Implanting metal in our chests may be common, but it is always disconcerting. Every year, 600,000 new patients receive metal coronary stents to treat coronary artery blockage. Most of the time, those stents stay in a patient forever, long after its mission is complete. For the rest of their lives, patients must worry about complications resulting from the inhibition of natural vessel motion as well as future blood clots caused by the stents.
What if they could just disappear? This is the question researchers have been attempting to tackle for over 10 years. This past July, the first bioabsorbable stent was approved in the United States. The stent, which is made of a naturally dissolving polymer, widens the clogged artery for two years before it is absorbed into the body in a manner similar to dissolvable sutures. The disappearing stent leaves nothing behind, thus eliminating risk of inflammation that can lead to late-stent thrombosis and restenosis. The patient is then free to go off platelet inhibiting or blood thinning medication, thereby qualifying them for a larger range of medical interventions when needed.
Experts believe the market potential for bioabsorbable stents is high, with some estimates suggesting a $2 billion market in the next 6 years. While only one version has been FDA approved, there are at least 15 other ongoing bioabsorbable stent programs, all looking to take advantage of the huge market share, reflective of a seemingly endless patient population. While the approved stent is currently only used for patients with typical blockages, experts believe true disruption will take place as bioabsorbable stents are built to last longer and take on more complicated lesions. The market potential also extends to the peripheral arteries in the lower extremities, where traditional stents have had inferior results.
While the true potential for vanishing stents is yet to be seen, 2017 is the year the technology proves it won’t be disappearing from the market anytime soon.
Where Are They Now
In 2017, results of a three year clinical trial further evaluating the safety and efficacy of the first FDA approved bioabsorbable stent, showed a failure to demonstrate the theoretical advantages of the stent and uncovered a significantly higher rate of target vessel MI. In March 2017, the troubled stent was pulled from the European market and the FDA issued a safety alert for the device. The stent was pulled in the States by September, 2017. One known bioabsorbable stent development program has been terminated since this news.