Veinoplus is a class IIa medical device

Medical device

A medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery . Whereas medicinal products achieve their principal action by pharmacological, metabolic or immunological means. Medical devices act by other means like physical, mechanical, thermal,...

 with CE marking

CE mark

CE marking is a mandatory conformity mark for products placed on the market in the European Economic Area . With the CE marking on a product the manufacturer ensures that the product conforms with the essential requirements of the applicable EC directives...

. It is indicated for the treatment of vascular diseases. This is a neuromuscular stimulator developed by an American scientist, Jozef Cywinski

Jozef Cywinski

Jozef Cywinski , born on the 13th of March 1936 in Warsaw, Poland, is an American scientist, specialist in the field of biomedical engineering and specifically in electrical stimulation of human tissues. His work has been the subject of 12 patents, 2 books and over 100 scientific publications...

.

History

• 2004: Veinoplus design
• 2005: Princeps study (first published clinical study)
• 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

Electrotherapy

Electrotherapy is the use of electrical energy as a medical treatment In medicine, the term electrotherapy can apply to a variety of treatments, including the use of electrical devices such as deep brain stimulators for neurological disease. The term has also been applied specifically to the use of...

. 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

Electrical muscle stimulation

Electrical muscle stimulation , also known as neuromuscular electrical stimulation or electromyostimulation, is the elicitation of muscle contraction using electric impulses...

 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.

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

Association for the Advancement of Medical Instrumentation

The Association for the Advancement of Medical Instrumentation founded in 1966, is a voluntary consensus organization which promotes knowledge and use of medical instrumentation. It creates standards, educates and certifies technicians, and publishes technical documents, books, periodicals, and...

 and American National Standards Institute

American National Standards Institute

The American National Standards Institute is a private non-profit organization that oversees the development of voluntary consensus standards for products, services, processes, systems, and personnel in the United States. The organization also coordinates U.S. standards with international...

 (AAMI / ANSI ; NS-4; 1986/2002). Moreover, the device doesn’t generate excessive electromagnetic interference. Thus it can be used in a plane, except during take-off and landing. Finally, a study on pregnant women has proven that Veinoplus has no side effects on foetus and pregnancy.

Physiological properties

Veinoplus activates the calf muscular pump which is responsible for 80% of the venous return. The pulsating calf contractions compress deep veins

Vein

In the circulatory system, veins are blood vessels that carry blood towards the heart. Most veins carry deoxygenated blood from the tissues back to the heart; exceptions are the pulmonary and umbilical veins, both of which carry oxygenated blood to the heart...

 and pump the venous blood against gravity towards the heart.

We can highlight 3 principal hemodynamic effects:

• 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

Chronic venous insufficiency

Chronic venous insufficiency or CVI is a medical condition where the veins cannot pump enough oxygen-poor blood back to the heart. It is sometimes referred to as an "impaired musculovenous pump", this is due to damaged or "incompetent" valves as may occur after deep vein thrombosis or phlebitis...

 symptoms:

• painful or heavy legs
  Heavy legs
  Heavy legs is an alleged medical condition, described as an "unpleasant sensation of pain and heaviness" in the lower limbs. It is recognised primarily in France, and to a lesser extent elsewhere....
  
  
• edema
  Edema
  Edema or oedema ; both words from the Greek , oídēma "swelling"), formerly known as dropsy or hydropsy, is an abnormal accumulation of fluid beneath the skin or in one or more cavities of the body that produces swelling...
  
  
• night cramps
  Cramp
  Cramps are unpleasant, often painful sensations caused by muscle contraction or over shortening. Common causes of skeletal muscle cramps include muscle fatigue, low sodium, and low potassium...
  
  
• restless legs
• post-thrombotic syndrome
  Post-thrombotic syndrome
  Post-Thrombotic Syndrome is the term used to describe signs and symptoms that may occur as long-term complications of deep vein thrombosis . It may also be referred to as post-phlebitic syndrome or venous stress disorder.-Incidence of PTS:...
  
  .

Veinoplus could also ease chronic venous ulcer

Venous ulcer

Venous ulcers are wounds that are thought to occur due to improper functioning of venous valves, usually of the legs. They are the major cause of chronic wounds, occurring in 70% to 90% of chronic wound cases...

 healing.

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
• overweight
• lack of physical exercise
• high heat.

Contra-indications

The only contra-indication of Veinoplus is wearing a pacemaker

Artificial pacemaker

A pacemaker is a medical device that uses electrical impulses, delivered by electrodes contacting the heart muscles, to regulate the beating of the heart...

.

External links

• Product website
• Company website (ISO 9001
  ISO 9000
  The ISO 9000 family of standards relates to quality management systems and is designed to help organizations ensure they meet the needs of customers and other stakeholders . The standards are published by ISO, the International Organization for Standardization, and available through National...
  
   et ISO 13485
  ISO 13485
  ISO 13485 is an ISO standard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices...
  
  )