Cancer treatment using glass beads receives FDA approval
Photo | TMS Aerial Solutions
Boston Scientific's Marlborough headquarters
Marlborough medical device company Boston Scientific has received U.S. Food and Drug Administration approval for its TheraSphere Y-90 Glass Microspheres cancer treatment.
The treatment for hepatocellular carcinoma, the most common type of primary liver cancer, is comprised of millions of microscopic glass beads containing radioactive yttrium, which are delivered directly to liver tumors via catheter and result in minimal exposure to surrounding healthy tissue, according to Boston Scientific.
The FDA approval will expand treatment, which had previously been allowed under a humanitarian device exemption – an FDA classification which required institutional review board approval and limited the number of patients treated with the therapy per year.
HCC is one of the most prevalent cancers in the world and is most often treated through surgery, liver transplantation, chemotherapy or embolization. TheraSphere does not require hospitalization and is typically performed as an outpatient procedure in as little as an hour, according to Boston Scientific.
Approval of TheraSphere was based on results from a study finding 100% complete or partial patient response to TheraSphere and a 93% overall survival rate in patients with transplant or resection following treatment at three years.
WBJ Web Partners
Most Recent
Most Recent
0 Comments