The FDA granted 510(k) clearance for CryoLife‘s next-generation HeRO system in treatment of patients undergoing hemodialysis, the company announced.
The new HeRO device includes an adaptor so that it can connect CryoLife’s proprietary venous outflow to other dialysis grafts, including early access grafts, the company reported.
Early access grafts are designed to incorporate into surrounding tissue in a few days so that the patient does not need an accompanying dialysis catheter. The prior iteration of the HeRO system included a standard ePTFE graft, which takes longer to incorporate into the surrounding tissue and requires temporary dialysis catheter placement for around 2-3 weeks.
The Atlanta, Ga.-based tissue processing and medical device company is gearing up manufacturing for the planned launch in the 4th quarter of 2013, according to a company statement.
"We are pleased to receive 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," said CEO Steven Anderson in prepared remarks. "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.”
