Positive clinical trial results for dissolving heart stent

Abbott has announced positive one-year clinical results from the Absorb III trial

The trial compared the safety and effectiveness of Abbott's fully dissolving Absorb heart stent to Xience, Abbott's metallic drug eluting stent.

The trial was conducted at 193 sites, primarily in the United States, and enrolled about 2,000 people with coronary artery disease.

The results were published in The New England Journal of Medicine and showed that Absorb III met its primary endpoint and will be used to support regulatory approval of Absorb in the US.

Absorb is a device that functions like a permanent, metallic stent by opening a blocked artery in the heart, restoring blood flow and providing relief from symptoms of coronary artery disease (CAD).

However, unlike a metallic stent, which permanently restricts vessel movement and limits future treatment options, Absorb is made of a naturally dissolvable material that leaves behind a restored vessel in a natural state, free of a permanent implant.

Dean Kereiakes, medical director of The Christ Hospital Heart and Vascular Center and a principal investigator of Absorb III, said: "The Absorb III 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.

"Naturally dissolving heart stents are the next revolution in percutaneous coronary intervention, and Absorb is leading the way as an innovative option. Absorb does its job and then restores the vessel to its natural state over time, which cannot be achieved with a permanent drug eluting stent."       

Charles Simonton, chief medical officer and divisional vice president, Medical Affairs, vascular, Abbott, said: "Results of the Absorb III pivotal trial show that Absorb is comparable to the best-in-class metallic stent.

“However, because Absorb leaves nothing behind it may provide significant long-term benefits, such as a restored vessel in a natural state and renewed possibilities for people treated with Absorb."