Boston Scientific Corporation (NYSE: BSX) has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the SpaceOAR™ Flex Hydrogel, designed to temporarily create space between the prostate and rectum to reduce the radiation dose delivered to the rectum during prostate cancer radiation therapy.
Prostate cancer is the second most common cancer diagnosis among men in the United States.1 Radiation therapy is a common treatment approach for prostate cancer, and rectal spacing is intended to minimize radiation exposure to the rectum during treatment.
Understanding the Benefits of SpaceOAR™ Flex Hydrogel in Prostate Cancer Treatment
Building on the established SpaceOAR™ Hydrogel platform, SpaceOAR Flex is designed to help protect quality of life by minimizing urinary, sexual and bowel side effects during prostate cancer radiation therapy. The hydrogel offers several features:
- Flexible hydrogel delivery provides physicians with the ability to pause delivery, assess placement and adjust hydrogel delivery in real time.
- Single-syringe delivery system enables physicians to place the entire hydrogel without changing syringes.
- Simplified device set-up is designed to reduce the number of steps in hydrogel device set-up when compared to SpaceOAR Hydrogel and SpaceOAR Vue™ Hydrogel.
“Rectal spacing has become an important tool for physicians seeking to limit radiation exposure to healthy tissue during prostate cancer treatment,” said Ronald Morton, M.D., chief medical officer, Urology, Boston Scientific. “SpaceOAR Flex Hydrogel builds on our experience in this category and provides physicians with another option based on their clinical and workflow needs.”
SpaceOAR Flex offers the same intended visibility benefits of SpaceOAR Vue. Designed to be visible on CT scans, SpaceOAR Flex can help enable accurate contouring of the prostate and rectum to support treatment planning. Visibility of SpaceOAR Flex on kV cone-beam CT is intended to aid physicians during prostate cancer treatment when positioning patients receiving image-guided radiotherapy.
Boston Scientific expects to begin a limited market release of SpaceOAR Flex in the United States later this year. SpaceOAR and SpaceOAR Vue will remain available as part of the company’s rectal spacing portfolio.