FDA Green Lights Manufacturing at Lombard Medical’s New UK Facility
Oxfordshire, England, devicemaker Lombard Medical said Monday that the FDA has cleared the way for manufacturing to begin at its new cleanroom facility in the UK. The 10,000-square-foot facility, located in Didcot, Oxfordshire, is needed to meet demand for the Aorfix endovascular stent graft, the company said.
The increased manufacturing capacity expands Lombard’s global operating footprint, housing over 80 production employees at the Didcot site.
CEO Simon Hubbert said recent approvals and commercial launches of Aorfix in the U.S. and Japan — the two largest markets for abdominal aortic aneurysm repairs — spurred the need to increase manufacturing capacity. The graft was designed to solve problems associated with treating complex twisting anatomy, a frequent complication in advanced abdominal aortic aneurysms.
In addition to the FDA, the new UK site has been cleared by Japan’s Pharmaceuticals and Medical Devices Agency and by TUV Rheinland, an EU notified body. Lombard’s U.S. operations are based in Irvine, Calif. — Kellen Owings
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