A new type of heart stent that works like dissolving stitches, slowly going away after it has done its job, passed its first major test in a large study, doctors said Monday.
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Abbott, a leading healthcare company, announced positive one-year clinical results from the ABSORB III trial, which compared the safety and effectiveness of Abbott’s fully dissolving Absorb heart stent to Xience, Abbott’s market-leading, metallic drug eluting stent.
Stents are small tubes that are used to keep open different arteries cleared of any blockages. However, there are risks involved in this procedure as well as the stent can cause inflammation sometimes along with certain other problems that crop up over the years.
Abbott Laboratories has designed a heart stent that dissolves after performing its function, meaning that patients who need the medicine delivery system will not need to remove the stent.
The dissolving stent, which has a plastic that is similar to the kind used in sutures that dissolve, has been created to disappear completely within three years of implantation, which returns the blood vessel treated to its flexible, natural state.
The Absorb stent is made of degradable material that can stay in place and release medicine for nearly a year and then gradually dissolve over the period of two years.
The dissolving stent did not prove better, though, on several measures. Specifically, the target lesion failure rate (the primary endpoint) for Absorb and XIENCE was 7.8% and 6.1%, respectively (non-inferiority p 0.007).
“Because Absorb leaves nothing behind it may provide significant long-term benefits, such as a restored vessel in a natural state and renewed possibilities for people treated with Absorb”, said Dr. Charles Simonton, chief medical officer and divisional vice president for medical affairs at Abbott.
Of course it should be approvable: the device is already in use in more than 100 countries. Patients in the trial will be followed for at least five years. They are coated with drugs that help prevent reclogging. She was successfully implanted with a lattice-like stent made of polylactide, a material derived from corn starch, which is meant to go away in two years.
That contrasts with the Synergy stent just approved from Boston Scientific where the coating of polymer that delivers the drug disappears after time, leaving the metal stent.
Stone said it will take a few time for doctors to learn how to use the new device, which is a bit larger and softer than traditional metal stents.
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Finally, he concludes, “A lot of patients would much rather have a dissolving stent that returns arteries back to their normal condition”.
