Clinical Study of POSS-PCU Vascular Grafts for Vascular Access

A Clinical Investigation to Assess the Safety and Performance of POSS-PCU Small Diameter Grafts as Conduits in Arteriovenous (AV) Access

This study evaluates the safety and performance of a new vascular graft made of POSS-PCU as a vascular access conduit for haemodialysis. 30 patients requiring access for dialysis will be enrolled and monitored at regular intervals for 18 months.

Inclusion Criteria:

• Subjects requiring vascular access for haemodialysis

• Subjects with no suitable vein.

• Subjects aged 18 - 80 years old

• Subjects are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained

• Patients of child bearing potential, who are sexually active, must agree to the use of 2 highly effective forms of contraception throughout their participation in the study and for 6 months after completion of treatment:

  • Condom with spermicide.

AND 1 of the following:

• Oral contraceptive or hormonal therapy (e.g. hormone implants).
• Placement of an intra-uterine device.

Exclusion Criteria:

• Subjects with predicted short-term survival (less than 18 months) or poor prognosis (this will be on the discretion of the clinician in charge)
• Subjects with left ventricle ejection fraction (LVEF) <20% diagnosed on ECHO either pre-procedure or documented within the previous 3 months prior to consent.
• Pregnant or lactating
• Allergies to any constituents of the graft material
• Patients who are infected or colonized with Methicillin Resistant Staphylococcus Aureus (MRSA).