Published Studies
Sequential Contraction Compression Therapy Raises Foot Temperature in Patients with Peripheral Arterial Disease
Jonathan Rosenblum, Dimitry Gimmelreich, Sean Rosenblum
Published in Journal of Vascular Diagnostics and Interventions 2016:4 39–43
Sequential Contraction Compression Devices Reduce Leg Circumference in Patients with Chronic Venous Insufficiency
D. Gimmelreich, V. Karsilnikov, Litman & J. Rosenblum
Published in Journal of Vascular Medicine & Surgery, Gimmelreich et al., Vasc Med Surg 2016, 4:4
The Effect of a Sequential Contraction Compression Device on a Hypoesthetic Diabetic Foot: A Case Report
J. Rosenblum, N. Greenberg, & S. Weiss
Published in Medical Reports & Case Studies, Rosenblum et al. 2016, 1:3
Sequential Contraction Compression has a Positive Effect on Patients with Peripheral Arterial Disease
Jonathan Rosenblum, Dimitry Gimmelreich, & Nachum Greenberg
Published in the Journal of Novel Physiotherapies, Rosenblum et al. 2016, 6:3
Sequential Contraction Compression Device Therapy affects Symptomatic Diabetic Peripheral Neuropathy
Jonathan Rosenblum, Leib Litman and Nachum Greenberg
Published in Journal of Diabetic Complications & Medicine
An Evaluation of a Novel Compression Device on Popliteal Venous Blood Flow
David Shashar, Jonathan Rosenblum, Michael Miller, Eitan Heldinberg and Jeremy Tamar.
Published in Angiology, Shashar et al., Angiology 2016, 4:2
Sequential Contraction Compression Device Aids in the Healing of an Ischemic Foot Ulceration in a Chronic Dialysis Patient: A Case Report
Jonathan Rosenblum
Published in Research and Reviews: Journal of Clinical and Medical Case Studies
Articles
The Effectiveness of FlowAid FA 100 Muscle Pump Activation System (MPA) at increasing microcirculation velocity in PAD Patients
Dr. Jonathan Rosenblum PDM, Head of Diabetic Foot Care Department, Shaarei Zedek Hospital, Jerusalem, Israel; Adjunct Clinical Instructor, NY College of Podiatric Medicine, New York, NY, USA.
Etiology Lower Limb Venous Insufficiency
by Jeff Voigt
A Novel portable Muscle Pump Activator System (MPA) FlowAid FA 100 to enhance venous return and stimulate arterial blood flow in the extremities, a preliminary study
Dr. Jeremy Tamir MD Plastic Surgery, Sheba Medical Center, Israel and Halstead Wound Care Center, Kansas, USA
The Effectiveness of FlowAid FA 100 Muscle Pump Activation System (MPA) at forefoot temperature changes in PAD patients
Dr. Jonathan Rosenblum PDM Head of Diabetic Foot Care Department, Shaarei Zedek Hospital, Jerusalem, Israel, New York College of Podiatric Medicine, New York, NY, USA.
The Effectiveness of FlowAid FA 100 Muscle Pump Activation System (MPA) at pain reduction
Dr. Jonathan Rosenblum PDM, Head of Diabetic Foot Care Department, Shaarei Zedek Hospital, Jerusalem, Israel, New York College of Podiatric Medicine, New York, NY, USA.
Posters and Presentations
Reversing Diabetic Sensory Neuropathy with a Novel Electro-muscular Physiologic Stimulator
Elevating Arterial Blood Flow in Ischemic Diabetic Wound Patients with an External, Portable Electro-Muscular Device
A New Electro-Muscular Blood Flow Stimulator Assisting in the Treatment of Severely Infected and Ischemic Diabetic Wound
Revisiting Compression Therapy – Electric Muscle Pump Activation and the Peripheral Vascular System
Revisiting Compression Therapy – Electric Muscle Pump Activation and the Peripheral Vascular System
The use of FlowAid FA100, a novel device, for management of DFUs and ischaemic pain, evidenced by a series of case studies
Peripheral Vascular Disease (PVD)
Peripheral Vascular Disease (PVD) refers to diseases of blood vessels outside the heart and brain. It’s often a narrowing of vessels that carry blood to the legs, arms, stomach or kidneys causing the restriction of blood flow.
There are two types of these circulation disorders:
Functional: peripheral vascular diseases don’t have an organic cause. They don’t involve defects in blood vessels’ structure. They’re usually short-term effects related to “spasm” that may come and go. Raynaud’s disease is an example. It can be triggered by cold temperatures, emotional stress, working with vibrating machinery or smoking.
Organic: peripheral vascular diseases are caused by structural changes in the blood vessels, such as inflammation and tissue damage. Peripheral artery disease is an example. It’s caused by fatty buildups in arteries that block normal blood flow.
What are the symptoms?
Symptoms of PVD range from: pain, weakness, or cramping in muscles due to decreased blood flow; sores, wounds, or ulcers that heal slowly or not at all; noticeable change in color (blueness or paleness) or temperature (coolness) when compared to the other limb; diminished hair and nail growth on affected limb and digits.
Who is at risk?
Smokers are ten times more at risk than any other population for developing PVD, and it is the single most important modifiable cause. Other high risk populations include diabetics, people with dyslipidemia or high cholesterol, and hypertension. Risk of developing PVD also increases in people who are: over the age of 50, male, obese, or have a personal history of vascular disease, heart attack, or stroke.
How can it be treated?
Methods for treating PVD range from smoking cessation; exercise and diet; controlling diabetes and blood pressure; surgery, including angioplasty, bypass surgery, or amputation
Treating Peripheral Vascular Disease (PVD) with FlowAid FA100 SCCD
The FlowAid FA100 SCCD works directly to pump venous blood out of the limb. This causes a reduction in the symptoms of venous insufficiency. In addition by directly stimulating the muscles of the leg, the FlowAid FA100 SCCD helps to tighten their hold around defective valves thus reducing the reflux in the venous system in the future.
Peripheral Arterial Disease (PAD)
What is it?
Peripheral Artery Disease (PAD) is a condition similar to coronary artery disease and carotid artery disease. In PAD, fatty deposits build up in the inner linings of the artery walls. These blockages restrict blood circulation, mainly in arteries leading to the kidneys, stomach, arms, legs and feet.
What are the symptoms?
In its early stages a common symptom is cramping or fatigue in the legs and buttocks during activity. Such cramping subsides when the person stands still. This is called “intermittent claudication.” People with PAD often have fatty buildup in the arteries of the heart and brain. Because of this association, most people with PAD have a higher risk of death from heart attack and stroke. Techniques used to diagnose PAD include a medical history, physical exam, ultrasound, X-ray angiography and Magnetic Resonance Imaging Angiography (MRA).
Who is at risk?
Smokers are ten times more at risk than any other population for developing PAD, and it is the single most important modifiable cause. Other high risk populations include diabetics, people with dyslipidemia or high cholesterol, and hypertension. Risk of developing PAD also increases in people who are over the age of 50, male, obese, or have a personal history of vascular disease, heart attack, or stroke.
How can it be treated?
Methods for treating PVD range from smoking cessation; exercise and diet; controlling diabetes and blood pressure; surgery, including angioplasty, bypass surgery, or amputation.
Treating Peripheral Arterial Disease (PAD) with FlowAid FA100 SCCD
The FlowAid FA100 SCCD enhances the action of the body’s natural venous pump. By expelling venous blood a negative pressure is formed in the circulatory system in the lower extremity causing an increased arterial inflow. This new, increased arterial pressure both impacts the direct circulation that has been impaired as well as helping to generate new blood vessels aiding in the body’s natural formation of bypass.
Deep Vein Thrombosis (DVT)
What is it?
Deep Vein Thrombosis (DVT) is a condition in which a blood clot forms deep inside a vein, which either partially blocks, or completely blocks the flow of blood in the vein. DVT most often occurs in the lower limbs, including the thighs or the calves.
What are the symptoms?
Symptoms of DVT may include pain, tenderness, swelling or discoloration of the affected area, and skin that is warm to the touch.
Some deep vein thromboses are “silent” and may be present with minimal symptoms. A major risk associated with DVT is the development of Pulmonary Embolism (PE). PE occurs when a blood clot breaks loose from the wall of a vein and travels to the lungs, blocking the pulmonary artery or one of its branches. Patients with pulmonary embolism may experience shortness of breath, an apprehensive feeling, chest pain, rapid pulse, sweating, or a bloody cough.
Who is at risk?
While most victims are 60 years or older, DVT can strike anyone at risk. The leading medical factors that cause DVT are injury, immobility, surgery and/or illnesses that may include cancer, clotting disorders, and inflammatory diseases. Prolonged periods of sitting or lying still can slow down the blood flow and lead to blood “pooling,” or accumulating in the extremities. Because “killer legs” can creep up with little or no warning, the best tactic to take against DVT is prevention.
If you believe you may be experiencing DVT symptoms, talk to your doctor immediately. Patients who receive early treatment may reduce their chances of developing pulmonary embolism to less than 1%.
How can it be treated?
Methods for treating DVT range from avoiding long periods of immobility; limb elevation; heat application; prescription compression stockings; bandaging; sequential compression therapy, or ‘pressotherapy’; pneumatic compression devices.
Treating Deep Vein Thrombosis (DVT) with FlowAid FA100 SCCD
The FlowAid FA100 SCCD creates a constant flow of blood thus not allowing for any clotting/ hypercoagulation to occur. The motion of the circulation is gentle and replaces motion in the leg making it ideal for patients who have undergone surgery and are bedridden.
Venous Ulcers
What are they?
Venous ulcers are wounds that are thought to occur due to improper functioning of valves in the veins, usually of the legs. They are the major cause of chronic wounds, occurring in 70% to 90% of chronic wound cases. Venous ulcers tend to occur in the so-called Gaiter Area – halfway up the calf and down to just below the ankle. Veins drain blood from the feet & lower leg uphill to the heart. This blood has to be re-cycled through the heart and lungs to get rid of waste products and pick up oxygen. This system is important to keep the legs and feet healthy.
Two mechanisms assist in this uphill flow of blood:
Calf Muscle Pump – The Calf Muscle Pump are muscles used for walking and exercise which act as a pump by contracting and relaxing, helping to force blood uphill towards the heart.
One Way Valves – The veins in the legs have one-way valves which prevent blood flowing back downhill. If the valves do not work properly and do not close in the normal way blood will flow back downhill and cause congestion.
What are the symptoms?
The development of venous ulcers may lead to legs which are swollen and tender to touch. The skin may feel dry and itchy, have mottled brown or black staining, and may appear crusty in the gaiter area. The legs may also become painful when sitting down.
Who is at risk?
The following conditions indicate an increased risk for venous ulceration:
- A history of deep vein thrombosis, which can damage vein valves
- A family history of venous disease
- Lower-extremity edema, which increases the risk of tissue breakdown
Certain conditions are also linked with the development of venous leg ulcers including:
- High Blood Pressure
- Phlebitis
- Varicose Veins
- Fractures or Injuries
- Multiple Pregnancies
- Previous Surgery
- Sitting or standing for long periods
- Obesity
How can they be treated?
Methods for treating venous ulcers range from limb elevation; prescription compression stockings; bandaging; artificial skin treatment; corrective surgery; sequential compression therapy, or ‘pressotherapy’; pneumatic compression devices.
Treating Venous Ulcers with FlowAid FA100 SCCD
The FlowAid FA100 SCCD indirectly helps to hasten the closure of skin ulcerations. It does so by decreasing tissue edema thus reducing the pressure on the skin. It also helps to bring fresh blood and oxygen to the area. It is also instrumental in reducing pain.
Lymphadema – Edema
What is it?
Lymphedema is a condition in which damage to the lymphatic system causes the arms or legs to swell to several times their normal size. It also presents the potential for massive infections from even the smallest cuts or inflammation of the skin.
In the bloodstream, much of what we call blood is actually plasma, a clear fluid. When one sprains one’s ankle, much of the swelling is actually plasma that seeps out of micro capillaries into tissues around the injury. Most of this fluid is then reabsorbed into the bloodstream through small blood vessels. However, a small part of the fluid called “lymph” is picked up by lymphatic vessels instead, which carry it to a duct in the chest region which dumps it back into the primary bloodstream circulation. The lymph often contains bacteria, dead white cells which fight infection, fats and sometimes cancer cells that have been shed from a cancerous tumor. If one has normal lymph nodes, this debris would be filtered out. When lymph nodes or lymphatic vessels are damaged, there is no longer an area for lymph to flow. As fluid builds up, any cut or opening in the skin can ultimately result in infection or inflammatory processes such as cellulitis.
Lymphedema provides a veritable feast for resultant bacteria invading the system. Each infection can lead to scar tissue further damaging the lymph vessels which ultimately results in chronic recurring lymphedema and/or cellulitis.
Normal lymph nodes assist the lymph in moving throughout our body. A damaged lymphatic system loses its ability to pump or move lymph fluid, thus resulting in a lymph build-up.
What are the symptoms?
Symptoms may include severe fatigue, a heavy swollen limb or localized fluid accumulation in other body areas, including the head or neck, discoloration of the skin overlying the lymphedema, and eventually deformity (elephantiasis).
Who is at risk?
For some, lymphedema is genetic. Others acquire it following treatment for other diseases, predominantly cancer. The lymphatic system (specialized vessels through which a clear protein-rich fluid flows) is an under-recognized, but crucial part of our circulatory and disease-fighting system.
How can it be treated?
Methods for treating lymphedema range from limb elevation; prescription compression stockings; bandaging; manual lymph drainage; sequential compression therapy, or ‘pressotherapy’; pneumatic compression devices
Treating Lymphadema – Edema with FlowAid FA100 SCCD
The FlowAid FA100 SCCD directly pumps the blood and lymphatic drainage up through the venous system thus significantly reducing volume in the leg. Once the assisted drainage begins the body, while still not functioning optimally, will have an easier time moving the fluid with a decreased volume.
Peripheral Neuropathy
What is it?
Peripheral neuropathy is a problem with the nerves that carry information to and from the brain and spinal cord. This produces pain, loss of sensation, and inability to control muscles.
The peripheral nerves relay information from your central nervous system (brain and spinal cord) to muscles and other organs and from your skin, joints, and other organs back to your brain. Peripheral neuropathy occurs when these nerves fail to function properly, resulting in pain, loss of sensation, or inability to control muscles.
Peripheral neuropathy may involve damage to a single nerve or nerve group (mononeuropathy) or may affect multiple nerves (polyneuropathy).
There are numerous reasons for nerves to malfunction. In some cases, no cause can be identified.
What are the symptoms?
Damage to nerves can result from one of the specific conditions associated with neuropathy, including:
Diabetes (diabetic neuropathy)
Excessive alcohol use ( alcoholic neuropathy )
Neuropathy secondary to drugs (many drugs can cause neuropathy)
Ischemia (decreased oxygen and blood flow)
Who is at risk?
Peripheral neuropathy is very common. Some people have a hereditary predisposition for neuropathy.
Treating Peripheral Neuropathy with FlowAid FA100 SCCD
The FlowAid FA100 SCCD hyperperfuses the small blood vessels that feed the nerves in the leg. While these nerves became diseased because of a lack of blood flow and nutrition, the FlowAid FA100 SCCD brings them all the blood flow they need to repair themselves and begin functioning normally. The excessive pressure of the new inflow also helps to break the fibrin cuffs that are choking off the blood vessels to the nerves thus helping to create a lasting effect to the treatment.
Clinical Results
The following cases demonstrate the efficacy of FlowAid treatment.
Color Doppler Ultrasound (CDUS) imaging of the popliteal vein while being treated with the FlowAid FA100 SCCD
Flourescent IR Scanning of a patient with severe lymphedema; performed by Dr. Guido Giacalone, Leuven, Belgium
Baseline – No recognized Flow
Treated – Flow increase (peaks and widening of the vessels) by the induced compression caused by the FA100 contractions
Baseline
Treated
Treated – Widening of the vessel
Baseline
Treated
Patient: Male 64 Y/O
Diagnosis: Diabetic type II,Painful ischemic, Diabetic neuropathy and Severe PVD.
Results: Dramatic temperature increasing during 150 minutes of treatment. Temperature increased from 19° to 34°. Dramatic improvement in maximum walking distance. Pain relief.
Obtained with the courtesy of Dr. M. Lipot MD
Before
After
Patient: Male 65 Y/O
Diagnosis: Raynaud’s Phenomenon, Right foot toe measured 20.2° (Norm 33°)
Results: Dramatic temperature increasing during 60 minutes of treatment. Temperature increased from 20.2° to 34.8°.
Obtained with the courtesy of Dr. David Hen MD
Before
After
Other Results
The following cases demonstrate the efficacy of FlowAid treatment.
Patient: 64 Y/OFemale
Diagnosis: Diabetes Type 2 and currently receiving Dialysis 3 times weekly. Painful ischemic left foot with dry gangrene over the distal tips of toes 1-4. Scheduled for amputation.
Results: Over the 5 weeks of treatment the ischemic condition of the foot has been improved and there is a healthy brown color to the foot.
There is less pain and edema. The distal gangrene that was scheduled for amputation has resolved.
Toes 2, 3, and 4 have been debrided of all eschar and at last visit these toes were healed completely.
Obtained with the courtesy of Dr. Jonathan Rosenblum DPM
Before
After
Patient: 72 Y/O
Diagnosis: Rt leg- war injury in 1948. Vascular injury, very long recovery. Chronic and very painful heel ulcer.
Results: Full recovery and healing of the wound after 9 weeks of treatment, decreased pain, gradual wound closure, calf muscle contractures.
Obtained with the courtesy of Dr. Jeremy Tamir MD
Before
After
Patient:Female 60 Y/O
Diagnosis: Diabetes, severe PVD, S/P multiple peripheral vascular bypass. Isolated thigh ischemia Night and day pain-high usage of analgesics.
Results: Dramatic pain relief. Stopped all use of analgesics. Accelerated wound closure.
Obtained with the courtesy of Dr. Jeremy Tamir MD
Before
After
Patient: 62 Y/O Male
Diagnosis:Diabetes Type II. Hypertension.
Congestive heart failure. Severe PVD RL 0.35 ABI.
Sever pain. Large deep infected ulcer right heel.
Results: Complete wound healing. Less pain. ABI Increased from 0.35 to 0.47.
Obtained with the courtesy of Dr. M. Lipot MD
Before
After
Patient:78 Y/O Male
Diagnosis: Hypercholesterolemia, S/P mild C.V.A
Left lateral leg -2 year non-healing wound
Left lower extremity -mild weakness
Pain-rated as 8 (scale 0 -10)
Results: Marked improvement in wound appearance Pain reduction – rated 2-3 (Scale 0 -10)
Obtained with the courtesy of Dr. Michael S. Miller DO, FACOS, FAPWCA, CWS; The Wound Healing Centers. Bedford, IN, USA
Before
After
Patient: 52 Y/O Male
Diagnosis: Morbid obesity; chronic venous insufficiency D.M. type II. Severe venous ulcer, Wheelchair bound. Arterial Doppler-Biphasic DP and PT, ABI 1.2
Results: Ulcer healing within 11 days
Obtained with the courtesy of Dr. Michael S. Miller DO, FACOS, FAPWCA, CWS; The Wound Healing Centers. Bedford, IN, USA
Before
After
Cleared by the Food & Drug Administration
The FA100 SCCD is a CE approved device
13485:2003
License# 97539