FDAnews Device Daily Bulletin

PATIENT RECEIVES IMPLANT IN FIRST-IN-HUMAN ABSORBABLE STENT STUDY

March 27, 2006
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A patient received the first implant earlier this month of an absorbable drug-eluting stent as part of a clinical trial conducted in Auckland City Hospital in New Zealand.

Developed by Bioabsorbable Vascular Solutions, a Guidant subsidiary, the bioabsorbable everolimus-eluting stent is designed to be fully absorbed by vascular tissue following the restoration of blood flow in patients with coronary artery disease. The trial will evaluate the safety of the stent for treating heart disease.

Guidant told FDAnews the patient is doing well and that this innovation could represent a "new frontier" in the treatment of heart disease. The patient, who is not being identified, was evaluated for 24 hours after the implant before the announcement was made, Nicole Osmer, manager of corporate communications for Guidant, said.

"Everything is fine [with the first patient]. We think doctors may actually prefer the stent [in the future]. But more importantly, it provides choices," she said.

Unlike metallic stents, bioabsorbable stents provide temporary structure and support to the affected vessel, and are then absorbed after the lesion has healed -- leaving a healthy vessel behind. Guidant's bioabsorbable stent is made of a polylactic acid (PLA) bioabsorbable polymer, which has been used in numerous medical applications since the 1960s including vascular, orthopedic and dental applications. It breaks down to lactic acid, a natural metabolite. ()a href="http://www.fdanews.com/ddl/33_12/" target=_blank>