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Abbott's Absorb GT1 Is First FDA-Approved Absorbable Coronary Stent

 
• By Reed Miller

Following the near-unanimous advice of its advisory panel, the US FDA approved Abbott Laboratories’ Absorb GT1 everolimus-eluting biodegradable poly(L-lactide) scaffold, making it the first bioresorbable coronary stent commercially available in the US.

On July 5, the FDA approved Abbott Laboratories Inc.'s PMA for Absorb GT1 for improving coronary luminal diameter in patients with ischemic heart disease due to de novo native coronary artery lesions no longer than 24 mm with a reference vessel diameter between 2.5 mm and 3.75 mm. Absorb is also contraindicated for patients who cannot tolerate a regimen of post-procedural antiplatelet drugs and patients with hypersensitivity to everolimus or any of the stent's component materials.

As a condition of approval, Abbott has agreed to sponsor a prospective post-approval study enrolling up to 3,000 US patients....

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