Bio Nova International, a developer and manufacturer of collagen-based medical devices, announced on 6 July 2011 that its lead product – the biosynthetic vascular prosthesis, Omniflow II – will be studied in a randomised trial at the St George’s Healthcare NHS Trust in London, UK.
The investigator-initiated study “A multicentre, randomised, controlled, single blind clinical evaluation of the Omniflow II Vascular Prosthesis for arteriovenous haemodialysis access in the end stage renal disease recipient” will compare the performance of Omniflow II to that of currently available synthetic (PTFE) prostheses in dialysis patients.
The study has received final Ethics Committee approval and will enrol patients requiring long-term haemodialysis with a vascular prosthesis and for whom a native fistula is not possible. The primary endpoint is primary patency (flow through the prosthesis). Final results are expected in 2014.
Eric Chemla, chairman of the Division of Medicine and Cardiovascular Sciences at St George’s is the principal investigator, with patients to be recruited from St George’s Hospital.
Chemla said “Reliable access to the patient’s blood circulation is critically important in providing life-saving dialysis for patients with kidney failure. Blockages and infections are two key challenges faced in this area. Given the challenges in maintaining haemodialysis access, we are interested to examine the performance of the Omniflow II prosthesis, particularly in terms of its primary patency and resistance to infection.”
Hugh McCormack, chief executive officer at Bio Nova International, said “We are delighted that Dr Chemla and St George’s Hospital will be evaluating Omniflow II in a prospective randomised study. The outcomes will be a significant addition to the body of evidence regarding Omniflow II. The study is timely as kidney disease is a growing problem with over 2 million patients worldwide on dialysis.”