US: Abbot secures approval for drug to coronary artery disease

Abbott today announced the US Food and Drug Administration (FDA) approval of the XIENCE™ V Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease.

Manufactured in Clonmel, XIENCE V is a next-generation drug eluting stent system, which will be launched in the United States immediately.

"Abbott’s employees are driven by the constant goal of advancing medical science to help people live healthier lives. Our Abbott Vascular colleagues in Ireland have played, and continue to play, a significant role in the XIENCE V success story around the world," said John Capek, PhD, executive vice president, Medical Devices, Abbott.

He added: "The ability of our Clonmel facility to constantly meet and comply with stringent FDA regulations while maintaining the agility to respond to new developments and process improvements will be key factors to our success in introducing XIENCE V in the United States."

Abbott's Clonmel facility is one of two global manufacturing plants that have been manufacturing XIENCE V for markets outside the United States since 2006.

Working with the Temecula, California facility, the Clonmel facility helped develop the manufacturing process for XIENCE V, which included a team of Clonmel employees spending a number of months in Temecula to spearhead the transfer of technology and knowledge to Ireland. The Clonmel team has since worked closely with the Temecula team to refine and develop the robust manufacturing process.

The Abbott facility, which employs approximately 1,300 people in Clonmel, is expected to continue to play a role in supplying the United States, which is the largest market for drug eluting stents.

"Abbott's Clonmel facility has been instrumental in bringing this exciting medical device to the worldwide market," said Damian Halloran, divisional vice president, Abbott Vascular Operations in Ireland. "It is a tribute to our employees in Clonmel that Ireland has been selected to manufacture one of Abbott's flagship products and we are very proud to contribute to the global success of XIENCE V."