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www.fdanews.com/articles/85191-first-patient-enrolled-in-bioabsorbable-stent-trial

FIRST PATIENT ENROLLED IN BIOABSORBABLE STENT TRIAL

March 10, 2006

Guidant has enrolled the first patient in a clinical trial to evaluate the safety of a fully bioabsorbable everolimus-eluting stent platform for the treatment of coronary artery disease.

Guidant said the trial would study the safety of bioabsorbable drug-eluting stents, which are designed to be fully absorbed by the vascular tissue once the restoration of blood flow and drug-elution in patients with coronary artery disease is achieved.

The trial, known as ABSORB, is being conducted in humans for the first time, and would enroll up to 60 patients in Belgium, Denmark, France, New Zealand, Poland and the Netherlands. It is a non-randomized study, with an initial assessment of safety at six months and a follow-up period of five years.