US approval of a new treatment for high blood pressure is a major boost for the Galway operation of medical device giant Medtronic where key parts of the new treatment are manufactured.
The Symplicity Spyral renal denervation system uses radio frequency energy delivered by catheter to nerves running from the kidney to the brain during a minimally invasive one-hour operation. The procedure calms the nerves that are seen as a significant player in raising blood pressure.
The device is then withdrawn, leaving nothing inside the patient’s body.
Jason Weidman, senior vice-president of Medtronic and head of its coronary and renal denervation division, said the potential of the device which has now been approved in 70 markets worldwide is enormous.
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“If you think about it from a worldwide perspective, hypertension [high blood pressure] is the largest contributor to death with one billion patients worldwide,” he said. “Less than 20 per cent of people have their blood pressure under control so there is a real need for new solutions.”
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As of now, the main treatment for high blood pressure are lifestyle changes and tablets.
“We all know lifestyle changes are difficult to do. Some people are successful but may people are not,” said Mr Weidman. “Drugs do work for hypertension but people do not consistently adhere to that regimen. About 50 per cent of people stop taking their medications after one year, at least in part.
“That’s the advantage of a procedure like this. It is a one-time procedure and you don’t have to take a pill every day.
He said that securing just 1 per cent of the patients who find themselves unable to stick with current treatment options “represents greater than a billion dollars of opportunity” for Medtronic. The company expects that the United States will be the focus for growing its market for the device over the next couple of years.
At present only one rival – a small independent US group called Recor Medical – offers a similar approach, so Medtronic, which is the world’s largest medical device group, is confident of its ability to lead the market.
Galway is responsible for manufacturing the worldwide supply of the device’s catheters – at least one of which is used in each procedure.
Medtronic chief executive, Geoff Martha, has said the group hopes the denervation device will become a global standard of care in the treatment of high blood pressure. Success on that scale would inevitably lead to further investment and expansion of the Galway business, which is the largest site in Medtronic’s worldwide coronary and renal denervation business.
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The Irish plant is already heavily involved in developing the next generation of the device, with a particular focus on process innovation to increase the use of automation in its manufacture.
Ronan Rogers, senior research and development director at the Galway operation, said the blood pressure treatment was a “huge opportunity” for Medtronic and its Galway plant.
“This is one of the biggest growth opportunities in Medtronic and probably one of the biggest growth opportunities across the whole medtech space globally,” he said.
The FDA approval is vindication for Medtronic’s decision 13 years ago to buy a US company called Ardian in an $800 million deal to access the technology at the heart of the device.
“There were a lot of people trying to get into this market back in 2014 and almost all of them gave up,” Mr Weidman said. “Medtronic had the fortitude to stay with it.”
