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What is Venowave?

The Venowave is a lightweight, compact battery operated, peristaltic pump that generates a wave-form motion.  The mechanics behind the Venowave are based upon patented wave generating technology developed by John Saringer and licensed to SARINGER LS from Somawave Inc.

When worn firmly on the calf the Venowave produces upward volumetric displacement forcing blood from the feet and legs back to the heart. This increase in venous and lymph flow prevents blood pooling, clot formation, and the debilitating effects of several chronic circulatory diseases.



Ongoing research and enhancements to the Venowave has led to five versions being developed over the last few years. The latest version, the VW5, is shown at right. The VW5 is available in four models with varying wave frequency dependent upon the unique needs of the patient. The four models are: VW5-6, VW5-10, VW5-20 and the VW5-30. The second number refers to the number of full-length wave cycles the Venowave model performs in a minute. The Venowave is very compact with the device weighing only 260g and measuring about 3"x9".


Clinical Research

Initial Venowave Clinical Trial
The initial clinical evaluation of the Venowave began in 2001 with the McMaster Thrombosis Group, including Dr. Martin O'Donnell, Dr. Jack Hirsh, Dr. Jeff Ginsberg and Dr. Susan Kahn from McGill in Montreal. The title of the study was "Evaluation of a venous-return assist device to treat severe post-thrombotic syndrome (VENOPTS)". The trial examined a population of approximately thirty patients suffering from severe post thrombotic syndrome ("PTS").

An excerpt from the study summary is provided below:

"Severe post-thrombotic syndrome ("PTS") is responsible for considerable disability, reduced quality of life and increased health care costs. Current therapies are limited and often ineffective. We performed a two-centre,randomized,cross-over controlled trial to evaluate VenowaveTM, a novel lower-limb venous-return assist device, for the treatment of severe PTS. Eligible subjects were allocated to receive, in randomized order, Venowave for eight weeks and a control device for eight weeks.The eight week treatment periods were separated by a four-week period when no device was used (i.e. wash-out period). The primary outcome measure was a ‘clinical success' defined as: i) reported benefit from the device; and ii) moderate or greater improvement in symptoms of PTS; and iii) willingness to continue using the device."

The particular results from the clinical trial demonstrated that the Venowave provided up to an 80% increase in venous blood circulation in calf veins and 20 - 30% improvement in blood flow in veins of the thigh.  Subsequent studies involving patients who presented with chronic venous insufficiency caused by the PTS, showed improvement in symptoms without any serious side effects.  During the study periods, no cases of recurrent venous thromboembolism were reported.

As a result of this clinical trial a paper was published by Marcel Levi, Department of Vascular Medicine and Internal Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands. The title of the paper was "A long-awaited small step forward in the management of the post-thrombotic syndrome". The paper provided the following summary for the Venowave:

"In conclusion, the new device tested in the present study seems to be a promising new option that may in the future be added to our arsenal to improve the management of PTS."


Conditions Treated by the Venowave

Venowave is intended to be used by patients suffering from a wide variety of conditions resulting from poor peripheral venous circulation including post thrombotic syndrome, leg swelling due to venous valve incompetence, primary thrombosis, lymphedema and varicose veins. Collectively these conditions can be described as a class of circulatory diseases that result from a condition known as "chronic venous insufficiency". 

Chronic Venous Insufficiency
Chronic Venous Insufficiency occurs when valves in the veins of the leg fail.  The anatomy of veins is unique in that, when functioning properly, it allows only for the unidirectional flow of blood against the force of gravity toward the heart.  When the muscles of the leg contract, blood is forced up the veins to the heart.  The one-way valves within the veins close at the end of the contraction thereby preventing the blood from flowing back down the vein to the feet.  If these valves become damaged, however, blood flow becomes bi-directional, which over time can result in blood pooling in the legs and feet, and swelling of the veins to occur.  Veins may become rope-like in appearance, may discolor the skin, and ulceration may occur.  In addition, blood flow becomes much slower which can contribute to clot formation and the occurrence of emboli. 
 
Clinical Conditions of Chronic Venous Insufficiency
The following is a brief description of the clinical conditions that result from chronic venous insufficiency:

Deep Vein Thrombosis ("DVT") - is a blood clot, otherwise referred to as a thrombus, in a deep vein in the thigh or leg. The clot can break off as an embolus and make its way to the lung, where it can cause respiratory distress, respiratory failure or death. 

Post-Thrombotic Syndrome ("PTS") - is a condition described by the complications that may follow deep vein thrombosis (DVT) which may include persistent swelling (edema), pain, itchiness, ulceration, and infection. All of these complications result from the impaired return of blood through the veins of the lower leg to the heart.
 
Lymphedema - is a common chronic, debilitating condition in which excess fluid called lymph collects in tissues and causes swelling (edema).

Varicose veins - are bulging, swollen, purple, ropy veins, seen just under the skin, caused by damaged valves within the veins. They can also be caused by pregnancy, being severely overweight or by standing for long periods of time. 

Indications for Use
As previously referenced the "Indications for Use" that were approved by The FDA in the United States and by Health Canada for the Venowave  include:

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