FDA to review Abbott's one-of-a-kind dissolving medical implant to weigh its potential risks

On Tuesday, the United States Food and Drug Administration (FDA) is going to review Abbott's one-of-a-kind dissolving medical implant to evaluate its possible risks for the patients of heart attack and blood clot.

Abbott has requested FDA to approve its novel coronary stent, known as Absorb, as a substitute to metal stents, which has been in use for the treatment of narrowing arteries that generally result into heart attack or death.

Abbott's Absorb isn’t like traditional bare-metal stents that stay in place. Instead, it disappears within the body in a time span of three years after clearing fat-clogged arteries.

Dr. Dean Kereiakes of Christ Heart and Vascular Center said Absorb keeps the artery open for long enough, allowing it to heal, and then the implant fades away. Kereiakes said that it can bring back the artery to its usual, natural structure and function.

However, in a review posted previous week, federal regulators have raised queries regarding the medical device’s effectiveness and safety.

In the study submitted for review by the company, rates of cardiovascular complications were a little higher with Absorb as compared to Abbott's other drug-coated metal stent, known as Xience.

The FDA said that the chances of heart attack and stent-related blood clots were also more likely when Absorb was implanted into tinnier arteries.

The agency is going to consult outside experts about the data and after that, it will reach a decision over if the experimental implant should be given approval or not.

In October 2015, the company study reached on a conclusion that Absorb, made up of a plastic akin to dissolvable sutures or stitches, can be compared to Xience in terms of effectiveness and safety.