FlowKeepers

Device for Enhancing Peripheral Circulation

FDA approval - Pending

by

Amiram Katz, MD,

Who needs FlowKeepers?

• Patients at risk for developing blood clots: deep vein thrombosis (DVT) & pulmonary embolism (PE) - collectively called venous thrombo- embolism (VTE)

• Patients with non-healing wounds

• Patients with swelling of their limbs

• Patients with ischemia (diminished blood supply) of the extremities

Who needs FlowKeepers?

• Healthy individuals with leg swelling and discomfort on prolonged travels

• People with risk factors for DVT (obesity, hormone replacement therapy/ oral contraceptives, smoking, age>40, smoking, varicose veins and others – see below) – on long travels

• Healthy concerned individuals on long travels

Pulmonary Embolism• Should be reported as the third leading

(>200,000 – see next slide) cause of death in the US after heart (941,000) and cancer (541,000) related deaths.

• In July’s 2000 statistics, stroke was reported as third, with only 158,000 fatalities.

• PE is under reported due to declining autopsy rates .

The Problem (PE):

DVT & PE = VTE• More than 1,000,000 Americans are reported to suffer

from VTE annually (98 Mayo Clinic Health Letter).• It is estimated that the real incidence of VTE is 5-10

times higher (most events are silent).• About 10% of healthy individuals have a genetic

tendency to make clots more than needed (thrombophilias), of which they are not aware (NEJM 2001;344:1222-1231

• People at VTE risk (other than genetic - see next slide) - probably make 20% - 50% of the population admitted to hospitals

• Total population at VTE risk each year – between 10 – 30 million Americans

The Problem Embolic Strokes

• Embolic strokes, due to patent foramen ovale (PFO – a virtual hole connecting both sides of the heart), which is very common (10-20% of the population) and allows paradoxical (from the right atrium to the left atrium) emboli , otherwise trapped by the lungs.

• PFO associated strokes are not included in VTE statistics.

• Many of the acute strokes taking place in long flights, might be secondary to paradoxical emboli. They can be triggered by lifting a heavy suite case, or any activity that increases abdominal pressure.

The Problem (VTE):American College of Chest Physicians

The Problem - VTE

The Problem - VTE

Non Healing Diabetic Leg Ulcers:(Data from: Diabetes 1996 Vital Statistics and,

Levin ME. Diab Care 1995; 18:1983-1993)

• 16 Million Americans suffer from Diabetes. Of them:

• 5%-6% admitted annually with non-healing ulcers of their legs (One Million Patients). Of them:

• Close to 70,000 end up with amputations with an annual cost of >$1.5 Billion.

• More than $10 Billion spent annually on Diabetic Wound Care (Diabetic non-healing ulcers).

Chronic Ulcers Due to Venous Insufficiency(Rudolph DM. J Wound Ostomy Continence Nurs 1998;

25:245-55, andOnegnace K, Phillips T. Emerg Med 1993; 25:45-53

• 1% of the population and 3.5% of people age >65 suffer from venous ulcers (3:1 women/men)

• Recurrence rate of venous ulcers is 70%. • The estimate per episode cost of care exceeds

$40,000. • More than $5 Billion spent annually on Venous

Ulcer Care.

The Problem: Prolong Travels in Tight Seats

The “Economy Class Syndrome”

• The Aviation Health Institute, Oxford, UK, estimates that there are >2,000 deaths and >30,000 flight related VTE annually in the UK.

• More than 0.5 Billion passengers on flights > 5 hrs in, into and out of the US annually.

• 4 hrs of travel (plane, train or car) = x4 chance of suffering from a DVT or PE (Ferrari et al. Chest 1999; 115:440-444).

• Prolonged air travel is associated with 10% , Doppler confirmed , blood clots (mostly sub clinical - Scurr Lancet 2001; 357:1485-9)

The Solution:

The Solution:

• Electric muscle stimulation was shown to be effective in DVT prevention since the 60’s (Browse et al. BMJ 1970, 3, 615-618)

• It was abandoned due to clumsy instrumentation and old technology (diode boxes, metal electrodes, etc.)

• Later attempts to implement modern electronics to the devices were not successful due to wrong stimulation parameters

The Solution:

• Fifteen years of R&D with:– Several US issued patents and Brands and two

generations of manufactured devices

• Clinical work during which:– Optimal current parameters were determined and

patented– Skin resistance and morphometric variants were studied

in 20 volunteers– Electrode optimal size, shape and structure were

determined

The Solution:• Effective calf contraction every several seconds

resulting in:– venous emptying by active muscle contraction– increase in venous flow velocity in the central

femoral vein (CFV) of 100%-1000% – improved arterial blood flow with

• improved oxygenation (TcpO2)• reduction of peripheral resistance

– activation of the fibrinolytic (clot dissolving) system

Our Solution: D-preVenT™(disposable non-woven wrap for hospital environment)

Our Solution: FlowKeepers®

(Durable structure for prolonged use)

FlowKeepers® - Next Generation

FlowKeepers® - Next Generation(With reusable cuff)

How does it work?

Approved Institution Review Board (IRB) Studies Completed:

• Doppler studies in 10 healthy volunteers –statistically significant increases in flow, measured at the central femoral vein (up to 4 fold increase when lying and sitting and up to 10 fold increase, standing).

• Patients with ankle edema of various etiologies - statistically significant relief of the treated limb:

- Bilateral edema: 3.7-9.5% reduction of leg volume in one day of use

- Unilateral edema: 7.7-39% reduction of leg volume in two days of use

Additional Studies Done:

• TcpO2 (transcutaneous oxygen pressure) measurements in

patients with foot ulcers, PVD and healthy volunteers, showed 20% 100% increase with calf stimulation when measured at the MTP (base of the toe) joint area.

A Patient’s Story

“July 19, 2000, I had my first operation due to blood clot in my leg. I needed a second operation, but my leg and ankle were too swollen for surgery. About July 26th, I received a FlowKeeprs and used it about seven or eight hours a day. It helped to reduce the swelling in my ankle from 27.5 to under 24cm in circumference in about five days and I could proceed with my surgery.About two weeks after my second operation, my leg got swollen and painful again. Around August 8th, I was able to use the FlowKeepers again when my surgery wound closed. It helped to keep the swelling down and reduce pain so I was able to walk around.It reduces my need for pain medications and I am still using it for 5-6 hours a day. Today, one year later, if I do not use FlowKeepers for one or two days, I notice that by the end of the day, the swelling and pain has returned.” Geza TothFairfield, Connecticut

Amiram,

The FlowKeepers device worked like a charm! It worked flawlessly the entire (flight) duration of my recent trips to Spain and Calgary. It provided great relief as my ankles were not swollen at all. A true test of its effectiveness!

Even while sleeping, the device is at work. All I am required to do is turn it on and off and the device does the rest. Remarkable!!

I continue to read with great interest the best advice to combat this dreaded ailment ('Economy Class Syndrome') but am now more than confident that you have a winner.

I have recommended this product to all of the travelers in my office.

Louis A. Sorrentino III, Vice President – SH&E Safety PracticeManaging Director, Internal Evaluation Program, Flight Safety Foundation

Contraindications

• Absolute:– Acute DVT

– Broken, infected or irritated skin at the electrode attachment area

– Known allergy to electrode gel

– Pregnancy

– Age < 18

• Relative:– Pacemakers and internal defibrillators (see next slide)

Pacemakers/ Internal Defibrillators Safety

Who is not receiving effective non-pharmacologic thrombo-prophylaxis

(clot prevention treatment)?

• All patients undergoing one day surgery, recovering motionlessly at home

• All patients undergoing cosmetic surgery at the physician’s office

• All patients discharged from the hospital

• Many patients with risk factors for VTE

FDA Approval - Pending

• FDA approval route: 510K• The device is categorized as a Powered Muscle

Stimulator• This class has two existing standard indications of

relevance (classified under 21 CFR 890.5850):– “3. Increasing local blood circulation”– “5. Immediate post surgical stimulation of calf

muscles to prevent venous thrombosis”