Lombard Medical gains FDA clearance for expanded manufacturing facility in the UK

摘要

The US FDA has cleared the way for manufacturing to begin at Lombard Medical's new cleanroom operation in the UK. The larger facility will expand the medical technology company's global operating footprint and production capabilities to meet increased worldwide customer demand for the Aorfix endovascular stent graft for the treatment of Abdominal Aortic Aneurysms. The 10,000ft~2 expansion at the company's manufacturing site in Didcot, Oxfordshire, will accommodate more than 80 production staff. The expansion and regulatory clearance of our cleanroom facility is a key operational milestone for Lombard Medical as we focus on growing the commercial traction of Aorfix and building out the organisation for future growth,' said Chief Executive Simon Hubbert.