Clinical Overview

Leading Edge Technology


SofPulse is an easy-to-place, non-invasive device that delivers targeted pulsed electromagnetic field therapy to enhance post-surgical recovery, naturally. tPEMF is an innovative process that uses proprietary technology to reduce pain, swelling and inflammation. The therapy is non-invasive and non-pharmacologic, with no known side effects and no potential for overdose or dependency. SofPulse has been
used effectively and studied extensively in soft tissue postoperative management.

Recommendations for Use​

 

tPEMF therapy is recommended for a variety of health conditions, below are just a few of the uses for this innovative technology.

  • Post-surgical and chronic pain

  • Inflammation and edema

  • Acute and chronic wounds

  • Neuropathy

  • Orthopedic conditions

  • Osteoarthritis

  • To promote vasodilation and angiogenesis

No Contraindications

SofPulse has no contraindications. The FDA label has indicated use, warnings and precautions (each is of a lesser concern down to precautions)

  • Indications:  Adjunctive use in the palliative treatment of postoperative pain and edema in the superficial soft tissue. SofPulse is not indicated as a substitute for treatment of deep tissues such as internal organs. 

  • Warnings: Be sure to ask the patient about possible implants before deciding to use SofPulse. If the patient has implanted leads or an implant containing lead, tPEMF therapy should not be used, even if the implant has been turned off. Examples of implanted systems that may contain lead include cardiac pacemakers and defibrillators, cochlear implants, bone growth stimulators, deep brain stimulators, spinal cord stimulators, and other nerve stimulators. 

  • Precautions: Should not be used during pregnancy or over the joints of skeletally immature patients. The long-term biological effects of pulsed electromagnetic energy are not known at this time.

Clinician Frequently Asked Questions

How does SofPulse targeted Pulsed Electromagnetic Field (tPEMF) therapy work?


By emitting electric pulses, the Endonovo tPEMF products create an electromagnetic field which evenly penetrate both soft and hard body tissue around the target area. This electromagnetic field causes a chemical cascade, which activates the Nitric Oxide cycle. Nitric Oxide is a key molecule in healing. The compound is released when we exercise, and when we are injured, for the body to naturally repair itself. This natural process allows patients to get back to life faster with less use of narcotics.

tPEMF increases Nitric Oxide production to help speed healing of soft and hard tissues--that includes skin, tendons, ligaments, bones and organs. The specific ratio of frequency to burst width used by the device has been found to be the most effective at delivering the amount of current that is like what is already used by the body. More is not always better, and too much Nitric Oxide production can slow healing. When choosing a tPEMF device, it is good to know that more power is not correlated with faster healing.

In general, tPEMF can be used to speed healing, reduce inflammation, and lower pain levels. For any kind of orthopedic injury or surgery, the tPEMF device is a great tool to use in the recovery stage. The field penetrates clothing, bandages, and casts to reach all the tissue in the target area.




What are the indications for use for SofPulse?


SofPulse is FDA approved for post-surgical pain and swelling and CMS reimbursed for wound healing.

According to NPUAP and EPUAP (2016 Guidelines): Consider the use of pulsed electromagnetic field (PEMF) treatment for recalcitrant Category/Stage II pressure injuries as well as any Category/Stage III and IV pressure injury (http://www.npuap.org/wp-content/uploads/2014/08/UPDATED-Quick-Reference-Guide-DIGITAL-NPUAP-EPUAP-PPPIA-Oct2014.pdf)

American Society of Aesthetic Plastic Surgeons endorses use of tPEMF (2001)
post-operatively.




Are there any side-effects of tPEMF therapy?


Unlike prescription drugs or narcotic painkillers, no side effects have been reported with the use of tPEMF therapy. Since tPEMF therapy increases circulation, while not likely, some patients may feel a subtle warming or tingling sensation.

Narcotic painkillers and prescription anti-inflammatory medications can result in vomiting, diarrhea, dehydration, bleeding of the stomach, severe drowsiness, constipation, and many other adverse side effects. With all treatments performed to date, there are no adverse events. And because SofPulse minimizes the requirement for prescription medication, there are reduced risks of addiction or overdose.

With tPEMF therapy, the body does not respond to the low energy signal unless there is inflamed tissue so there is no risk of overdose.




What are the contraindications for tPEMF therapy?


Endonovo tPEMF products have no contraindications. The FDA label has indicated use, warnings and precautions (each is of a lesser concern down to precautions)

Indications: Adjunctive use in the palliative treatment of postoperative pain and edema in the superficial soft tissue. tPEMF is not indicated as a substitute for treatment of deep tissues such as internal organs.

Warnings: Be sure to ask the patient about possible implants before deciding to use tPEMF. If the patient has implanted leads or an implant containing lead, tPEMF therapy should not be used, even if the implant has been turned off. Examples of implanted systems that may contain lead include cardiac pacemakers and defibrillators, cochlear implants, bone growth stimulators, deep brain stimulators, spinal cord stimulators, and other nerve stimulators. Precautions: Should not be used during pregnancy or over the joints of skeletally immature patients. The long-term biological effects of pulsed electromagnetic energy are not known at this time.




What type of tPEMF therapy should I recommend for my patient?


There are three products in our tPEMF product line: SofPulse, WoundPulse and OrthoHalo. You can select the product that will help you to achieve your patient care goals. All of our tPEMF devices are portable, easy to use and can be used in your healthcare facility and in the home environment.

We offer two settings for your device. One is an auto setting and the other is manual. We recommend that you use the Endonovo tPEMF for 15 minutes at a time. The device will shut off after 15 minutes- regardless of which mode you are using. The timer will not need to be set and the device will automatically turn off after the treatment is completed.

The primary difference between the settings is that with the manual setting you will need to remember to turn the device on for therapy while the auto setting provides treatment on a pre-programmed cycle.




How soon will I see results?


For acute inflammation, you should see noticeable relief after the first or second treatment. With chronic or degenerative issues, you may not see notable results for two to four weeks. Treatments should be continued as recommended for long-term healing.





 
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Contact Us:  info@sofpulse.com

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The information included in this web site has been prepared for and is intended for viewing by residents of the United States of America. This web site contains information about products which may or may not be available in different countries and if applicable, may or may not have received approval or market clearance by a governmental regulatory body for different indications for use. Please contact us regarding the purchase or sale of SofPulse in other countries.