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Hemova ES Diabetes Mine

Hemova ES Diabetes Mine

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In 2008 over 48,000 Americans with diabetes began treatment for end stage kidney disease. This brought the total number of patients on kidney dialysis due to diabetes to over 202,000. To start dialysis, patients undergo surgery to make a connection to the blood using devices that fail in as little as one year costing Medicare $1 billion/year in new surgeries and high patient morbidity. We are providing a new solution for a long-lasting connection to the blood. Our device will reduce the number of surgeries required to fix or replace failed blood access devices in patients saving Medicare hundreds of millions of dollars per year and reducing dialysis patient morbidity.
In 2008 over 48,000 Americans with diabetes began treatment for end stage kidney disease. This brought the total number of patients on kidney dialysis due to diabetes to over 202,000. To start dialysis, patients undergo surgery to make a connection to the blood using devices that fail in as little as one year costing Medicare $1 billion/year in new surgeries and high patient morbidity. We are providing a new solution for a long-lasting connection to the blood. Our device will reduce the number of surgeries required to fix or replace failed blood access devices in patients saving Medicare hundreds of millions of dollars per year and reducing dialysis patient morbidity.

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Published by: Mary Katherine O'Grady on Apr 27, 2011
Copyright:Attribution Non-commercial

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05/17/2012

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BACKGROUNDTHEVASCULARACCESSPROBLEM
In 2008 over 48,000 Americans with diabetes began treatment for end stage kidney disease(ESRD).
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This brought the total number of patients on kidney dialysis due to diabetes to over 202,000.
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 Although an extremely severe condition, ESRD can be managed by undergoing hemodialysis, whichreplaces the function of the kidneys by filtering blood through an external machine. This treatmentrequires an artificially created access point to the bloodstream by means of a surgical procedure.However, the failure rate and lifespan of current dialysis access options are grossly inadequate. The threecurrent options for dialysis access – arteriovenous (AV) fistulas, AV grafts, and central venous catheters – on average fail within six, three, and half a year, respectively. Once they fail, new accesses must becreated until the patient eventually runs out of access sites, costing Medicare $600 million each year andresulting in 18 percent of dialysis patient mortality.
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HEMOVA:APARADIGMSHIFTINDIALYSISACCESS
For the past 50 years, innovation in dialysis access has been focused on improving grafts andcatheters. However, they unavoidably lead to stenosis and infection. Hemova challenges the concept thata catheter or graft is the ideal form of dialysis access. The Hemova creates a paradigm shift away from themindset that stenosis and infection are unavoidable andthat innovation must mitigate or delay the effects of stenosis and infection. Instead, we seek to prevent their occurrence from the onset. In collaboration withclinicians from The Johns Hopkins Hospital, we havedeveloped a unique form of vascular access that greatlyextends the longevity and safety of access sites. TheHemova is a wholly implantable device that connectsto veins with naturally high flow rates, providingaccess by means of a subcutaneous port. This form of access avoids several problems that cause currentdevices to fail:1.
 
The Hemova reduces the risk of vessel wall injury from unnaturally high flows that lead tostenosis, a narrowing of the blood vessel, which causes 85 percent of graft and fistula failures andhundreds of thousands of intervention procedures each year.

1
DiabetesStatistics.AmericanDiabetesAssociation.Apr.25,2011.http://www.diabetes.org/diabetes-
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Swapnaetal.HeartDisease.2001.MARYO’GRADY,PETERLI,SHERRIHALL,SHISHIRANAGESH,THORATHORGILSDOTTIRTHEJOHNSHOPKINSUNIVERSITY
Fi 1.TheHemova
 
SavingDialysisPatients
 
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2.
 
The Hemova significantly reduces infection risk by having a completely subcutaneous port usingthe skin as a natural barrier to infection. Additionally, a novel cleaning system further reduces thechance of device infection.3.
 
The Hemova avoids the second leading cause of catheter failure – fibrin sheaths, reducing bloodflow through the indwelling catheter. By eliminating the indwelling catheter, the device canmaintain normal flow rates throughout its lifespan.Addressing the major causes of failure for current access sites gives the Hemova the potential to outlastcurrent devices by many years. This significantly reduces the healthcare burden and improves quality of life for hundreds of thousands of patients.
MARKETLANDSCAPE
Dialysis is a $60 billion industry and is growing at a rate of 5.9 percent each year.
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The ever-increasing diabetes population is one of the primary causes of kidney failure accounting for 44 percent of the dialysis population.
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Vascular access alone is a $1 billion market, which includes sales and placementof all catheters, grafts, and fistulas.
THEHEMOVA
The Hemova is a paradigm shift technology that eliminates inherent problems of other technologies by accessing veins that have naturally high flows. It is a fully implantable blood accessdevice placed under the skin and connected to a vein with naturally high flow rates such as the femoralvein in the leg (see Figure 1). Access to bloodflow is achieved when needles are puncturedinto the port.One of the most revolutionary aspectsof the device is its ability to be connecteddirectly to the vein, rather than using adamaging indwelling catheter. Implantationrequires only basic vascular surgery skills.During surgery, the device is sutured to thevessel at two points (Figure 2), and the port is placed just underneath the skin on the outside of the thigh. The port is ready for use in dialysisapproximately one week after the procedure.In addition, our novel valve mechanismallows for communication with the bloodstream only when a patient requires dialysis, thus avoidingclotting and infection issues. The valve is activated via a small needle that is inserted into the middle portto open and close the valves. Two larger needles, which connect to the dialysis machine, are then placedin the larger ports. When the dialysis machine is turned on, a portion of the blood flow is diverted into the

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MountaintopMedical.KaloramaInformation.April2009.Vein
 
Tri lePort
 
Tubing
 
Valve
 
Fi 2.TheHemovaattachedtoavein
 
Valve
 

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