Revitive Overview & Clincial Evidence

FDA-Cleared, Medical Device Designed to Temporarily Reduce Leg Pain & Swelling

Revitive Circulation Boosterâ is an FDA-cleared medical device indicated as an adjunctive treatment to temporarily reduce lower extremity pain, swelling, and cramping in patients with conditions or diseases associated with poor blood flow in the legs and feet. Revitive is also indicated to increase blood circulation in leg muscles.1

Revitive uses Neuromuscular Electrical Stimulation (NMES) technology to deliver electrical impulses to leg muscles through the feet. The NMES causes muscles in the calf and foot to contract, which leads to increased circulation and relieved pain in lower legs during use. Revitive comes with an IsoRocker that rocks feet back and forth to allow for natural ankle movement and increased circulation in the lower legs.1

The NMES technology has been shown to significantly improve swelling and pain,5-7 as well as increase arterial and venous blood flow in several clinical trials.2,5-7 Revitive is clinically proven to increase leg blood flow in both healthy people and people with conditions or diseases associated with poor blood flow in the legs and feet during use.2-4


Clinical Study in Healthy Individuals 

Significantly increased arterial and venous blood flow during use2

In a pilot study, 30 healthy individuals with no known underlying conditions used Revitive for 30 minutes.2

Compared with blood flow and time averaged mean velocity (TAMV) at baseline, Revitive use at 15 minutes resulted in:2

  • Significant increase in median venous blood flow by 88 cc/min (31%, p = .014) and increase in TAMV by 1.1 cm/s (38%, p = .065).
  • Significant increases in median arterial blood flow by 39 cc/min (53%, p < .0001) and TAMV by 2.2 cm/s (62%, p = .0003).

Ultrasound hemodynamic results with Revitive

TAMV=time averaged mean velocity, *p < .05, **p < .001.

Revitive was reported to be safe and well-tolerated.2


Clinical Study in Peripheral Artery Disease (PAD)

Studied as an adjunctive therapy in a randomized controlled trial3

In a study by Babber et al, patients with intermittent claudication (IC) who were able to complete a supervised exercise program (SEP) were randomized to either the SEP only group or the SEP with Revitive (NMES) group. Patients in the SEP/Revitive group received a brief induction and training with the Revitive device. These patients were instructed to use the device at home for minimal of 30 minutes daily for a total of 6 weeks. A total of 37 patients (20 in the SEP group and 17 in the SEP/Revitive group) completed the study.3

Combination of Revitive and SEP significantly improved walking distances, blood flow, and quality of life at 6 weeks3

Compared with Supervised Exercise Program (SEP) alone, the combination of Revitive and SEP resulted in:3

46% greater walking distance at week 6 as measured by the initial claudication distance (ICD) (p = .014 

  • Significantly greater change in ICD over 6 weeks (Revitive/SEP: 40.4 m, SEP only: 7.5 m, p = .012)

Change in Initial Claudication Distance (ICD) over 6 Weeks in SEP Only vs. Revitive/SEP Groups

Individual and median (IQR) values are shown. *P<0.050.

  • Blood volume flow and time-adjusted mean velocity increased significantly with the device on (P<0⋅050).
  • Significant improvement in the Intermittent Claudication Questionnaire score change (Revitive/SEP: -11.2 vs. SEP only: -4.2, p = .037)

Change in Disease-Specific Intermittent Claudication Questionnaire Scores Over 6 Weeks in SEP Only and Revitive/SEP Groups

High adherence rate3

Revitive achieved 96% adherence rate among patients who completed the study (n=17) with good tolerance of device use.3


Clinical Study in Chronic Venous Disease (CVD)

Revitive was studied in a pilot randomized controlled trial with 22 patients who were diagnosed with superficial and/or deep venous disease with Clinical Etiological Anatomical and Pathophysiological (CEAP) clinical class C2–C4. Patients were randomized in a 1:1 ratio to the Revitive (NMES) group or the sham device group.4

Patients in the Revitive group were advised to use Revitive at the highest intensity comfortable for them for 30 minutes daily for 6 weeks. Patients in the sham group received a device identical to the test device but without electrical impulses. These patients were instructed to place their feet on the sham device, simulating the effect of sitting still for 30 minutes.4

Baseline Characteristics

No significant between-group differences in CEAP classification and the use of compression stockings.4

There were significant between-group differences in patient’s age and BMI, primarily due to the small sample size. A larger RCT trial has been completed demonstrating similar benefit in using Revitive, this will be publish later this year.

Baseline Patient Characteristics

One patient in the test group withdrew after 3 weeks due to ruptured Baker’s cyst not connected with Revitive use.

Significantly improved venous flow parameters during and after device use4

Compared with patients in the sham group, patients in the Revitive group had:4

  • Significantly higher improvement in time-averaged mean velocity (TAMV) (median change in Revitive group:102.4% vs. sham group: -9.1%, p < .0001) and peak venous velocity (PV) (median change in Revitive group: 264.8% vs. sham group: -6.8%, p < .0001) during device use at week 0. Similar improvements were seen at week 6.

Change in Venous Hemodynamics From Baseline for Sham and Revitive Groups During Devise Usage

Significantly higher improvement in TAMV (Revitive: 8.9% vs. sham: -14.8%, p = .001) and PV (Revitive: 16.0% vs. sham: -8.0%, p = .003) at week 0 after the device was turned off

Reduced median increase in limb volume4

Patients in the Revitive group had a lower increase in limb volume at week 0 and week 6 than those in the sham group (week 0: Revitive 0.8% vs. sham 2.0%, p = .0001; week 6: Revitive 1.0% vs. sham 1.2%, p = .002).4

High compliance rate without adverse events4

Revitive achieved an overall compliance rate of 94.6% with no reported adverse events.4


How to use Revitive

Revitive can be used at home for 30-60 minutes a day for a maximum of 3 hours with EMS stimulation.1


Contraindications

Revitive should not be used in patients with a cardiac pacemaker, implanted defibrillator, or other implanted electronic device, pregnancy, undiagnosed pain syndromes, or deep vein thrombosis (DVT).

Warnings

Revitive is not intended to manage or reverse any underlying condition or provide long-term results. It is intended to provide relief of symptoms.

Do not apply foot pads directly on these areas:

  • Open wounds or rashes, swollen, red, infected, or inflamed areas or skin eruptions (such as phlebitis, thrombophlebitis, varicose veins, cellulitis)
  • Areas that are cold and numb, turning red and then black, and/or gangrene
  • On or close to malignant tumors
  • Areas treated with radiotherapy within the past 6 months
  • Reproductive organs
  • Avoid areas that are pale, shiny, smooth, and dry

Adverse Reactions

Skin irritation and burns beneath the electrodes have been reported with the use of powered muscle stimulators.


References:

  1. Revitive User’s Manual. Rosemont, IL; Actegy Health Inc; 2019.
  2. Varatharajan L, Williams K, Moore H, Davies AH. The effect of footplate neuromuscular electrical stimulation on venous and arterial haemodynamics. 2015 Oct;30(9):648-650. DOI: 10.1177/0268355514542682.
  3. Babber A, Ravikumar R, Onida S, Lane TRA, Davies AH. Effect of footplate neuromuscular electrical stimulation on functional and quality-of-life parameters in patients with peripheral artery disease: pilot, and subsequent randomized clinical trial. Br J Surg. 2020;107(4):355-363. doi:10.1002/bjs.11398.
  4. Ravikumar R, Williams KJ, Babber A, Lane TRA, Moore HM, Davies AH. Randomised controlled trial: Potential benefit of a footplate neuromuscular electrical stimulation device in patients with chronic venous disease. Eur J Vasc Endovasc Surg. 2017;53(1):114-121. doi:10.1016/j.ejvs.2016.09.015.
* For use as an adjunctive treatment to temporarily reduce lower extremity pain, swelling and cramping. Revitive Circulation Booster should not be used if you are fitted with an electronic implant, such as a pacemaker or AICD, being treated for, or suspect you have, a deep vein thrombosis or are pregnant. © 2019 Actegy Health. All Rights Reserved.