WASHINGTON -- Abbott Vascular's Absorb GT1 resorbable stent has received FDA approval, .
It's the first bioresorbable stent product to win the agency's OK for coronary artery disease.
"The FDA's approval of the Absorb GT1 BVS offers a new treatment option for individuals who are candidates for angioplasty, but would prefer an absorbable device rather than a permanent metallic coronary stent," said , director of the division of cardiovascular devices at the FDA's Center for Devices and Radiological Health, in a statement.
The Absorb stent is made from a poly(L-lactide) plastic, also used in sutures and other current resorbable devices, that slowly degrades in vivo. The stent includes four tiny platinum bits that remain behind, allowing physicians to find its former location when necessary.
Primarily underlying the approval were results from a large trial, enrolling more than 2,000 patients, comparing Absorb with the conventional drug-eluting Xience stent over 1 year. Major adverse cardiac event counts were similar in the two arms. Stent thrombosis rates were about double with Absorb, at 1.5% versus 0.7% with the control stent, but the FDA still deemed the newer product approvable.
Poor outcomes have also been observed after scaffold placement in vessels under 2.5 mm. Thus, in small vessels, the label for the device “strongly” recommends quantitative coronary angiography or intravascular imaging to confirm appropriate vessel sizing.
In May, an FDA advisory committee voted overwhelmingly in favor of Absorb's approval.
The FDA noted that the Absorb stent should not be used in patients known to have hypersensivity or allergy to everolimus or to the poly(L-lactide) polymer, as well as in those with sensitivity to contrast agents or who cannot take anti-platelet drugs long-term.