Venova Medical has announced enrolment of the first participants in the company’s VENOS-2 early feasibility study, assessing the Velocity percutaneous arteriovenous fistula (pAVF) system.
In a press release, the company says that the landmark represents a significant step forward in the development of the technology that is designed to enable a minimally invasive approach for the creation of an AV fistula for haemodialysis access.
The VENOS-2 study, performed under an investigational device exemption (IDE) granted by the US Food and Drug Administration (FDA), will enrol up to 25 subjects at up to six US Food and Drug Administration (FDA) clinical sites to evaluate the feasibility of the Velocity system.
Rashid Sharaf, an interventional nephrologist at the STAR Vascular Access Center in San Antonio (USA) who specialises in dialysis access management, performed the procedures.
“I am excited to participate in the VENOS-2 study and to evaluate the Velocity system as a next generation alternative for the creation of percutaneous AV fistulas,” said Sharaf. “Percutaneous AV fistulas offer a minimally invasive alternative to surgical approaches and provide a potentially better option for shorter time to fistula creation and maturation, which can lessen the exposure to, and risks associated with, haemodialysis catheters.”
The Velocity system is designed to create a pAVF in an efficient, minimally invasive procedure, to address patient and system barriers that often result in patients starting haemodialysis with central venous catheters. The Velocity implant is also designed to maximise the ability to use the fistula on haemodialysis soon after creation and to minimise the need for follow on procedures, thus addressing some of the major shortcomings with surgical AVFs.
“The launch of the VENOS-2 study is an important milestone in our mission to provide safer, more effective and more durable vascular access solutions for the haemodialysis population,” stated Erik van der Burg, CEO and co-founder of Venova Medical. “The outcomes of the VENOS-2 study will build on our first-in-human experience with the Velocity system and will be used to support our US pivotal study IDE. We are immensely grateful to Dr Sharaf and his team for their support in enrolling the first subjects of the VENOS-2 study.”
