Boston Scientific (NYSE:BSX) has issued an urgent field safety notice in Europe due to potential issues with its SpaceOAR systems.
Marlborough, Massachusetts-based Boston Scientific’s SpaceOAR system is an absorbable polyethylene glycol hydrogel spacer for separating the prostate from the rectal wall during radiation treatment for prostate cancer. The SpaceOAR Vue, the next-generation hydrogel spacer, offers enhanced visibility via CT scan.
Since the commercialization of SpaceOAR — which Boston Scientific has developed since its $600 million acquisition of Augmenix in September 2018 — embolism related to misplacement of the needle intravascularly has been a known adverse event included in the instructions for use (IFUs) for both the SpaceOAR and SpaceOAR Vue systems, according to the notice.
The company has recently received three reports of venous and arterial embolism to the abdominal viscera and lower extremities, occurring as a result of the inadvertent placement of SpaceOAR gel into a blood vessel and the subsequent migration of the hydrogel outside of the pelvis. No deaths have been reported in association with these events.
Boston Scientific issued the notice to raise awareness of embolism as an existing adverse event and provide new procedural instructions, warnings and precautions related to the potential issue. The company is not removing any SpaceOAR or SpaceOAR Vue devices from the field and the risk to patients associated with the device remains unchanged.
The company said the most serious adverse outcome resulting from an embolism due to vascular misplacement has been determined as life-threatening, but, as there have been no reported deaths associated with the reported events, based on the current available data, a life-threatening event or death resulting from embolism would be considered a rare event.
Boston Scientific investigated all reports that included patient harm and identified potential contributing factors that will be incorporated into the SpaceOAR and SpaceOAR Vue IFUs.