Abbott gets FDA approval for Absorb bioresorbable heart stent

6 July 2016 (Last Updated July 6th, 2016 18:30)

The US Food and Drug Administration has granted approval for Abbott's Absorb bioresorbable heart stent to treat coronary artery disease.

Absorb

The US Food and Drug Administration has granted approval for Abbott's Absorb bioresorbable heart stent to treat coronary artery disease.

Absorb is a fully dissolving stent which is composed of a naturally dissolving material similar to dissolving sutures.

The device is completely dissolved in approximately three years, after keeping the artery unclogged allowing the treated segment to heal.

Conventional metal stents are permanent implants which inhibit vessel motion for the life of the person treated.

Columbia University Medical Center, New York-Presbyterian Hospital cardiovascular research and education director and Absorb clinical trial programme chairman Gregg Stone said: "The Absorb bioresorbable scaffold represents a major advance in the treatment of coronary artery disease.

"This novel technology appeals to both physicians and patients alike because after treating the underlying blockage it is completely absorbed, leaving nothing behind.

"No metal means the treated artery can pulse and flex naturally as demands on the heart change with everyday activities.

"No metal may also reduce the potential of future blockages that occur with permanent metallic stents, and allows easier access to other treatment options should they prove necessary in the patient's future."

"No metal means the treated artery can pulse and flex naturally as demands on the heart change with everyday activities."

The Absorb bioresorbable stent displayed comparable short-term and mid-term outcomes to the leading metallic stent Abbott's Xience drug eluting stent in clinical trials.

In the pivotal Absorb III randomised clinical trial, approximately 2,000 US patients who were treated with the dissolving Absorb stent experienced comparable rates of specific adverse events in the intended patient population.

The outcome was judged on heart disease-related death, heart attacks attributed to the stented artery and repeat procedures at the treated lesion compared to patients who received the metallic Xience stent.

Abbot intends to introduce the Absorb device to hospitals in the US, starting with interventional cardiology centers that participated in Absorb clinical trials.


Image: Abbott's Absorb stent. Photo: courtesy of Abbott.