Merit Medical has announced winning de novo clearance for its Embosphere Microspheres to be used for prostatic artery embolization procedures as a treatment option for symptomatic enlarged prostate. The de novo classification means that this is the first product that can be used to embolize the prostatic artery without resorting to surgery.
The tiny spheres, made from acrylic co-polymer crosslinked with gelatin and available in seven sizes from about 40 μm to 1200 μm, are delivered via a microcatheter the internal diameter of which is actually narrower than the spheres themselves. The procedure is typically performed via a single puncture through the femoral artery, but can also be performed via the radial artery in the wrist. To pass through the microcatheter the spheres are squeezed to fit in and then naturally expand once delivered within the artery (see image on right), blocking the passage of blood through the vessel.
The Embosphere Microspheres have been previously used to treat symptomatic uterine fibroids, hypervascular tumors, and arteriovenous malformations.
Here’s a video presenting the Embosphere Microspheres
Via: Merit Medical…
Product page: Embosphere Microspheres…