FDA Considers Benefits and Risks of Absorb Stent
According to Reuters, Abbott’s coronary stent Absorb is currently undergoing FDA review in pursuit of approval to be marketed within the United States.
About the FDA Review
This past October a large clinical trial was released concluding that the Absorb stent, which is made from a plastic similar to that used in dissolving sutures, was comparable to market leader Xience in terms of its overall safety and effectiveness.
While the study did find Xience to be numerically better on a variety of secondary measures, the differences were determined to be statistically insignificant. However, the FDA has said they will ask the panel to address what risks may be associated with Absorb when used in smaller arteries due to the previously small sample portion.
Wells Fargo analyst Larry Biegelsen has said he expects the stent will receive a positive recommendation from the advisory panel and FDA approval later this year. He conservatively estimates the device will manage to capture 5% of market. If this approval does come through in the United States, Absorb would compete against Xience, Medtronic Plc’s Resolute, and Boston Scientific’s Synergy and Promus stents.
About the Stent
Abbott Laboratories is currently seeking approval to market their coronary stent, called Absorb, in the United States.
This device would serve as an alternative to the current metal stents used to prop open arteries, and is novel for its ability to dissolve within three years after implantation instead of remaining in place.
Absorb has already been implanted in more than 125,000 patients and is commercially available in 100 countries.