HEMOACCESS VALVE SYSTEM
CAUTION: The Hemoaccess Valve System is in development and is not available for sale worldwide.
Brookhaven Vascular (formerly known as CreatiVasc Medical) is focusing technology innovations targeting End Stage Renal Disease (ESRD) which affects approximately 662,000 Americans and represents a $31 billion healthcare cost burden in the U.S1. Due to the lack of available kidneys for transplantation, approximately 468,000 ESRD patients are on dialysis because their kidneys are no longer able to work at a level needed to sustain life.1 While ESRD patients represent less than 1% of the Medicare population2, they account for 7% of Medicare spending.1 Vascular access has been frequently referred to as the Achilles heel of dialysis.3 Brookhaven Vascular is interested in fielding a significant technology development in this area.
Brookhaven Vascular is developing the latest generation of an innovative technology known as the Hemoaccess Valve System® (HVS). The first generation of the HVS concept was implanted in humans in an early-stage clinical trial and became one of the three inaugural technologies in the U.S. Food and Drug Administration’s (FDA) Innovation Pathway program in 2012.
The HVS device is designed to potentially address complications associated with arteriovenous (AV) grafts, one of the major methods used to connect renal disease patients to a dialysis machine for blood filtration. One study showed that in 328 patients, 77% of patients with an AV graft required invasive surgical intervention to maintain blood flow through their graft in the first 12 months after it is implanted4 and the surgical intervention is often repeated.5 Graft complications can include thrombosis (clotting)3, post-dialysis bleeding,5 and pseudoaneurysms.6 In addition, vascular access induced steal syndrome (“blood steal”) often causes the fingers and hand below the graft to lose adequate circulation which can lead to pain in the extremities below the graft - and even amputation where loss of circulation has occurred.7,8
It is believed that these complications may be associated with the unnatural diversion of blood from an artery to a vein via the AV graft for 24 hours a day when it is only needed for dialysis access 9-12 hours a week.
An AV graft places a burden on the heart since it requires high volumes of blood to be pumped through it to maintain its patency (flow). A normal brachial artery handles 27.8 gallons of blood daily while a graft requires 228.3 gallons to maintain the graft equal to over eight times the blood volume.8 Cardiovascular disease is major cause of death among ESRD patients.1
BROOKHAVEN VASCULAR TECHNOLOGY
The ideal AV graft hemodialysis process would be to selectively “turn on” blood flow into the AV graft when the patient needs vascular access for dialysis then “turn off” the flow of blood when the patient is not in dialysis, restoring normal blood flow to the artery and vein. This is the breakthrough that the Hemoaccess Valve System® (HVS) may offer. The HVS device will be implanted when a patient has a dialysis graft implanted for AV access. When the dialysis technician will magnetically activate the HVS device, valves at each end of the AV graft will open, allowing blood flow for dialysis. When dialysis is concluded, the AV graft is flushed with saline then the technician will use the device’s actuator to close the valves, restoring normal blood flow to the artery and vein. Sterile saline-heparin solution will remain in the graft between dialysis sessions. The Hemoaccess Valve System® is ONLY in development and NOT available for sale anywhere in the world at this time.
POTENTIAL CLINICAL BENEFITS
No clinical benefits have been proven with the use of the HVS. Some of the potential benefits are as follows:
Potential reduction of thrombosis (clotting) which require frequent interventional surgeries to keep AV grafts functioning for dialysis.4
Potential reduction of pseudoaneurysms which can lead to significant bleeding events after the patient has left the dialysis clinic.6
Potential reduction in the added workload on the heart to pump high rates of blood through the graft (as noted previously, 8x the normal blood flow).8
RECOGNITION AND A PLATFORM TECHNOLOGY
In addition to being selected as an FDA Innovation Pathway technology, the HVS device has won multiple awards including:
One of five winners (out of over 4,000 entries) in the History Channel’s INVENT NOW Innovation Awards.
The winner of the Deloitte InnoVision new technology award.
The HVS device may provide an innovative way to activate an implanted pump device without internal batteries or motors and without the use of needles to inject saline to activate the graft valves.
We believe this may have the potential to become a platform technology that has multiple applications for other medical applications. The HVS technology is protected by a broad portfolio of more than 14 issued and pending patents in the U.S. and around the world.
CAUTION: The Hemoaccess Valve System is ONLY in development and NOT available for sale anywhere in the world at this time.