麻豆传媒

The FDA approved the Esprit BTK everolimus-eluting scaffold system for chronic limb-threatening ischemia (CLTI) below the knee, on Monday.

This system represents the first drug-eluting resorbable scaffold with this indication, with balloon angioplasty alone as the standard of care for endovascular treatment of peripheral artery disease (PAD) below the knee for patients in the U.S.

"The FDA approval of Abbott's Esprit BTK system marks a significant milestone in our fight against peripheral artery disease below the knee and should usher in a new era of improved outcomes for people worldwide," said Sahil Parikh, MD, of Columbia University Irving Medical Center in New York City, who was a co-principal investigator for the Life-BTK trial, in the Abbott press release.

Esprit had demonstrated particularly good results for limb salvage and primary patency in Life-BTK. In this randomized trial of over 250 patients with CLTI and infrapopliteal artery disease, the composite efficacy endpoint was 74% in the Esprit scaffold group, a significant improvement over the 44% for controls receiving percutaneous transluminal angioplasty alone. The trial supported noninferiority for the device's safety as well.

CLTI, the most severe manifestation of PAD, requires frequent reintervention and often results in amputation.

The Esprit device is implanted via a catheter-based procedure and keeps a blockage open for approximately 3 years before disappearing, thereby avoiding the complications of permanent metal stents. Esprit features a backbone containing 100% poly-L-lactic acid and struts measuring 99 µm in thickness. Its coating is comprised of everolimus and bioresorbable poly(D,L-lactide).

In theory, the Esprit scaffold is expected to provide better durability to angioplasty for CLTI. The combination of a resorbable mechanical scaffold with an antiproliferative coating is thought to prevent acute lesion recoil, facilitate vessel remodeling, restore vasomotor function, help wound healing, and ultimately reduce reinterventions and adverse limb outcomes from restenosis.

Whether the long-term benefits pan out in clinical practice remains to be seen.

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