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The US Food and Drug Administration (FDA) has approved the first fully absorbable stent used to treat coronary artery disease.
With this approval, ‘Absorb’, the bio-absorbable or dissolvable stent from the US healthcare company Abbott, will now be available on its home-turf as well. Incidentally, Absorb has been available in India over the last three-and-a-half years.
About 18,000 Absorb stents are estimated to have been used in India and it remains to be seen whether the US development will impact the product use here. The product is priced a little less than ₹2lakh in India.
The usual practice for doctors is to look for US regulatory approvals on innovative products. With the approval, the local demand for the dissolvable stent may increase, said an industry insider. A stent is a wire-like mesh that is inserted into blood vessels to remove blockages (largely in the heart). And it has been at the heart of price control discussions in India involving medical devices.
Absorb is a breakthrough product in that it is absorbed into the body in about three years. The product further releases the drug everolimus to limit the growth of scar tissue, the FDA explained. (Scar tissue can form within the stent causing the artery to narrow again — called restenosis.)
The advantage of this product is that it does not leave any residual metal inside the blood vessel, says Nitish Naik, Professor of Cardiology at the All India Institute of Medical Sciences.
“We have been waiting for the FDA approval,” he says, adding that doctors prefer to use a new product only after they had enough evidence on it.
The product is useful for people who may need multiple stents or in young people who may require a heart procedure at a later date, he explains. At present, he says, “we use the product selectively depending on the patient profile”— if a person has a complicated block or is likely to need more procedures later — and so on.
The downside, he cautions, is that it is prone to blood clotting a little more than a regular stent. “So while it is uncommon, should it happen, it could be fatal,” he said. The product’s price is the other inhibitor, he said, adding that innovative technology is useful only if it is beneficial to patients. Especially when “we are the capital of heart diseases,” he adds.
Bio-resorbable What makes Absorb GT1 BVS (bio-resorbable vascular scaffold) dissolvable is that it is made from a biodegradable polymer called poly (L-lactide), similar to materials used in other types of absorbable medical devices such as sutures.
Once the product is absorbed, there are only four very small platinum markers embedded in the walls of the artery, which help cardiologists identify where Absorb was originally placed, the FDA explained.
The US regulatory agency evaluated data from a random trial of 2,008 patients, which compared the rate of major adverse cardiac events between the Absorb GT1 BVS and a drug-eluting metallic stent. While the cardiac adverse event rate was clinically comparable between the two groups after one year, the rate of blood clots forming within the devices stood at 1.54 percent for Absorb and 0.74 percent for the control group, the FDA said, listing out situations that could lead to adverse event situations, besides patients in whom such procedures were not to be done.
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