Medtronic to manufacture new blood pressure tools in Ireland

Medical device giant waiting for hoped-for approval from FDA for new procedure partly developed in Ireland

Medtronic hopes a new treatment for high blood pressure, developed in part in Ireland, will become a new global standard of care.

The medical device giant, which employs more than 4,000 people here, says the device, which is currently under review by US regulators at the Food and Drug Administration (FDA) will be manufactured in Ireland, if approved.

“Hypertension [high blood pressure] is the number one contributor to death in the world,” Medtronic chief executive Geoff Martha said on a recent visit to Dublin. “And there are a lot of patients out there and the current standard of care [treatment with medication] they just don’t like. Patients don’t like to take those meds because of the side effects.

“This would be a one-time procedure, a day procedure, very minimally invasive. And we are very excited about that, so hopefully we get the approval for that and make it a global standard of care.

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The renal denervation procedure targets specific nerves near the kidneys that can become overactive and cause high blood pressure. The procedure works by delivering energy to these overactive nerves to decrease their activity.

The procedure, which is targeted at people who are unable to control blood pressure through lifestyle changes or medication alone, typically takes about an hour to perform.

However, the company will need to persuade the FDA to ignore the finding of its own expert independent panel which, on the casting vote of the chairman, decided in August that the risks of using the Symplicity Spyral renal denervation system outweighed its benefits.

The same committee did unanimously decide the procedure was safe with a majority backing its effectiveness. A decision is expected before the end of the year.

Manufacturing the device used in the surgery would be a boost for the group’s Irish workforce, given the huge size of the market for patients with difficult-to-treat high blood pressure.

Medtronic, the world’s largest medical device maker, became Irish domiciled after buying rival Covidien in a $43 billion deal in 2014, but operationally remains focused on the United States.

Mr Martha said Ireland’s stability, the quality of its education system and the pool of tech talent were some of the reasons the company continues to invest here. However, he noted the post-budget concern about health spending.

“If the healthcare system becomes a problem that becomes a problem for us as a large employer here, if not even more than that,” he said.

But he said he understood the economic challenges many countries are facing right now, adding: “We have got to lean into the reality that these healthcare budgets are going to be under pressure for years to come.”

He said that, for the first time, he considers it possible to offer better health outcomes and more access for people while “bending the cost curve”.

“Historically, we have had to make trade-offs between the three and now I am starting to see a path where you can improve all three with the right technology and, I think, at the same time governments are under pressure, provide better access and more innovation – to make sure your population has access to the latest technology and that that is not reserved only to the few but for everybody, but they have to do it on a budget.”

Dominic Coyle

Dominic Coyle

Dominic Coyle is Deputy Business Editor of The Irish Times