Galway medical device business wins FDA clearance

A Ballybrit based medical device company has received some good news for its export business. ArraVasc designs, manufactures, and markets innovative devices for interventional clinicians across the world. In August the business received notification of FDA clearance, which will allow export sales to the USA. 

ArraVasc’s facility in Ballybrit, which employs 40 people, is primarily a research and development hub and a manufacturing site.  The company’s  focus is primarily on peripheral vascular disease: by using its proven expertise in materials and product design, they are developing the Pirouette family of peripheral balloon catheters, which are often used to help patients with blockages in their arteries, commonly in the legs.

ArraVasc have been exporting the first Pirouette balloon catheters around the world – across Europe, South Africa and Brazil - and can now focus on the US market following the FDA clearance. Company CEO Jonathan Akehurst, is delighted with the move. “This is a major achievement for the business and we are very proud of the team here in Ballybrit that have worked hard to ensure this FDA clearance has occured.’’


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