CryoLife Announces First European Implant Of HeRO Graft
University of Leuven in Belgium first to use new solution for end-stage renal disease hemodialysis patients
ATLANTA, July 31, 2013 /PRNewswire/ -- CryoLife, Inc. (NYSE: CRY), a leading tissue processing and medical device company focused on cardiac and vascular surgery, announced today that the first European clinical implant of the Company's HeRO (Hemodialysis Reliable Outflow) Graft was performed at the University of Leuven Hospital in Belgium. The procedure was performed by Professor Inge Fourneau, a vascular surgeon, and Professor Sam Heye, an interventional radiologist.
Professor Fourneau and Professor Heye commented, "It is exciting to be the first hospital in Europe to offer the innovative benefits of the HeRO Graft to dialysis patients with end-stage renal disease in our local community. Based on the clinical results to-date in the U.S., we believe the HeRO Graft will reduce the rate of infection as compared to tunneled dialysis catheters and improve patient quality of life."
CryoLife received CE Mark for the HeRO Graft in June 2013. Professor Fourneau and Professor Heye will collaborate with the nephrologist team at the University of Leuven. CryoLife expects to conduct a controlled market introduction of the HeRO Graft during the second half of 2013, followed by a broader European launch in 2014.
Steven G. Anderson, chairman, president and CEO of CryoLife, said, "We are pleased to begin commercialization of the HeRO Graft in Europe and would like to thank Professor Fourneau and Professor Heye for performing the procedure. Over the remainder of the year we will train additional physicians on the procedure, which will support a broader launch in Europe beginning in 2014. We continue to believe the HeRO Graft represents a significant opportunity to provide a better dialysis access option for patients with end-stage renal disease and that it will be a growth driver for the Company."
About the HeRO Graft
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). Prior to the introduction of the HeRO Graft, the only option for these patients was access through percutaneous tunneled dialysis catheters (TDCs), 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 TDCs by providing a completely subcutaneous graft that functions like a regular access graft during dialysis and provides superior blood flow and a 69 percent reduction in bacteremia (bacteria in the blood) compared with TDCs. HeRO Graft is the only subcutaneous AV access solution clinically proven to maintain long-term access for hemodialysis 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 reimbursement rates in the U.S., with reimbursement codes that are endorsed by the Society for Vascular Surgery and the American Medical Association. For more information on the HeRO Graft, visit www.herograft.com. For additional information about CryoLife, visit the company's Web site: www.cryolife.com.
Statements made in this press release that look forward in time or that express management's beliefs, expectations or hopes are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements reflect the views of management at the time such statements are made and are subject to a number of risks, uncertainties, estimates, and assumptions that may cause actual results to differ materially from current expectations. These statements include those regarding our belief that HeRO Graft will be a growth driver for the Company. The impact of HeRO Graft upon our growth is subject to a number of risks and uncertainties, including that physicians and patients may not accept HeRO Graft as a viable treatment option, regulators could withdraw existing approvals or impose additional conditions for the use of HeRO Graft, future implants may not be successful or complications could arise subsequent to implant, economic conditions in the EU could impact the decision to utilize HeRO Graft based on its cost, competing products may prove more effective or cost less, and the recent inability of the Company to import tissue into the EU could impact decisions to utilize HeRO Graft. CryoLife is also subject to the general risks associated with our business, including the risk factors detailed in our Securities and Exchange Commission filings, including our Form 10-K for the year ended December 31, 2012 and subsequent filings. CryoLife does not undertake to update its forward-looking statements.
SOURCE CryoLife, Inc.
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