About tPEMF Technology

Targeted pulsed electromagnetic fields (tPEMF)
are simply delivery systems for inducing electromagentic currents. Pulsing an electromagnetic field near a conductor (such as tissue) will induce current flow in the conductor.

tPEMF transmits gentle pulses of therapy into tissues and cells to deliver a therapeutic electronic field to injured tissues This electric field helps activate the body’s natural anti-inflammatory response to injured tissue. The electric fields transmitted into tissues and cells are gentle and safe – Enonovo's tPEMF products emit a pulsed electromagnetic field that has 1,000 times LESS power than your mobile phone.

Simply put, tPEMF uses targeted electromagnetic fields to transmit gentle pulses to the tissue to help reduce pain and swelling and speed up the body's natural recovery process.

 

Mechanism of Action

Right down to the cellular level, the body works on an electro-chemical basis. In fact, all activity in the body is caused or facilitated by electrically driven binding processes. tPEMF has been shown in multiple publications to affect the electro-chemical process that triggers the release of nitric oxide — the first step in the body’s natural
anti-inflammatory response.

  • tPEMF is placed on the desired treatment area (treatment depth is
    5” and works through dressings, casts and clothing)

  • The body responds within milliseconds by releasing nitric oxide, the
    body’s own natural anti-inflammatory chemical.

  • The blood vessels respond by smoothing out and allowing greater blood flow. 
    This reduces pain and edema.

  • Downstream growth factors are released (hours to days)

  • Angiogenesis occurs (days to weeks)

Regulatory Approvals and Industry Guidelines

Regulatory Approvals

  • FDA Cleared for treating post-operative pain and edema in soft tissue

  • CE mark for the treatment of pain, wounds and edema (Class 2a)

  • CMS national coverage determination for PEMF for chronic wounds

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

  • Rated as comparable to NPWT (in relation to clinical evidence)

  • The body does not respond to the low energy signal unless there is inflamed tissue so there is no danger of overdose

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

Frequently Asked Questions

For Clinicians

How does the targeted Pulsed Electromagnetic Field 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 the body is already using. 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?


SofPulse can help you to achieve your patient care goals. Our tPEMF devices are portable, easy to use and can be used in your healthcare facility and in the home environment.

SofPulse offers 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.





For Patients

Will I feel anything during my SofPulse treatment?


The Endonovo tPEMF products can markedly increase blood flow and tissue oxygenation, which improves the overall tissue health and reduces pain associated with lack of sufficient oxygen. We often hear reports from clinicians that their patients relax as soon as they start their treatments with the tPEMF. With the many healing benefits that the tPEMF offers, this is not surprising.




How do I use the SofPulse tPEMF?


It is always best to refer to our Clinical Use Guide or Patient Use Guide before beginning treatment. SofPulse can be used through clothing, dressings and casts. It is recommended that the device be removed before showering/bathing.

Treatment will vary by injury, seriousness of the injury and whether the device is being used for condition is chronic or degenerative conditions. Treatments are 15 minutes and the number of times per day will vary by condition.

In general, we recommend that you start with a loading dose of two to four 15-minute treatments per day for acute and chronic or degenerative conditions.

For acute conditions (such as post-surgical treatment or recovery from a trauma), we recommend that you continue two to four treatments per day for the first week or so and then taper off for the next seven to 10 days or until the condition is fully healed.

For chronic or degenerative conditions, we recommend that you continue with two to four treatments per day for two to four weeks and monitor the patient until you see improved mobility and less pain response. Again, you can taper down to one or two treatments per day or even one to three treatments per week.

Ultimately, you want to consider that the SofPulse is catalyzing the anti-inflammatory cascade as well as accelerating the body’s own healing properties. We rely on physicians to assess the patient and to work with the pet owner on the best treatment protocols for each case.




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.




How do I get the tPEMF?


tPEMF is prescribed by prescription only. There are two ways to purchase the SofPulse tPEMF: 1) get one from your physician, or 2) purchase one direct from Endonovo with a prescription from your physician.




Why do I need to talk to a physician to get a SofPulse tPEMF device?


Physicians can determine the severity of an issue and are generally able to pinpoint the specific area in the body that needs treatment. They work with the patient directly and advise them on the most effective treatment plans. Often the SofPulse is a part of an integrated multi-modality treatment plan. Patients benefit from visiting their physicians on a regular basis, getting assessments on their progress and up-to-date advice on continued treatment with the SofPulse device.




Why can't I replace or recharge the tPEMF's battery?


There is a medical and a regulatory basis for the tPEMF products sealed case. As a condition for clearing the tPEMF as a medical device, the FDA required that it be able to deliver its patented, therapeutic waveform consistently over its entire design life of the product. Sealing all operating components inside the case—the applicator connections to the circuit board, signal generator, microprocessor, power supply and the battery—provided the FDA with the required assurance of signal integrity. Breaking the case seal for any reason renders the device non-compliant with the conditions of its 510(k) clearance.





 
Endonovo Therapeutics logo

Contact Us:  info@sofpulse.com

Copyright 2018-2019 Endonovo Therapeutics, Inc.
All Rights Reserved | Sitemap | www.endonovo.com

  • Facebook Social Icon
  • Twitter Social Icon
  • YouTube Social  Icon

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.