Micron Medical Receives FDA 510(k) Clearance for MOVENTIS PNS, a Drug-Free Wireless Peripheral Nerve Stimulator System for Common Urological Conditions; Commercial Launch Underway
BOCA RATON, Fla., Sept. 14, 2020 (GLOBE NEWSWIRE) -- Micron Medical, a privately-held medical device company engaged in the development, manufacture and commercialization of innovative wireless, minimally invasive, electroceutical device solutions for urological conditions, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for MOVENTIS PNS, a percutaneous implantable pulse generator (pIPG) nerve stimulator system to treat chronic peripheral nerve pain that has therapeutic effects for common urological conditions involving pelvic pain. The Company has already commenced a limited U.S. commercial launch of the product. In addition, Micron has submitted a De Novo 510(k) application for PROTECT PNS in the significant market indication of overactive bladder (OAB).
The Micron device, at only 7 cm long, is smaller than any PNS implant currently available on the market today, at a volume of only 0.10 cc. Moreover, it provides power levels up to 23.3 mA, which is also more powerful than any other currently available PNS device. The small size and significant power is designed for the rugged tissue impedance needs of peripheral tissue mediums to ensure that long-lasting and continuous therapy will be delivered.
“The FDA’s 510(k) clearance of Moventis PNS, along with the PROTECT PNS De Novo submission application, provide the potential for Micron to offer an unmatched neuromodulation product offering to the urology community in 2021. We are delighted to be able to bring a new, minimally invasive treatment option to patients who suffer from debilitating peripheral origin pelvic pain as a result of common, yet significant, urological conditions,” said Laura Perryman, co-Founder and President of Micron Medical. “In addition, our submission of the De Novo application for PROTECT PNS, a wireless, minimally invasive, electroceutical device solution for the treatment of OAB, a condition that affects over 37 million Americans1 and represents a multi-billion dollar market opportunity, is a key regulatory milestone for Micron.”
“The MOVENTIS PNS FDA clearance allows Micron to evolve from a development-stage medical device company to a commercial organization with a significant opportunity to treat thousands of patients each year who suffer from pelvic pain,” said Matt Kemp, Chief Commercial Officer of Micron Medical. “We have already begun a limited commercial rollout of this exciting product and expect that it will be well-received by the urologic market. In OAB, if our PROTECT PNS receives FDA classification, we will be targeting a large market with established reimbursement with device-specific coding granted by the American Medical Association.”
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1 Irwin_DE, Kopp_ZS, Agatep_B, Milsom_I, Abrams_P. Worldwide prevalence estimates of lower urinary tract symptoms, overactive bladder, urinary incontinence and bladder outlet obstruction. BJU International 2011;108(7):1132-8.
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