The FDA has granted 510K clearance to the hyaluronic acid rectal spacer Barrigel for use in patients with prostate cancer receiving radiotherapy, according to Palette Life Sciences, the developer of the technology.1
Barrigel, which is made from Non-Animal Stabilized Hyaluronic Acid (NASHA), is used to separate and increase the distance between the anterior rectal wall and the prostate when the patient is receiving radiotherapy. The intent of the technology is to decrease the amount of radiation received by the rectum, minimizing the potential long-term side effects of the treatment.
The FDA’s 510(k) clearance designation allows a company to market a medical device in the United States if the company can prove that its device is “substantially equivalent” to a device already being legally marketed.2
The FDA decision to award the clearance to Barrigel was based on data from the Barrigel Prostate Trial, a randomized controlled trial that used the rectal spacer when administering hypofractionated radiotherapy to patients with prostate cancer.
“The Barrigel Prostate Trial found that 98.5% of men who were treated with Barrigel met the primary endpoint of achieving at least a 25% reduction in radiation to the rectum. Patients who met the primary endpoint averaged an 85% reduction in radiation to the rectum, and Barrigel is proven superior in the reduction of acute and long-term Grade ≥2 GI toxicity at 3 and 6 months compared to control,” Martin King, MD, PhD assistant professor of Radiation Oncology at Harvard Medical School, Dana-Farber Cancer Institute, and Medical Director of the Barrigel Prostate Trial, stated in a news release.
“Radiation therapy is a cornerstone of prostate cancer treatment, but radiation exposure to surrounding healthy tissue, including the rectum, can profoundly impact the quality of life of these cancer survivors,” Peter F. Orio III, DO, MS, associate professor of Radiation Oncology at Harvard Medical School, stated in the release.
“There is a trend to use hypofractionated radiotherapy, which uses a shorter course of radiation to allow patients to complete their treatment in four to six weeks compared to conventionally fractionated radiotherapy, which takes almost nine weeks to complete. Quicker courses of radiation are more convenient to the patient and have been proven to provide equal cancer control rates, but can come at the cost of causing additional toxicity to patients, especially to the rectum, as a greater amount of radiation must be delivered each day in their course of therapy. Barrigel, injected between the prostate and the rectum, supports higher radiation doses while lowering the risk of toxicity to the rectum, resulting in less treatment-related side effects for these men,” added Orio.
Barrigel is contraindicated in patients with prostate cancer who have stage T4 disease. Regarding safety, Palette mentions on its company website that, “As with any injection procedure, there is a risk of infection. Potential procedure-related side effects can include pain at the injection site and a brief period of bleeding from the needle stick. Post-treatment side effects include mild to moderate sensation of rectal filling.”
Barrigel is currently approved for rectal spacing in Australia and Europe.
“We are extremely proud of today’s US FDA clearance of Barrigel and we look forward to working with urologists and radiation oncologists to help improve outcomes for the approximately 250,000 men in the United States diagnosed with prostate cancer each year, and 1.4 million men diagnosed globally,” Per G. Langö, chief executive officer and board director of Palette Life Sciences, stated in the release. “Data show that personalized medicine such as precision radiation therapy offers patients the greatest chance of survival and using Barrigel can decrease potential damage to healthy tissue during this treatment.”
1. Palette Life Sciences Announces FDA 510(k) Clearance for Barrigel® Rectal Spacer, Proven Safe and Effective at Minimizing the Harmful Long-Term Side Effects of Prostate Radiation Therapy. Published online June 9, 2022. Accessed June 15, 2022. https://bit.ly/3QrNuHV
2. 510(k) Clearances. US Food and Drug Administration. Accessed August 27, 2021. https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/510k-clearances