Anteris miracle heart valve ready for approval

Medical staff surround the first patient to receive the Anteris aortic valve. CEO Wayne Paterson is at left.

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  Chris Griffith

  Technology Reporter

  @chris_griffith

  
• 10:10PM February 2, 2022
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Australian firm Anteris Technologies will seek local approval of its breakthrough aortic heart valve that replaces open heart surgery with a simple insertion procedure.

The valve treats a condition called aortic stenosis, caused by a build-up of calcium that narrows the heart’s aortic valve opening. Untreated, the condition has a 50 per cent mortality rate within two years.

Instead of undergoing open heart surgery, a valve is inserted in the patient’s groin and threaded on a catheter through the thigh’s femoral artery to the heart. CEO and managing director Wayne Paterson said patients can remain conscious during the insertion process and be released within a day.

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Mr Paterson said the valve material had successfully obtained US Food and Drug Administration (FDA) approval and Anteris was seeking to commence the Australian regulatory approval process in 2023. “We may get fast tracked because of the clinical benefits of this product,” he said.

The company has just announced the completion of 30-day human trial results, saying its heart valve technology had met and exceeded the study’s objectives. Some 500 valve replacement operations had taken place so far.

Aortic stenosis is regarded as a common condition affecting about one in eight people over the age of 75.

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Mr Paterson said patients who presented with aortic stenosis were typically in the 60 to 80 age range. He said the condition can’t be treated with drugs alone.

Anteris CEO Wayne Paterson holds a catheter used for inserting the valve.

Anteris Technologies has now set-up a manufacturing plant in Perth. “This is all Australian technology,” Mr Paterson said. Engineering of the valve and tissue took place in Australia while the catheter had been engineered by US medical technology firms.

The company’s medical advisory board includes Dr Samir Kapadia, chairman of Cardiovascular Medicine at Cleveland Clinic, and US heart surgeon and researcher Dr Michael Reardon.

“There’s a $10bn market that we‘re in, there’s only two (other) players and we’re demonstrably better than both,” he said.

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He said the company’s “Adapt” patented material used in other surgery and now the valve had not resulted in a fresh calcium build up in patients followed for over 10 years.

Mr Paterson said he was negotiating for some Australian centres to be included in studies being undertaken for European and US regulators. “We think we‘ve got a pretty good chance because of the clinical superiority of this product.” An Australian doctor was being added to the medical advisory board.

Mr Paterson is an Australian who in pharmaceuticals worked for Roche in Australia, China and Korea before becoming director of marketing in the Asia Pacific region.

By 2007 he began working for Merck Serono, a biopharmaceuticals division of US giant Merck. His roles included president and CEO of its Japan operation from 2007-2010 and president of its Europe, Canada and Australian operations from 2011-2015.

He currently lives in Minneapolis, Minnesota, which he describes as the heartland of med tech globally. “We‘ve taken about three years to do what should have taken about six … because there’s so many med tech qualified people in this town.”

Anteris Technologies is registered in Brisbane.