The US Food and Drug Administration (FDA) has granted 510(k) clearance to CryoLife, Inc's next generation HeRO (Hemodialysis Reliable Outflow) device. The HeRO device is the only subcutaneous AV access solution clinically proven to maintain long-term access for end-stage renal disease (ERSD) hemodialysis patients with central venous stenosis.
CryoLife anticipates launching the next generation HeRO device during the fourth quarter of 2013 following scale up and validation of the manufacturing process.
The newly cleared version features an adaptor that provides the option to pair the HeRO device's proprietary venous outflow component with certain other available dialysis access grafts, including early access arterial grafts. The current generation includes a standard ePTFE graft, which requires the placement of a temporary dialysis catheter for approximately two to three weeks until the graft incorporates into the surrounding tissue and can be used for hemodialysis access. By design, early access grafts allow access in a matter of days, thus eliminating the need for an accompanying dialysis catheter.
"We are pleased to receive US FDA clearance for our next generation HeRO device, which will provide our customers with the option of using a standard or early access arterial graft in conjunction with the device's proprietary venous outflow component," noted Steven G Anderson, chairman, president and CEO of CryoLife. "Early access grafts eliminate the need for temporary dialysis catheters, which are associated with increased risk of infection, further enhancing the clinical benefits of the HeRO device. 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."