Biodegradable arterial stent
In the USA, the first soluble stent was allowed to be used
Oleg Lischuk, N+1
The U.S. Food and Drug Administration has approved the use of the first soluble stent for the treatment of coronary heart disease (CHD), according to a press release from the department: FDA approves first absorbable stent for coronary artery disease.
The stent called Absorb GT1 Bioresorbable Vascular Scaffold System (BVS; bioabsorbable Vascular scaffold system) is made of poly-L-lactide, a biodegradable polymer similar to those from which suture material is produced. Dissolving, it slowly releases the drug everolimus, which suppresses the growth of scar tissue in the vascular wall.
The complete absorption of the Absorb GT1 BVS, developed and manufactured by Abbott Vascular, takes about three years. After that, four miniature platinum markers remain in the arterial wall so that doctors can further understand where the stent was installed.
Absorb GT1 BVS (photo by Abbott Vascular)
The conclusion of the expert council, on the basis of which the FDA decision was made, was made based on the results of randomized clinical trials involving 2008 patients. During the year after installation, the frequency of serious cardiovascular events with the use of Absorb GT1 BVS was 7.8 percent, which is clinically comparable to 6.1 percent with the use of a metal stent with a drug coating. The frequency of blood clots in the area of the device was 1.54 and 0.74 percent, respectively.
The use of soluble stents prevents such long-term side effects as insufficient flexibility of the vessel, the possibility of damage or acceleration of the atherosclerotic process in the area of the device. Two types of biodegradable stents are already used in Europe.
Absorb GT1 BVS is contraindicated in patients with hypersensitivity to any of the components of the stent or the contrast agent necessary for installation, as well as with contraindications for long-term use of drugs that prevent thrombosis.
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11.07.2016