- The Food and Drug Administration has approved the first-ever dissolving stent, offering patients an alternative to permanent metal stents.
- Over three years, Abbott’s Absorb GT1 Bioresorbable Vascular Scaffold System is gradually absorbed by the body. The stent releases the drug everolimus to reduce scar tissue.
- The stent is made from a biodegradable plastic similar to that used in absorbable sutures.
Once the stent is fully resorbed, all that remains are four tiny platinum markers embedded in the artery wall to identify where the stent was placed.
“The Absorb bioresorbable scaffold represents a major advance in the treatment of coronary artery disease,” Gregg Stone, head of cardiovascular research at Columbia University Medical Center’s Center for Interventional Vascular Therapy and chair of the ABSORB clinical trial program, said in a release.
Part of its appeal is the artery can return to a pretreated state, adjusting its activity as demands on the heart change throughout the day. It may also reduce the rate of restenosis — a possible complication with metallic stents.
The approval was based on a randomized clinical trial of 2,008 patients, which showed Absorb to be clinically comparable to a drug-eluting metallic stent.
Abbott plans to roll out the device initially at interventional cardiology centers that participated in the trial, and then at hospitals across the U.S.
Absorb’s approval comes as Abbott is set to acquire St. Jude Medical for $25 billion in cash and stock. The proposed merger — announced earlier this year — would marry Abbott’s expertise in coronary intervention valve repair with St. Jude’s strength in heart failure devices, catheters and defibrillators.
Regulatory approvals of the deal are still pending.