Veinoplus

Veinoplus is a class IIa medical device with CE marking. It is indicated for the treatment of vascular diseases. This is a neuromuscular stimulator developed by an American scientist, Jozef Cywinski.

History

2004: Veinoplus design
2005: Princeps study (first published clinical study) ^[1]
2011: Distributed in 25 countries.

Description

Veinoplus is composed of a pocket-size device linked to two electrodes. The device has three buttons: a central one to turn on and off the device and two buttons marked “+” and “-” to adjust the intensity of stimulation. The electrodes have to be placed on the calf: either both electrodes on one calf if the venous disease affects only one leg, or one electrode on each calf if the pathology concerns both legs.

Veinoplus technology

Veinoplus technology is based on the principle of electrostimulation. Thanks to a 9V battery, the device delivers electrical impulses with low frequency and low voltage. Input power is below 0.3W and output power is under 0.05W. The difference between Veinoplus and others electrical muscle stimulators is due to the waveform of the impulses. With this unique waveform, the electrical field can deeply get through the calf and so stimulate an important volume of tissue. As a consequence, Veinoplus triggers deep muscular contractions even if both electrodes are over one meter apart, for instance with one electrode on each calf.^[2]

Veinoplus produces safe and painless electrical impulses. Actually, the signal's intensity is below limits authorized by the Association for the Advancement of Medical Instrumentation and American National Standards Institute (AAMI / ANSI ; NS-4; 1986/2002). Moreover, the device doesn't generate excessive electromagnetic interference.^[3] Thus it can be used in a plane, except during take-off and landing. Finally, a study on pregnant women^[4] has proven that Veinoplus has no side effects on foetus and pregnancy.

Clinical data

Physiological properties

Veinoplus activates the calf muscular pump which is responsible for 80% of the venous return. The pulsating calf contractions compress deep veins and pump the venous blood against gravity towards the heart.

We can highlight 3 principal hemodynamic effects:^[1]^[5]^[6]

removal of venous stasis
increase of venous outflow in terms of volume and velocity
inhibition of reflux in superficial and deep veins.

Indications

Veinoplus is indicated for the treatment of chronic venous insufficiency symptoms:^[1]^[6]^[7]

painful or heavy legs
edema
night cramps
restless legs
post-thrombotic syndrome.^[5]^[8]

Veinoplus could also ease chronic venous ulcer healing.^[9]

Veinoplus can be used either by patients suffering from venous disease or at risk of venous disorders:

prolonged immobilization (long flights, jobs with a prolonged sitting or standing position...)
varicose veins
pregnancy^[4]
overweight
lack of physical exercise
high heat.

Contra-indications

The only contra-indication of Veinoplus is wearing a pacemaker.^[3]

References

^ ^a ^b ^c Dr F. Zuccarelli, Dr J. Launay, Dr J. Lemagrex, Pr R. Mollard, P Fargier, M. Pujo. Activation de la pompe musculaire du mollet par électrostimulation Veinoplus®. Angéiologie. 2005; 57:48-54
^ Marquage CE 0535.
^ ^a ^b International Standard IEC 60601-2-10 Medical electrical equipment. Particular requirements for the safety of nerve and muscle stimulators
^ ^a ^b Le Tohic, A.; Bastian, H.; Pujo, M.; Beslot, P.; Mollard, R.; Madelenat, P. (January 2009). "Effets de l'électrostimulation par Veinoplus® sur les troubles circulatoires des membres inférieurs chez la femme enceinte. Étude préliminaire". Gynécologie Obstétrique & Fertilité. 37 (1): 18–24. doi:10.1016/j.gyobfe.2008.09.019. PMID 19119049.
^ ^a ^b Griffin, M.B.; Nicolaides, A.N.; Bond, D.; Geroulakos, G.; Kalodiki, E. (2010). "The Efficacy of New VEINOPLUS Stimulation Technology to Increase Venous Flow and Prevent Venous Stasis". Journal of Vascular Surgery. 51 (3): 790. doi:10.1016/j.jvs.2009.11.012.
^ ^a ^b Griffin, M.; Nicolaides, A.N.; Bond, D.; Geroulakos, G.; Kalodiki, E. (2010). "The Efficacy of a New Stimulation Technology to Increase Venous Flow and Prevent Venous Stasis". European Journal of Vascular and Endovascular Surgery. 40 (6): 766–771. doi:10.1016/j.ejvs.2010.06.019. PMID 20650668.
^ Bogachev V. Y., Golovanova O.V., Kuznietzov A.H., Stchekoian A.O. Electrostimulation par Veinoplus, une nouvelle méthode pour le traitement de l'insuffisance veineuse chronique des membres inférieurs. Phlebology (Russ. Assoc. of Phlebology & IUP) 2010; Volume 1, Issue 4 pages 22-25
^ Soriano C., Moll S., Deal A. Efficacy and optimal use of a portable electrical muscle stimulator (Veinoplus) to improve symptoms of post-thrombotic syndrome. Poster presented at the Annual scientific Symposium 2010 of the Hemophilia and Thrombosis Research Society (HTRS). Abstract (page 30) published by HTRS
^ Dr F. Zuccarelli, J. Lemagrex, M. Pujo. Sur un cas de guérison d’une ulcération chronique de 50 ans d’âge, par utilisation de Veinoplus. Angéiologie. 2006 Vol. 58, n°4

External links

Product website
Company website (ISO 9001 et ISO 13485)

[zuccarelli-1] Dr F. Zuccarelli, Dr J. Launay, Dr J. Lemagrex, Pr R. Mollard, P Fargier, M. Pujo. Activation de la pompe musculaire du mollet par électrostimulation Veinoplus®. Angéiologie. 2005; 57:48-54

[2] Marquage CE 0535.

[iec-3] International Standard IEC 60601-2-10 Medical electrical equipment. Particular requirements for the safety of nerve and muscle stimulators

[le_tohic-4] Le Tohic, A.; Bastian, H.; Pujo, M.; Beslot, P.; Mollard, R.; Madelenat, P. (January 2009). "Effets de l'électrostimulation par Veinoplus® sur les troubles circulatoires des membres inférieurs chez la femme enceinte. Étude préliminaire". Gynécologie Obstétrique & Fertilité. 37 (1): 18–24. doi:10.1016/j.gyobfe.2008.09.019. PMID 19119049.

[nicolaides-5] Griffin, M.B.; Nicolaides, A.N.; Bond, D.; Geroulakos, G.; Kalodiki, E. (2010). "The Efficacy of New VEINOPLUS Stimulation Technology to Increase Venous Flow and Prevent Venous Stasis". Journal of Vascular Surgery. 51 (3): 790. doi:10.1016/j.jvs.2009.11.012.

[griffin-6] Griffin, M.; Nicolaides, A.N.; Bond, D.; Geroulakos, G.; Kalodiki, E. (2010). "The Efficacy of a New Stimulation Technology to Increase Venous Flow and Prevent Venous Stasis". European Journal of Vascular and Endovascular Surgery. 40 (6): 766–771. doi:10.1016/j.ejvs.2010.06.019. PMID 20650668.

[7] Bogachev V. Y., Golovanova O.V., Kuznietzov A.H., Stchekoian A.O. Electrostimulation par Veinoplus, une nouvelle méthode pour le traitement de l'insuffisance veineuse chronique des membres inférieurs. Phlebology (Russ. Assoc. of Phlebology & IUP) 2010; Volume 1, Issue 4 pages 22-25

[8] Soriano C., Moll S., Deal A. Efficacy and optimal use of a portable electrical muscle stimulator (Veinoplus) to improve symptoms of post-thrombotic syndrome. Poster presented at the Annual scientific Symposium 2010 of the Hemophilia and Thrombosis Research Society (HTRS). Abstract (page 30) published by HTRS

[9] Dr F. Zuccarelli, J. Lemagrex, M. Pujo. Sur un cas de guérison d’une ulcération chronique de 50 ans d’âge, par utilisation de Veinoplus. Angéiologie. 2006 Vol. 58, n°4

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