The Food and Drug Administration (FDA) has approved the Abbott Absorb, the first fully-dissolving heart stent in the US. Abbott’s Absorb GT1 is approved and available in over 100 countries outside the US and now has the go-ahead from the FDA.
The GT1 Bioresorbable Vascular Scaffold (BVS) System is made from pol(L-lactide), which is a biodegradable polymer that fully dissolves over three years. This leaves a patient’s artery free from a permanent implant except for tiny markers made of platinum placed during placement.
The approval comes after the FDA issued a caveat back in March about the dissolvable stent. The GT1 was compared to similar stents created by Abbott and test results showed a higher occurrence of thrombosis (blood clot), myocardial infarction (heart attack), and a possible link to these conditions based on the diameter of a vessel. Therefore, they recommended the GT1 for use with only larger vessels. A Senior analyst from Wells Fargo published a report following the FDA’s advisory council recommendations that the GT1 was not as great as Abbott’s other stent, the Xience, and due to the higher incidence of thrombosis, was not projected to be a major market shifter. However, despite the potential side effects, the GT1 is ideal for many patients.
The reason? The stent has no metal. According to medical experts, the stent allows for the treated artery to act naturally. No metal potentially reduces future blockages that are seen with permanent metallic stents. Most importantly, it allows for easier access for other treatment options.
The FDA also approved a stent from Boston Scientific. Their stent, the Synergy, is made from bioabsorbable polymer. It is not fully-dissolvable as the GT1, but it comes with drug coating and polymer that are absorbed by the body after about three months.
The next step for these stents will be to make sure that they’re manufactured in accordance with Good Manufacturing Practices and have several checks from their quality department. InstantGMP™ MD can help out with that. InstantGMP™ MD was designed for Medical Device companies that want to improve their quality unit or get a better handle on their manufacturing process. Check out the demo to learn more and sign up for your very own personalized demonstration.