The Zilver PTX is the world’s first FDA-approved drug-eluting stent for use in superficial femoral artery. It is designed to treat peripheral arterial disease — the buildup of fatty deposits within the lining of the arteries — which affects one-in-six people over the age of 55 in Ireland.
This fatty buildup accounts for 12% of cardiovascular disease hospital discharges in Ireland and represents 15% of bed days (over 100,000) annually.
While Cook Medical, which employs 700 people in Limerick, has not projected a jobs total, the new stent will be manufactured in its newly-built manufacturing facility.
Bill Doherty, Cook Medical’s executive vice-president EMEA, said: “US approval of the Zilver PTX stent means our Limerick plant will play an even more critical role in bringing Cook Medical’s technologies to patients.
As our Limerick operation moves to become the sole manufacturer of this device globally, we’re ensuring both the stable growth of Cook Ireland and enhancing Ireland’s reputation as a world-class cluster for medical devices.”
The company is investing up to €16.5m over the next four years with support from IDA Ireland. Construction has also commenced on a new R&D laboratory, beside Cook’s manufacturing site in Limerick.
The Zilver PTX stent has been used to treat more than 15,000 patients with peripheral arterial disease across Europe since 2009.
It is now available in more than 50 countries worldwide, including Japan, Taiwan, Australia and Brazil.
The US market is expected to be the world’s biggest for the device, and demand should increase dramatically with FDA’s approval to market the stent in the US.