Dissolving medical products like stents and sutures are, in theory, a great idea. After all, if a patient can avoid the discomfort and risks that come with additional medical procedures or monitoring, then the benefits seem pretty clear.
The concept behind dissolving medical products is a simple one. After the devices have served their purpose, they simply dissolve over time and are absorbed by the body. If you’ve ever had any sort of oral surgery, there’s a good chance that your surgeon used dissolving sutures to close the incisions made in your gums.
Stents can also be of the dissolving variety, and medical device manufacturer Abbott Laboratories won FDA approval of Absorb; a dissolving vascular stent, in July of 2016. The idea is similar to dissolving sutures, only instead of being used to close surgical incisions, Absorb is placed in a patient’s arteries to help keep them open and avoid blockages. It is made of a material that dissolves over the course of about three years.
A study has emerged, however, that indicates that the use of the Absorb dissolving vascular stent could lead to a higher risk of adverse heart events when compared to a drug-coated stent after about two years of use.
When the study was conducted, the guidelines for Absorb implantation indicated that the device could be used in arteries that were actually too small or damaged to accommodate it. Because it is designed to dissolve over time, Absorb actually starts out larger that a static, drug-coated stent. It doesn’t appear that the larger size was taken into consideration in Absorb’s initial guidance. Researchers found that 19 percent of patients in their trial would not have qualified for Absorb after the new guidance was put in place.
As long as a medical professional is aware of, and following, the updated guidance on the use of Absorb, the differences between the dissolving stent and a drug-coated stent become minimal. According to the doctor who presented the results of this study at a meeting of the American College of Cardiology, the “difference between Absorb and Xience [the drug-coated stent] when they’re both implanted in properly-sized vessels with good procedural technique is likely to be quite modest and not clinically important.”
The FDA says that it has reached out to the medical community to inform them of the risks of Absorb.