FAQs - Manafuse

Starting a new therapy can bring up a lot of questions and that’s completely normal. The Manafuse™ Bone Growth Stimulator is designed to support your body’s natural healing process, and this FAQ page is here to help you understand exactly what that means. Below you’ll find straightforward answers about how the device works, how to use it day‑to‑day, what you can expect from treatment, and where to get help if you need it.

Our goal is to make your healing journey as smooth and stress‑free as possible. If you’re just getting started or simply looking for clarity along the way, you’ll find the guidance you need right here. If you do have any questions, please reach out to your sales representative or our customer care team at bonestim@enovis.com or call 800.263.6004.

How Does it work?

The Manafuse™ bone growth stimulator is a nonsurgical treatment prescribed by your physician to help heal your bone fracture. The stimulator emits a Low Intensity Pulsed Ultrasound Stimulation (LIPUS) that, when placed directly on the skin over your bone fracture, assists in activating the body’s natural healing process. As reported in published data, Manafuse LIPUS technology offers statistically significant improvement in fracture healing when used as indicated.

If your fracture has been immobilized with a cast, you may require a window in your cast to properly apply the Manafuse treatment. Your device includes a strap to assist in keeping the transducer head comfortably and appropriately placed on the skin directly over your fracture. The strap and lightweight nature of the design allow you to perform daily activities while undergoing treatment but always check with your physician before performing activity while treating. You should not feel Manafuse LIPUS therapy during your treatment.

It is very important that you use your Manafuse device daily as prescribed. The Manafuse device will allow you to treat your fracture for 20 minutes per day for up to 343 days. While you have the flexibility to treat at any time you choose, it is recommended that you perform treatment at approximately the same time each day. Your device will track your daily treatment and your doctor may ask you to bring the device to your follow-up visits to check your usage history.

Your doctor will closely monitor your progress and will let you know when you no longer need to use your Manafuse device. Typically, treatment is continued until your fracture has healed. Once you have completed your treatment, you may choose to keep the device or return it to Enovis for recycling or proper disposal. Manafuse is a single-patient use device and may not be passed to other patients.

Are there known side effects of Lipus?

There are no known side effects related to the use of this device. Thousands of patients have been prescribed Low Intensity Pulsed Ultrasound to help heal their fractures. Please refer to your package insert to review additional information about your prescribed device.

Can I wear the Manafuse if I am pregnant?

The safety of the Manafuse is not known if you are pregnant or nursing. Therefore, if you are pregnant or nursing, you should consult your doctor before using the Manafuse.

Can I use the Manafuse if I have a pacemaker?

The operation of active, implantable devices, such as cardiac pacemakers, may be adversely affected by close exposure to the Manafuse device. Your physician should advise you or anyone who would be near you during treatment to be evaluated by their attending cardiologist or implant physician before starting treatment with the Manafuse device.

How effective is the Manafuse lipus technology?

In a prospective, randomized, double-blind, placebo-controlled study of 67 tibial fresh fractures, LIPUS treatment accelerated healing by 38% - a difference of more than 8 weeks.¹

In a prospective, randomized, double-blind, placebo- controlled study of 61 distal radius fractures, LIPUS treatment accelerated healing by 38%.²

A study of Low-Intensity Pulsed Ultrasound for the treatment of nonunion fractures reported an 86% heal rate with an average healing time of 5 months. The average age of the fracture at the initiation of treatment was 14.3 months.³

Individual patient results may vary.

USE

Can I travel with my Manafuse?

Yes. Although not commonly required, before you travel you may request a letter from our Customer Service Support department or your Enovis™ Sales Representative that will explain what the device is and how it operates. You can also keep your user manual available to quickly and easily identify the device for any security personnel.

How often will I need to charge my Manafuse?

A fully charged battery should last for 10 hours. You should fully charge your Manafuse device prior to your initial use. A charging cable is provided with your device. The Micro- USB plug end of the charger cord plugs into the bottom of the device. The other end plugs into the adapter, which plugs into a wall outlet. The charger requires a standard US 120 VAC, 60Hz, household electrical outlet. A “low battery” symbol will appear on the LCD screen on your remote indicating that the battery needs to be charged.

What do I do with the device when I am finished using it?

After your treatment is complete and your doctor says you no longer need to use your Manafuse, you may dispose of the device yourself according to your local governing ordinances and recycling plans. You may also contact our Customer Support department (800.263.6004) for help with device disposal. The Manafuse is not reusable. Each device is for single-patient use only and cannot be re-sold or used on multiple patients.

INSURANCE

Will my insurance pay for the device?

Insurance policies are different depending on the plan you have. The Manafuse™ bone growth stimulator is covered by the majority of health plans including Medicare and workers compensation plans; specific coverage criteria must be met.

Does Enovis preauthorize the device with my insurance company?

If pre-authorization is required, Enovis™ will verify your eligibility and benefit levels to obtain a pre-authorization from the payer of record.

What happens if my insurance company denies the claim?

In the event the insurance carrier denies coverage, the claim will be forwarded to our appeals processing department on your behalf. Depending upon the outcome, Enovis™ may contact you to arrange payment options.

Ryaby, J.T., et al., The Role of Insulin-like Growth Factor in Magnetic Field Regulation of Bone Formation, Bioelectrochemistry and Bioenergetics, 35: 87-91, 1994
Fitzsimmons RJ, Ryaby JT, Magee FP, Baylink DJ. IGF-II receptor number is increased in TE-85 osteosarcoma cells by combined magnetic fields. J Bone Miner Res. 1995 May;10(5):812-9.
Charles Sfeir, DDS, PhD, Lawrence Ho, Bruce A. Doll, DDS, PhD, Kodi Azari, MD, and Jeffrey O. Hollinger, DDS, PhD. Fractrue Repair. Bone Regeneration and Repair, Biology and Clinical Applications. 2005, XII, 398p
Raiszadeh, Ramin, et al. "Effectiveness of combined magnetic field bone growth stimulation on lumbar spinal fusion outcomes: a single center retrospective analysis comparing combined magnetic field to no-stimulation." International Journal of Research in Orthopaedics 6.3 (2020): 1. A retrospective study that utilized radiographic fusion criteria, included data from 4 surgeons, consisted of a heterogenous patient population and had minimum 6 months follow up.
Wu N, Lee YC, Segina D, Murray H, Wilcox T, Boulanger L. The economic impact of US patients With fracture non-union, Orthopedic Research and Reviews, 2013; 5:21–33
[PMA 910066] Phillips, Mark, et al. "The Use of Combined Magnetic Field Treatment for Fracture Nonunion: A Prospective Observational Study." Journal of Long-Term Effects of Medical Implants 26.3 (2016).
NASS coverage reccomendations: https://www.spine.org/coverage
Linovitz, Raymond J., et al. "Combined magnetic fields accelerate and increase spine fusion: a double-blind, randomized, placebo controlled study." Spine 27.13 (2002): 1383-1388.
Mcleod, Kenneth J., and C. T. Rubin. "The effect of low-frequency electrical fields on osteogenesis." J Bone Joint Surg Am 74.6 (1992): 920-9.
[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).
Joel Russell, Sheila Sprague, Sam Harper, Michelle Green & Mohit Bhandari (2021) An early cost analysis of magnetic bone growth stimulation in England, Expert Review of Pharmacoeconomics & Outcomes Research, DOI: 10.1080/14737167.2021.1920402
Fitzsimmons RJ, Ryaby JT, Magee FP, Baylink DJ. Combined magnetic fields increased net calcium flux in bone cells. Calcified Tissue International. 1994;55(5):376-380. doi:10.1007/bf00299318
Aleem IS, Aleem I, Evaniew N, et al. Efficacy of electrical stimulators for Bone Healing: A meta-analysis of randomized sham-controlled trials. Scientific Reports. 2016;6(1). doi:10.1038/srep31724
Patient IFU Fracture
Cottrill E, Pennington Z, Ahmed AK, et al. The effect of electrical stimulation therapies on Spinal Fusion: A cross-disciplinary systematic review and meta-analysis of the preclinical and Clinical Data. Journal of Neurosurgery: Spine. 2019;32(1):106-126. doi:10.3171/2019.5.spine19465
Rami E, Rae S, John A. Increased spinal lumbar fusion with combined magnetic field (CMF) bone growth stimulation. Journal of Orthopedic Surgery and Techniques. 2020;3(1). doi:10.36959/453/526
Stippick TW, Sheller MR. Combined magnetic fields provide robust coverage for interbody and posterolateral lumbar spinal fusion sites. Medical & Biological Engineering & Computing. 2015;54(1):113-122. doi:10.1007/s11517-015-1319-2
Patient IFU Spine
Baumhauer Phillips M, Baumhauer J, Sprague S, Zoltan J. Use of Combined Magnetic Field Treatment for Fracture Nonunion. J Long Term Eff Med Implants. 2016;26(3):277-284. doi: 10.1615/JLongTermEffMedImplants.2016016818. PMID: 28134611.
Enovis™ CMF PMA: P910066/S005, May 1997
“Tough/Difficult fracture” defined per the following: Success rates obtained on fractures greater than 9 months post-injury; Mean time since initial injury = 29.3 months; Mean number of prior surgeries = 2.5.
Elsabeh R, Stegall R, Abrahams J (2020) Increased Spinal Lumbar Fusion with Combined Magnetic Field (CMF) Bone Growth Stimulation. J Orthop Surg Tech 3(1):84-91.
PMA P210016 1/17/2025
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
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
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
OL1000 PMA 910066
https://www.spine.org/coverage
The only technology approved and with clinical evidence at 30 minutes per day.
Goodwin CB, Brighton CT, Guyer RD, Johnson JR, Light KI, Yuan HA. A double-blind study of capacitively coupled electrical stimulation as an adjunct to lumbar spinal fusions. Spine. 1999;24(13):1349-1356.
PMA P850007/S6. February 1990 and Jenis, Louis G., et al. "Prospective comparison of the effect of direct current electrical stimulation and pulsed electromagnetic fields on instrumented posterolateral lumbar arthrodesis." Clinical Spine Surgery 13.4 (2000): 290-296.
Cook SD, Ryaby JP, McCabe J, Frey JJ, Heckman JD, Kristiansen TK. Acceleration of tibia and distal radius fracture healing in patients who smoke. Clin Orthop Relat Res. 1997;(337):198-207. doi:10.1097/00003086-199704000-00022 (need to get paper to determine if these were within 0-7 days)
Zura R, Mehta S, Della Rocca GJ, Jones J, Steen RG. A cohort study of 4,190 patients treated with low-intensity pulsed ultrasound (LIPUS): findings in the elderly versus all patients. BMC Musculoskelet Disord. 2015;16:45. (Fresh and Intermediate <90 days is fresh, 0-90 days)
Nolte P, Anderson R, Strauss E, et al. Heal rate of metatarsal fractures: a propensity matching study of patients treated with low-intensity pulsed ultrasound (LIPUS) vs. surgical and other treatments. Injury. 2016;47(11):2584-90. doi:10.1016/j.injury.2016.09.023
Gebauer D, Mayr E, Orthner E, Ryaby JP. Low-intensity pulsed ultrasound: effects on nonunions. Ultrasound Med Biol. 2005;31(10):1391-402. doi:10.1016/j.ultrasmedbio.2005.06.002
Lerner A, Stein H, Soudry M. Compound high-energy limb fractures with delayed union: our experience with adjuvant ultrasound stimulation (exogen). Ultrasonics. 2004;42(1-9):915-7. doi:10.1016/j.ultras.2003.11.014
Schofer MD, Block JE, Aigner J, Schmelz A. Improved healing response in delayed unions of the tibia with low-intensity pulsed ultrasound: results of a randomized sham-controlled trial. BMC Musculoskelet Disord. 2010;11:229. doi:10.1186/1471-2474-11-229

*This patient’s statement relates an account of their response to treatment. This account is genuine, typical and documented. However, this response does not provide any indication, guide, warranty or guarantee as to the response other people may have to the treatment. The response other individuals have to the treatment could be different. Responses to the treatment can and do vary. Not every response is the same.

Browse Products by: