Therapeutic Applications

Arteriovenous (AV) Access for Hemodialysis

End-stage renal disease (ESRD) is an advanced and irreversible kidney disease, treated mainly by hemodialysis or liver transplantation. It is estimated that of the more than 500,000 patients with ESRD treated in the U.S. each year, approximately 70 percent of these patients receive hemodialysis.¹

Before patients can undergo hemodialysis, an arteriovenous (AV) access site must be created where blood can be removed, filtered and returned to the body. The majority of AV access is achieved through either an AV fistula, where the vein is connected directly to the artery, or an AV graft, where the vein and artery are connected to a tube.

Unfortunately, complications following AV access procedures are common and can include infection, blood clots, and narrowing of the vessel, which frequently lead to AV access failure. An estimated 60 percent of AV grafts fail after one year, requiring a procedure to restore flow or to create another AV access site.^2,3

Pervasis is developing Vascugel® as a breakthrough approach to reduce the number of AV access failures in hemodialysis patients. By placing Vascugel on the outside of the vessel at the AV access site during surgical intervention, the blood vessel immediately receives key regulatory signals that promote natural vessel repair, thereby enhancing and helping to regulate the healing response.

Vascugel has completed a successful Phase 2 clinical program in patients undergoing hemodialysis, and preparations for a Phase 3 registration trial are underway.

Learn more about Vascugel clinical trials.

Peripheral Arterial Disease

More than eight million Americans over the age of 50 have peripheral arterial disease (PAD), a serious condition in which plaque builds up in arteries, causing the restriction of blood flow. PAD has significant health implications, including high blood pressure, kidney dysfunction, reduced ability to walk, and increased risk for heart attack and stroke. PAD is most commonly seen in the legs, but can also be present in arteries within the arms, heart, head, kidneys, and stomach.

When lifestyle changes and medication are not enough, treatment often involves surgical intervention, such as angioplasty or stent placement. In the U.S., approximately 750,000 peripheral stent or angioplasty procedures occur annually. However, in many cases, the artery does not heal properly following intervention, which can lead to restenosis and cause serious complications, including limb amputation. It is estimated that more than 150,000 PAD-related amputations occur in the U.S. each year.⁴

Pervasis is developing PVS-10200 for the treatment of PAD. PVS-10200 is designed to be administered during angioplasty or stent placement to help reestablish healthy vasculature and has shown promise in preclinical studies.

Learn more about the PVS-10200 program.

¹ http://kidney.niddk.nih.gov/kudiseases/pubs/kustats/index.htm. Last accessed October 26, 2009.

² Dixon et al. DAC Study Group. Effect of dipyridamole plus aspirin on hemodialysis graft patency. N Engl J Med. 2009; 360: 2191-2201.

³ Hayashi et al. Vascular access for hemodialysis. Nat Clin Pract Nephrol. 2006; 2: 504-513.

⁴ The Sage Group Market Research Report (2009). Peripheral arterial disease: New pharmaceutical therapies to treat intermittent claudication symptoms, prevent ischemic events and to induce angiogenesis.