The United States Food and Drug Administration (FDA) on Tuesday will review Abbott's one-of-a-kind dissolving medical implant in order to weigh its potential risks to heart attack and blood clot patients.
Abbott is seeking approval from the FDA to sell its novel coronary stent called Absorb as an alternative to metal stents, which are currently used to treat narrowing arteries that often lead to heart attack or death.
Unlike traditional bare-metal stents that remain in place, Abbott's Absorb disappears into the body within three years after clearing fat-clogged arteries.
Dr. Dean Kereiakes of Christ Heart and Vascular Center said Absorb holds the artery open long enough for it to heal, and then the implant disappears.
"It can return the artery to its normal, natural structure and function," said Kereiakes.
Is Absorb Safe?
Federal regulators, however, have raised questions about the effectiveness and safety of the medical device in a review posted last week.
In the company study submitted for review, rates of cardiovascular complications were slightly higher with Absorb than with Abbott's other drug-coated metal stent called Xience.
Heart attack and stent-related blood clots were also more likely to happen when Absorb was implanted into smaller arteries, the FDA said.
The agency will consult outside experts regarding the data and discuss whether the experimental implant should be approved.
The company study concluded in October 2015 that Absorb, which is constructed out of a plastic similar to dissolving sutures or stitches, was comparable to Xience when it comes to effectiveness and safety.
The large clinical trial involved 2,000 patients who will be followed for at least five years following the implant. Researchers found that the rate of complications with Absorb was at 7.8 percent of patients, while the rate of complications with Xience was at 6.1 percent of patients.
The numerical difference was not statistically significant, but the FDA will ask advisers if it has any implications for the device's safety.
One Step Closer
Abbott spokesperson Jonathon Hamilton said the results of the study are from doctors using the new therapy for the first time.
"Consequently, we expect them to improve with time and experience," said Hamilton.
Absorb is already commercially available in more than 100 countries, and more than 125,000 patients have been treated with the dissolving heart stent.
A positive opinion from the FDA panel would bring the novel heart stent a step closer to the U.S. market, where about 850,000 patients receive stents every year.
If approved, Absorb would be competing with Xience, Medtronic Inc.'s Resolute stent, and Boston Scientific's Promus and Synergy stents.
