CryoLife announced on 10 June 2013 achievement of a CE mark for the HeRO (Hemodialysis Reliable Outflow) Graft system produced at the company’s new manufacturing facility in Atlanta, USA. The HeRO Graft is a proprietary graft-based solution for end-stage renal disease haemodialysis patients with limited access options and central venous stenosis.
The first HeRO graft clinical cases in Europe are expected to be performed in July 2013. The surgeons performing these initial cases will establish the first HeRO Graft training centre 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 company estimates the European market opportunity for the HeRO graft to be approximately US$30 million.
“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% as compared to tunneled dialysis catheters, which is a benefit for patients and government payers. Following the initial European cases, we will gradually train physicians and roll out the product to additional centres 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.”
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 end-stage renal disease patients on long-term haemodialysis who have exhausted all other access options, such as arteriovenous fistulas and grafts. Prior to the introduction of the HeRO graft, the only option for these patients was access through percutaneous tunneled dialysis catheters, which are higher cost, have high infection rates, limit a patient’s lifestyle, and foster central venous stenosis, or narrowing. The HeRO graft overcomes the limitations of tunneled dialysis catheters by providing a completely subcutaneous graft that functions like a regular access graft during dialysis and provides superior blood flow and a 69% reduction in bacteremia (bacteria in the blood) compared with tunneled dialysis catheters. HeRO graft is the only subcutaneous arteriovenous access solution clinically proven to maintain long-term access for haemodialysis patients with central venous stenosis.
The HeRO graft has been implanted in more than 6,000 patients to date and is supported by nearly 130 published clinical studies and presentations. The product has established and expanding reimbursement rates in the USA, with reimbursement codes that are endorsed by the Society for Vascular Surgery and the American Medical Association. Hemosphere has six issued patents on the product in the USA, Europe and Japan and 12 patents pending.