CryoLife Inc. (CRY), a tissue processing and medical device company focused on cardiac and vascular surgery, said it has received U.S. Food and Drug Administration or FDA 510(k) clearance for a next generation Hemodialysis Reliable Outflow or HeRO device. The HeRO device is the only subcutaneous AV access solution clinically proven to maintain long-term access for end-stage renal disease or ERSD hemodialysis patients with central venous stenosis. The company expects to introduce the next generation HeRO device in the fourth quarter of 2013, following scale up and validation of the manufacturing process.
The newly cleared version features an adaptor providing 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 about 2-3 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.
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