Overview

Pervasis is conducting its “V-HEALTH” (Vascular intimal Hyperplasia: Extending Arterial and venous patency, Limiting vascular Trauma, and inhibiting Hyperplasia while re-establishing vascular health) Phase I and II clinical trials in patients with End-Stage Renal Disease (ESRD) that require a permanent arteriovenous (AV) access for hemodialysis.

Vascugel® is the first therapy being developed to simultaneously improve outcomes for the two primary forms of surgical arteriovenous access, namely, AV grafts and AV fistulae. There are over 300,000 patients undergoing hemodialysis in the United States today, with an estimated annual growth rate of nearly 5% for new AV graft and AV fistula procedures performed each year.

About Vascular Access Failure

Vascular access failure is a major complication in providing care to patients on hemodialysis to treat ESRD. The prevalent ESRD population in the U.S. is expected to grow to 1.3 million by 2030. According to Medicare reports, total ESRD costs reached $20.1 billion in 2004 - with a total ESRD cost of $32.5 billion from all sources.

According to the United States Renal Data System (USRDS), the number of ESRD patients requiring hemodialysis in 2004 was over 300,000. Medicare data shows that vascular access complications account for up to 25 percent of all hemodialysis patient admissions, leading to about $1.5 billion in annual Medicare expenditures.

The majority of vascular access is achieved through the surgical creation of synthetic arteriovenous grafts (AVG) or arteriovenous fistula (AVF). A recent report analyzing USRDS data found an overall primary unassisted access patency rate of only 53% at 1 year. Vascular access failure is the single most important cause of morbidity in the hemodialysis population

[ back to top ]