Abbott received FDA approval for Esprit resorbable scaffold

Abbott's Esprit resorbable scaffold system gained FDA approval for treating blocked arteries below the knee (BTK). While angioplasty is favored over vein bypass surgery for BTK arterial disease, restenosis poses a challenge, often requiring additional procedures, including limb removal. However, mechanical scaffolds used to keep arteries open can hinder vessel remodeling and pose late complication risks.

Esprit addresses these concerns by offering physical vessel support and releasing everolimus to reduce re-narrowing risk. Over three years, the scaffold resorbs, promoting vessel remodeling and decreasing late complication risks. In a trial involving 261 chronic limb-threatening ischemia (CLTI) patients, Esprit outperformed angioplasty. At one year, 26% of Esprit recipients experienced adverse events, compared to 66% with angioplasty, meeting the trial's primary endpoint.

With FDA approval ahead of schedule, analysts focus on Abbott's device sales growth potential.