The FDA approved the first fully absorbable stent to treat coronary artery disease.
The US Food and Drug Administration (FDA) today approved the first fully absorbable drug-eluting stent.
The device Absorb GT1 Bioresorbable Vascular Scaffold System (BVS) is made by Abbott Vascular in Santa Clara, CA.
The stent offers a new option for patients with coronary artery disease, though it had slightly higher rates of undesirable side effects that the metallic stent used in comparison in clinical trials.
It elutes everolimus and is made from a biodegradable polymer known as poly(L-lactide) similar to that used in absorbable sutures, the FDA noted.
As it is absorbed, "the body gradually eliminates the presence of foreign material in the artery once the stent is no longer needed."
Four small platinum markers remain at the placement site to guide cardiologists later should they need to know where it was.
Data leading to its approval came from a randomized trial of 2,008 patients which compared the device to a drug-eluting metallic stent.
At one year the Absorb GT1 device patients had major adverse cardiac events at a rate of 7.8% compared to 6.1% of controls.
Those patients also had somewhat higher rates of blood clots forming within the device at 1.54% compared to 0.74% for controls.
It is contraindicated for patients with allergies to everolimus or the materials used in the device. Patients must be able to tolerate long term therapy with aspirin or other blood thinners.