Marlborough, Mass.-based Boston Scientific has developed the SpaceOAR since its $600 million acquisition of Augmenix in September 2018. The absorbable polyethylene glycol hydrogel spacer won CE Mark approval in the European Union in 2010 and 510(k) clearance from the FDA in April 2015 and is designed for separating the prostate from the rectal wall during radiation treatment for prostate cancer.
Results from the study, published in the Journal of the American Medical Association, found that the safe prostate-rectum separation was sufficient enough to reduce v70 rectal irradiation and was associated with lower rectal toxicity and higher bowel quality of life in late follow-up.
The meta-analysis included randomized controlled trials and real-world results of 1,011 prostate cancer patients receiving radiotherapy. Researchers concluded that the analysis demonstrates that the placement of SpaceOAR before treatment is an effective preventative strategy for reducing radiation-induced rectal complications.
Men who received SpaceOAR prior to external beam radiotherapy received 66% less v70 rectal irradiation compared to controls (3.5% vs. 10.4%) and, after a median of 38 months post-procedure, late-grade rectal toxicity risk was reduced by 77% in SpaceOAR patients compared to controls (1.5% vs. 5.7%).