic knee pain,” said Anne Christopher, MD, a study investigator at St. Louis Pain Consultants.
This study will focus on comparing the commercially available PNS therapy versus sham (device off state) in a prospective, randomized controlled trial over 36 months in 300 subjects. The study will take place at over 30 sites throughout the US in conjunction with pain treatment diagnostic testing centers.
“Treating patients with chronic, centralized pain can be very challenging. Commonly, many are treated with pharmaceutical medication which has led to an epidemic of addiction. For those challenging patients, I have successfully used the minimally invasive peripheral nerve stimulator from Moventis PNS,” said Dr. Leonard Talrico, of the Foot and Ankle Center, Georgia. “This device offers on-demand pain relief when the patient needs it. Virtually all of my patients have discontinued or significantly reduced their pain medications following implantation and they have been allowed to return to more active lifestyle. This device not only offers an alternative to pharmaceuticals, but may very well become the standard of care for the hard to treat chronic pain patients.”
Moventis is currently supported by over 50 agents nationwide, and the team will be expanding to over 100 by the end of 2021 to educate the pain community on the advantages of incorporating Moventis PNS into their practice to offer a drug-free, less invasive option to their patients.
To learn more about participating in the FLEX chronic knee pain study and connecting with an AUTHORIZED agent*, please see www.moventispns.com.
*Moventis PNS inventory may be attempted to be distributed by 3rd parties that are not sanctioned or authorized to distribute product or participate in the study, including Miami MedTech, Stimwave Technologies, and Therapeutic Holdings.
About Moventis PNS
Moventis PNS is owned by Pain Specialists Group Ltd and distributed by Micron Medical Corporation, providing patients with a convenient, safe, minimally invasive, and highly cost-effective pain management solutions easily incorporated into their daily lives. The Moventis PNS system is the world’s smallest and most powerful peripheral nerve stimulator to treat chronic pain of the back, hip, knee, shoulder, abdomen, leg, arm, wrist, neck, foot, and ankle. Moventis PNS is an FDA Cleared system, with implantable device life of 10 years+ and commercially available in the US. Learn more about Moventis PNS and the clinical research at www.moventispns.com
SOURCE: Micron Devices
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