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Product approval

CE Mark Granted to FlowAid Medical FA100 SCCD

The FA100 SCCD was designed with the patient in mind as it is easy to use, allows complete mobility and operates without external pressure to the leg

FlowAid Medical Technologies has received CE mark approval for its FA100 SCCD Sequential Contraction Compression Device that delivers sequential compression therapy. After many years of research and development, and the involvement of many multidisciplinary professionals, FlowAid has developed this new approach enabled by patient feedback in the administration of sequential compression therapy. The FA100 SCCD was designed with the patient in mind as it is easy to use, allows complete mobility and operates without external pressure to the leg.

According to the company, sequential compression is the current standard of care for treating many forms of circulatory disorders in the lower extremities. Previously, this was achieved with external pressure to the leg. Now, FlowAid can provide care for treating many forms of circulatory disorders in the lower extremities through a number of electrically stimulated controlled contractions.

By contracting the calf muscles, the natural mechanisms that regulate and control blood flow are activated causing increased venous outflow from the leg through the following four actions:
• Activation of the natural venous muscle pump.
• Forming a pattern of muscle contractions in a peristaltic wave form along the longitudinal axis from distal to proximal.
• Activation of the musculature induces a metabolic demand creating an increased arterial inflow.
• Chronic activation of the musculature releases natural angiogenic factors which form new blood vessels and increases muscle mass enabling a better muscle pump action.

The primary mechanism of the FlowAid FA100 SCCD is to compress the veins in the lower leg by using specifically controlled wave of peristaltic contractions, distal to proximal, causing an increase in venous outflow from the limb. This is useful in the treatment of chronic venous insufficiency, lymphedema and the complications of these diseases. Keeping a constant flow will also prevent deep vein thrombosis (DVT) from occurring. Secondarily, by increasing venous outflow, the FA100 SCCD also increases arterial inflow. This is useful for the treatment of peripheral arterial disease (PAD), arterial insufficiency and the complications that may develop from these conditions. The FA100 SCCD has been useful in treating micro-ischaemic neuropathy by hyperperfusing the limb.

The device has also been approved for use in Canada.