Now a new device, called Virtue Sirolimus-Eluting Balloon (SEB), from Orchestra BioMed, a company based in New Hope, Pennsylvania, may soon be a new treatment option without having to leave anything behind. The SEB is an angioplasty balloon, and so is able to push plaque apart, but it also has tiny holes through which sirolimus microparticles can exit. These particles are conglomerations of sirolimus molecules, which get embedded into the vascular tissue. They slowly break down, releasing small amounts of the drug, which acts to prevent restenosis.
The Virtue balloon just received Breakthrough Device Designation from the FDA, which will help speed it through the regulatory process, potentially receiving final FDA approval real soon.
Here’s a video from Orchestra BioMed presenting its Virtue SEB:
Product page: Virtue Sirolimus-Eluting Balloon (SEB)…
Via: Orchestra BioMed…