FDA says benefits outweigh risks in Abbott’s heart stent, Absorb
pharmafile | March 16, 2016 | News story | Research and Development, Sales and Marketing | Abbott, absorb, bioresorbable, coronary artery disease
An independent panel convened by the US Food and Drug Administration (FDA) has unanimously voted that the benefits of Absorb, which is Abbott’s fully bioresorbable drug eluting coronary stent, outweigh the risks.
The US-based health care company has developed this first-of-its-kind bioresorbable device for the treatment of coronary artery disease. Unlike most stents, which are made of metal, the Absorb stent dissolves completely after two to three years, once it has done its job of keeping a clogged artery open and promoting the healing of the artery. Metal stents, meanwhile, are a permanent feature in the patient’s life that restricts vessel motion by caging the artery over time.
The FDA’s panel reviewed the clinical data of the device available in more than 100 countries, and has been used in the treatment of more than 125,000 people so far. The panel voted 9 to 0, with one abstaining, that the benefits of Absorb outweighed the risks. It voted 9 to 1 that there was a reasonable assurance that the device was safe and voted 10 to 0 that there was a reasonable assurance that the device is efficacious.
Charles Simpson, chief medical officer and divisional vice president of medical affairs for Abbott’s vascular business, comments: “Fully dissolvable devices represent a transformative advance in the treatment of coronary artery blockages… We thank the members of the panel for their thorough review of the data, and we look forward to continuing discussions with the FDA on our submission for approval of this device in the US.”
Gregg W. Stone, MD, and chairman of the ABSORB clinical trial program, adds: “In multiple randomised clinical trials, the Absorb bioresorbable vascular scaffold has demonstrated comparable outcomes to the leading permanent metallic stent. As a first-in-kind device with novel properties, including complete dissolution and natural restoration of vessel function, this is a remarkable achievement.”
Abbott submitted pre-market approval for Absorb in mid-2015 to the FDA and, following this positive reception from the independent panel, a decision from the authority is expected later this year.
Sean Murray
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