Enovis Introduces Manafuse Bone Growth Stimulator

Enovis Corporation has launched the Manafuse Bone Growth Stimulator, a portable, battery-powered medical device indicated for daily use to noninvasively treat indicated fresh fractures and fracture nonunion.

The stimulator emits a Low Intensity Pulsed Ultrasound (LIPUS) signal that helps activate the body’s natural healing process. Backed by 30 years of clinical evidence, LIPUS technology has been shown to offer statistically significant improvement in fracture healing when used as indicated.^1,2,3

Clinical studies reported success rates as high as 86% for nonunions.³ In one prospective, randomized, double-blind, placebo-controlled study of 67 fresh tibial fractures, LIPUS treatment accelerated healing by 38%—a difference of more than eight weeks.¹

The Manafuse Bone Growth Stimulator is designed to be used for 20 minutes once a day for up to 343 days. Lightweight, comfortable and easy to use with one-touch operation, the device also tracks daily treatment compliance.

“The Manafuse Bone Growth Stimulator, powered by noninvasive LIPUS technology, delivers meaningful benefits to patients with difficult-to-heal fractures,” Enovis Regeneration President Brad Batte said. “LIPUS is a powerful complement to our CMF bone stimulation devices, giving physicians the flexibility to choose the most effective solution for each unique fracture case. With robust clinical evidence and two of the lowest daily wear times available, both LIPUS and CMF devices enable faster, more comfortable healing for patients. Enovis now offers one of the most comprehensive and clinically validated portfolios in regenerative technologies for fracture healing—backed by science and built for improved outcomes.”

The Enovis regeneration device portfolio also includes the noninvasive OL1000 and Spinalogic Bone Growth Stimulators. Portable and battery-powered, these medical devices use low-strength Combined Magnetic Field (CMF) technology to help heal established nonunion fractures with 30 minutes of daily treatment and can be worn over a cast, brace or clothing. Clinical studies reported success rates as high as 89%.⁴ The Spinalogic device, indicated as an adjunct electromagnetic treatment to primary lumbar spinal fusion surgery for one or two levels, has shown a 21% increase in primary lumbar fusions over a placebo device.⁵

Enovis Corporation is a medical technology growth company developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. The company’s range of products, services, and integrated technologies fuels active lifestyles in orthopedics and beyond.

References
¹ Heckman JD, Ryaby JP, McCabe J, Frey J, Kilcoyne RF. Acceleration of tibial fracture-healing by non-invasive, low-intensity pulsed ultrasound. J Bone Joint Surg Am. 1994;76(1):26-34. doi:10.2106/00004623-199401000-00004
² Kristiansen TK, Ryaby JP, McCabe J, Frey JJ, Roe LR. Accelerated healing of distal radial fractures with the use of specific, low-intensity ultrasound. A multicenter, prospective, randomized, double-blind, placebo-controlled study. J Bone Joint Surg Am. 1997;79(7):961-73. doi:10.2106/00004623-199707000-00002
³ Nolte PA, van der Krans A, Patka P, Janssen IM, Ryaby JP, Albers GH. Low-intensity pulsed ultrasound in the treatment of nonunions. J Trauma. 2001;51(4):693-703. doi:10.1097/00005373-200110000-00012
⁴ P910066 / S005] Phillips, Mark, et al. “Use of Combined Magnetic Field Treatment for Fracture Nonunion.” Journal of Long-Term Effects of Medical Implants 26.3 (2016).
⁵ Linovitz R, Pathria M, Bernhardt M, et al. Combined Magnetic Fields Accelerate and Increase Spine Fusion: A Double-Blind, Randomized, Placebo Controlled Study, Spine. 2002 July; 27(13):1383-1388.