Medical-device maker Guidant (GDT) said regulators for the European Union nations approved its new stent earlier than had been expected.
Approval by the European Union allows Guidant to market its Xience V stent system as a treatment for coronary artery disease. The stent is used to prop open clogged arteries and is coated with everolimus, a drug that prevents reclogging. The device will be ready for launch in the second quarter, Guidant said Monday.
"This early approval represents a significant milestone in Guidant's drug-eluting stent program and demonstrates our ongoing commitment to advancing the field of cardiovascular therapy through innovative solutions," said John Capek, president of Guidant's vascular intervention business.
Guidant, which also manufactures pacemakers and defibrillators, has been under fire since thousands of its devices were recalled last year. The Indianapolis-based company