CE Mark For CryoLife’s New HeRo® Graft

Tissue processing and device company CryoLife, Inc.,has gained a CE Mark for its new iteration HeRO (Hemodialysis Reliable Outflow) Graft system. The HeRO Graft is a proprietary graft-based solution for end-stage renal disease (ESRD) hemodialysis patients with limited access options and central venous stenosis.

Background

The first clinical cases of the new HeRO device in Europe are expected to be performed in July 2013. The surgeons performing these initial cases will establish the first HeRO Graft training center in Europe, which will support the Company’s controlled market introduction of the product during the second half of 2013, followed by a broader European launch in 2014.

The HeRO Graft received its initial FDA 510(k) clearance in 2008 and initial CE Mark approval in 2011. It is indicated for catheter dependent ESRD patients on long-term hemodialysis who have exhausted all other access options, such as AV fistulas and grafts (AVFs and AVGs).

The newly cleared version of CryoLife’s HeRO graft 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 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.

Company comments

“We have received positive feedback on the HeRO Graft from European physicians at medical meetings in Europe and the United States,” noted Steven G. Anderson, chairman, president and CEO of CryoLife. “We believe it will be well received in Europe because it is clinically proven to reduce infection rates by 69 percent as compared to tunneled dialysis catheters, which is a benefit for patients and government payors. Following the initial European cases, we will gradually train physicians and roll out the product to additional centers in order to ensure positive clinical outcomes ahead of a broader launch in 2014. We will also evaluate our early HeRO Graft experience in Europe, which we expect will further demonstrate the clinical utility of the product.”

Source: CryoLife, Inc., PR Newswire