Sydney's Ventracor (ASX:VCR) has announced the first European implant of its VentrAssist device as part of its CE Mark Trial.
Surgeons at Papworth Hospital in the United Kingdom performed the procedure, according to the company. Ventracor CEO Colin Sutton said more European hospitals would now participate in the trial, including Rikshospitalet in Norway.
At a recent speech to the American Chamber of Commerce in Sydney, Sutton said the rate of patient recruitment for trials was slow because hospitals and cardiologists needed to be educated and brought on board.
He said he expected that the FDA would have to change its current "very demanding" protocol under which randomised trials were required for heart assist devices. "I think there will be an industry move to change this, it is currently too hard," he said.
He predicted a new generation of heart assist devices would include algorithms for physiological responsiveness into their design. "[They] will be the industry stanadard," he said.
Referring to the recent volatility of the company's share price, Sutton said it was one of the consequences of going through an IPO early: "One ends up with a daytrader share register."
However, he expects revenues to start flowing to Ventracor by the second half of this year, he said.
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