Palette Life Sciences Gets FDA 510(k) Clearance for Barrigel Rectal Spacer

Palette Life Sciences has received the FDA’s 510(k) clearance for Barrigel rectal spacer, which separates the prostate from the rectum to protect it during radiation treatment for prostate cancer.

The clearance was based on positive results from a randomized trial using hypofractionated radiotherapy for treating prostate cancer with a rectal spacer. Barrigel is indicated for prostate cancer patients with early stage 1 to late-stage 3 disease.

The Barrigel spacer is made from non-animal stabilized hyaluronic acid, which is a “safe, proven” material, the company said.