Boston Scientific has initiated the European launch of its SpaceOAR Vue Hydrogel, an improvement on the FDA and CE-approved SpaceOAR Hydrogel used to prevent damage during radiotherapy on the prostate.
Like its predecessor, SpaceOAR Vue Hydrogel creates a temporary space between the prostate and the rectum, minimising the potential side effects of radiation therapy that can cause negative conditions like incontinence and erectile dysfunction.
But unlike the previous version, the new radiopaque version can be seen on computerised tomography (CT) scans, negating the need for physicians to include magnetic resonance imaging (MRI) in the treatment planning and accommodating patients who are contraindicated for an MRI scan.
“SpaceOAR Vue Hydrogel helps to reduce rectal dose in radiation planning, as well as increase clinician confidence in accurate contouring of the prostate and rectum,” explained Dr Clive Peedell, consultant clinical oncologist from the South Tees Hospitals NHS Trust in UK.
“The increased visibility of the gel also helps in the image-guided targeting of the radiotherapy delivery to the prostate, ensuring treatment accuracy and high-quality care for patients.”
Prostate cancer is the most common cancer affecting men in Europe, with more than 400,000 new cases diagnosed each year, and radiotherapy is a highly effective treatment.
However, due to the close proximity of the rectum to the prostate, prostate radiation therapy can cause unintended damage to the rectum, which can lead to fecal incontinence issues or other long-lasting side effects.
SpaceOAR Vue’s predecessor has been in use to reduce the rate of these side effects in NHS patients since the organisation struck a deal with Boston Scientific back in May 2019.
The SpaceOAR product became part of Boston Scientific’s male-focused offerings when the company that created it, Augmentix Inc, was acquired by the medical device giant in 2018 for $500m, with an agreement for an extra up to $100m for reaching sales-based milestones.
Traditional vs SpaceOAR Vue prostate hydrogel
The SpaceOAR Vue Hydrogel perirectal spacer offers the same clinical benefits as the traditional SpaceOAR Hydrogel, which was the first FDA-cleared and CE-Marked hydrogel perirectal spacer, and has been used in over 100,000 patients worldwide.
In a randomised clinical study of SpaceOAR Hydrogel, at median three years, more patients in the control group experienced declines in bowel (41% vs 14%) and urinary (30% vs 17%) quality of life than in the spacer group.
Additionally, more patients who were potent at baseline and treated with SpaceOAR were able to achieve erections sufficient for intercourse (66.7%, vs. 37.5%) than in the control group.
Boston Scientific vice president of urology and pelvic health Miguel Aragon said: “SpaceOAR Vue Hydrogel demonstrates our commitment to addressing unmet patient and physician needs with innovations that provide the best possible care.
“SpaceOAR Vue Hydrogel’s design may enable physicians to streamline the department’s procedural workflow by reducing the need for post-procedural MRI scan, while reducing radiation exposure for patients undergoing radiation therapy.” NS Medical Devices