The US Food and Drug Administration (FDA) has granted 510(k) approval to CryoLife's new Hemodialysis Reliable Outflow (HeRO) device.
The device, which the company claims, is the only subcutaneous AV access solution that maintains long-term access for end-stage renal disease (ERSD) hemodialysis patients with central venous stenosis.
The HeRO device features an adaptor that provides the option to pair its proprietary venous outflow component with other dialysis access grafts including early access arterial grafts.
CryoLife president and CEO chairman Steven Anderson said early access grafts eliminate the need for temporary dialysis catheters which are associated with increased risk of infection.
"Over the next several months we will work to optimize and validate the manufacturing processes for this next generation system, which includes scaling up our manufacturing supply chain," Anderson added.
The company is planning to launch the new HeRO device during the fourth quarter of 2013, following scale up and validation of the manufacturing process.
