First absorbable stent for coronary disease is approved by the FDA

As the leading cause of premature death in the UK every year, and with over 2 million Britons living in its shadow, coronary heart disease is a familiar condition to many individuals, families and health care practitioners.

First absorbable stent for coronary disease is approved by the FDA

Image Credit

What is coronary heart disease?

This term refers to a condition where the arteries which carry blood to the heart are damaged by a lining of fatty deposits. In turn, this hampers blood circulation. The most popular long term treatment for this condition is an angioplasty.

The drawback of traditional treatment

This procedure involves a surgeon inserting a stent, which is a small mesh tube, into the affected artery to artificially widen it, and restore natural blood flow patterns. Unfortunately, in some cases scar tissue forms on the stent in the following years, undoing the progress made.

An exciting alternative?

The unveiling of a second option, a stent which is absorbed into the body over a three year period, means patients have the opportunity to choose between a permanent metal device and this new one.

The new device, known as the ‘Absorb GT1 Bioresorbable Vascular Scaffold System’ is made from poly(L-lactide). Over a three year post-surgery period, it gradually releases a drug called Everolimus to fight the formation of scar tissue, before being absorbed into the body.

Is it safe?

US Food and Drug Administration approval, (known as the FDA 510k clearance process), is required prior to launch. This acts as a safeguard, by assessing new products to confirm they are as safe and effective as comparable existing (legally sanctioned) equivalents. This process is traditionally quite long, but there are options to reduce the waiting time by employing a specialist company such as, who are accredited by the FDA to assess and reviews submissions on their behalf.

According to the key resource and leadership portal, Health Management, all ten members of the Circulatory System Devices panel agreed that the device was effective, and final approval was granted, after 9 of the 10 panel members voted that it was safe to use, and that the ‘risk/benefit profile’ was within adequate parameters.

No surgical procedure is without risk and side effects, but this device marks real progress in the treatment of coronary heart disease.