Sanjeevani Electronic Health Records IEEE Oxford UK Presentation
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FlowKeepers
Device for Preventing Circulatory Ailments
Patented, developed and ownedby
Amiram Katz, MD,
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The Problem Medical Applications:
• Patients at risk for developing DVT & PE (VTE)
• Patients with non-healing wounds of different etiologies
• Patients with limb edema of different etiologies
• Patients with ischemia of the extremities
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The Problem General Consumer
• Healthy individuals with leg swelling and discomfort on prolonged travels
• Healthy individuals on long travels with risk factors for DVT (obesity, hormone replacement therapy/ oral contraceptives, smoking, age>40, smoking, varicose veins and others – see below)
• Healthy concerned individuals on long travels
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The Problem: Medical –Pulmonary Embolism
• Should be reported as the third leading (>200,000 - next slide) cause of death in the US after heart (941,000) and cancer (541,000) related deaths.
• In July 2000 statistics, stroke was reported as third, withonly 158,000 fatalities.
• PE is under reported due to declining autopsy rates .
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The Problem (PE):
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The Problem Deep Vein Thrombosis (DVT) & PE =VTE
(venous thrombo embolism):• 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 clot more than normal (thrombophillias), 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 risk annually – between 10 – 30 million Americans
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The Problem Embolic Strokes
• Embolic strokes, due to patent foramen ovale (PFO – a virtual hole communicating both sides of the heart), which is common (10-20% of the population) which allows paradoxic (from the right atrium to the left atrium) emboli, which are not included in VTE statistics.
• Many of the acute strokes taking place in prolonged flights, might be secondary to paradoxic emboli. They can be trigerred by lifting a heavy suite case, or involved in any activity that increase intra abdominal pressure.
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The Problem (VTE):American College of Chest Physicians
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The Problem - VTE
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The Problem - VTE
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The Problem Chronic Ulcers - Diabetes:(Data from: Diabetes 1996 Vital Statistics and,
Levin ME. Diab Care 1995; 18:1983-1993)
• 16 Million Americans with Diabetes. Of them,• 5%-6% admitted annually with non-healing ulcers
of their feet (One Million Patients). Of them,• Close to 70,000 end up with amputations with an
annual cost of $1.5 Billion. • $10 Billion spent annually on Diabetic Wound
Care (Diabetic non-healing ulcers).
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The Problem Chronic Ulcers:Venous Insufficiency
(Rudolph DM. J Wound Ostomy Continence Nurs 1998; 25:245-55, and
Onegnace K, Phillips T. Emerg Med 1993; 25:45-53
• 1% of the population and 3.5% of people >65 years, suffer from venous ulcers (3:1 women/men)
• Recurrence rate of venous ulcers is 70%. • The estimate per episode cost of care can exceed
$40,000. • $5 Billion spent annually on Venous Ulcer Care.
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The Problem: Prolong Travels in Tight Seats
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The Problem: “Economy Class Syndrome”• The Aviation Health Institute, Oxford, UK, estimates
that there are 2,000 deaths and 30,000 flight related VTE cases a year in Britain.
• 0.5 Billion passengers on flights > 6 hrs in, into and out of USA annually.
• 4 hrs of travel (plane, train or car) = x4 chance of suffering from DVT or PE (Ferrari et al. Chest 1999; 115:440-444).
• Prolonged air travel is associated with 10% incidence of L.E. venous thrombi confirmed by Doppler studies (mostly sub clinical - Scurr Lancet 2001; 357:1485-9)
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Our Solution:
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Our 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 stimulation parameters of the TENS Units used (patients could not tolerate the high frequency stimulation)
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Our 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 studied in 20
volunteers– Electrodes optimal size, shape and structure were
determined
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Our Solution:• Effective calf contraction every 10 seconds
resulting in:– venous emptying (it takes 5 seconds to refill an emptied
vein) 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
• reduction of peripheral resistance
– activation of the fibrinolytic (clot preventing) system
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Our Solution: D-preVenT™(disposable non-woven wrap for hospital environment)
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Our Solution: FlowKeepers®
(Durable structure for prolonged use)
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FlowKeepers® - Next Generation
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FlowKeepers® - Next Generation(With reusable cuff)
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How does it work?
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Approved Institution Review Board (IRB) Studies We 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
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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.
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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
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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
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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)
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Pacemakers/ Internal Defibrillators Safety
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Who is not receiving effective non-pharmacologic thrombo-
prophylaxis?
• 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
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Regulatory Status• 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”
• We have identified predicate devices (substantially equivalent)
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Current Certificates of Assessment –
• EC Det Norske Veritas: Certificate No. 2002-OSL-MDD-0089
• CE 0434