Healthcare firm Abbott's one-year clinical results of Absorb III trial has reached its primary endpoint that there is no significant difference in efficacy when compared to the company's metallic drug eluting stent Xience.
Absorb III trial principal investigator Dr Dean Kereiakes said: "The Absorb data shows that there are no statistically significant one-year differences between Absorb and Xience, which is a major accomplishment given Xience’s strong performance as the current standard of care."
A primary endpoint of target lesion failure (TLF) of 7.8% for Absorb and 6.1% for Xience shows that both devices are comparable in treating people with coronary artery disease (CAD).
TLF is a composite of heart disease-related deaths, heart attacks attributed to the treated vessel, and repeat procedures within the treated lesion caused by ischemia.
Abott has enrolled around 2,000 patients with CAD in the randomized, single-blinded and controlled trial at 193 sites in the US.
The data from the trial will be used to get regulatory approval for the stent in the US.
Absorb is claimed to be the first device that works similar to the metallic stent through opening a blocked artery in the heart, restoring blood flow and providing relief from symptoms of
Abbott’s Absorb bioresorbable vascular scaffold (BVS) delivers Novartis Pharma’s everolimus, an anti-proliferative drug used in Xience coronary stent systems.
The firm received license for everolimus from Novartis for use on its drug eluting vascular devices.
Abbott chief medical officer Dr Charles Simonton said: "Results of the Absorb III pivotal trial show that Absorb is comparable to the best-in-class metallic stent."
In May this year, Abbott received CE mark approval for its Absorb stent system, Absorb GT1, to treat patients with heart disease.
Absorb is currently available in around 100 countries across the globe. The firm is planning to submit application for regulatory approval of Absorb in China.