CryoLife receives CE Mark for new HeRO Graft

CryoLife has announced that its HeRO (Hemodialysis Reliable Outflow) Graft system has been approved for sale in Europe.

The proprietary graft-based solution is intended for end-stage renal disease haemodialysis patients with limited access options and central venous stenosis – and has earned CE Mark accreditation ahead of a planned controlled market rollout later this year.

Having been approved in the US in 2008, the device has been implanted in more than 6,000 patients to date and is supported by nearly 130 published clinical studies and presentations.

The first HeRO Graft clinical cases in Europe are expected to be performed in July 2013, with the market opportunity for this device estimated at approximately $30 million (19.15 million pounds).

Steven Anderson, chairman, president and chief executive officer of CryoLife, said: "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."

Earlier this month, the firm's board of directors approved a ten percent increase in its quarterly cash dividend for the second quarter of 2013.