When arteriovenous (AV) fistulas fail or do not mature for use, dialysis patients have a trusted alternative in an AV graft - an implanted tube which directs blood from an artery to a vein, much as a fistula does – except the implanted vessel is usually made from a synthetic material such as Teflon®. Grafts can be expected to mature faster than fistulas and as a result can be a more quickly accessed for dialysis.

Unfortunately, AV grafts have experienced a long history of complications, mostly due to the unnatural diversion of blood from an artery to a vein 24/7, even though the graft is only needed for dialysis 9-12 hours per week. Grafts have traditionally been at a high risk of developing stenosis or narrowing of the vein immediately downstream from where the graft has been surgically connected to the vein. This narrowing frequently leads to clotting (thrombosis) which can close off the graft and make it unusable for dialysis. In addition, a condition known as “blood steal” often causes the fingers and hand below the graft to lose proper circulation. In worst case conditions, blood steal can lead to pain in the extremities below the graft - and even amputation where loss of circulation has occurred.

The “holy grail” of AV grafts would be to be able to selectively turn on the flow of blood to the graft when the patient needs vascular access for dialysis – and turn off the flow of blood when the patient is not in dialysis. This is the breakthrough offered by the CreatiVasc Hemoaccess Valve System® (HVS):

• Restores normal blood flow to the artery and vein at the AV graft site when the patient is not in dialysis.
  
• A patented valve system opens up the graft to blood circulation for dialysis.
  
• The HVS device can then close off the AV graft and flush/fill it with saline until the next dialysis session.
  

By having blood only flow through the graft during the time when the patient is in dialysis, a broad spectrum of current complications are addressed by the Hemoaccess Valve System® including:

• Significantly lower potential for clot formation
  
• Significant reduction/elimination of blood steal
  
• Elimination of excessive bleeding after dialysis has concluded
  

The CreatiVasc Hemoaccess Valve System® has undergone extensive testing to confirm its performance and reliability. The U.S. Food and Drug Administration (FDA) provided CreatiVasc with approval for human clinical trials which are now underway.

The Hemoaccess Valve System® offers a significant breakthrough to the multiple complications in one of the most common vascular access methods. The 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.

For more information about the Hemoaccess Valve System®, contact CreatiVasc today.