Medtronic (NYSE: MDT) plans to manufacture parts of its renal denervation (RDN) technology in Ireland, The Irish Times reports.

But Medtronic’s Symplicity Spyral RDN system for treating hypertension has not yet been approved by the FDA following an advisory review panel that said the system’s risks outweighs its benefits.

Renal denervation could be a billion-dollar business for Medtronic, providing relief to millions of patients worldwide and potentially preventing heart attacks, strokes and other serious events tied to high blood pressure. Medtronic’s RDN system uses a radiofrequency energy ablation catheter to disrupt overactive nerves between the kidney and brain.

“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,” Medtronic Chair and CEO Geoff Martha told The Irish Times.

Medtronic already has a CE mark for the Symplicity Spyral RDN system, but it’s not clear whether the company would manufacture the system without FDA approval. A Medtronic spokesperson said she did not have more information to share in response to questions from Medical Design & Outsourcing.

Related: What is renal denervation? Medtronic Coronary and RDN President Jason Weidman explains

In August, the Circulatory Systems Devices Panel of the FDA’s Medical Devices Advisory Committee voted against recommending approval of Symplicity Spyral for hypertension under the proposed indications. One day earlier, the same panel supported approval of competing RDN technology developed by ReCor Medical.

Analysts who previously expected a favorable vote for Medtronic from the FDA review panel subsequently reversed course, saying FDA approval is unlikely. A decision from the FDA is expected by the end of this year.

But despite the negative vote, Medtronic could still receive FDA approval for its RDN system.

Medtronic has its operational headquarters in Fridley, Minnesota, but the company is officially headquartered in Dublin. Medtronic is the world’s largest medical device manufacturer according to Medical Design & Outsourcing‘s Medtech Big 100 ranking, and employs more than 4,000 people in Ireland.

Medtronic held its 2023 annual meeting of shareholders in Dublin last week.

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