BOSTON SCIENTIFIC INITIATES EUROPEAN LAUNCH OF SPACEOAR VUE™ HYDROGEL
The New Radiopaque Hydrogel Spacer is Visible on CT Scan, an Enhanced Option for Physicians Treating Patients Undergoing Radiation for Prostate Cancer
Paris, France. (09 June, 2021) – Boston Scientific Corporation (NYSE: BSX) today announced that it has initiated the European launch of SpaceOAR Vue™ Hydrogel. Like its predecessor, SpaceOAR Vue Hydrogel creates a temporary space between the prostate and the rectum, minimising the potential side effects of radiation therapy. 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 contra-indicated for MRI.
Prostate cancer is the most common cancer affecting men in Europe[i]. More than 400,000 new cases are diagnosed each year, and radiotherapy is a highly effective treatment.[ii] 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 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.”
The SpaceOAR Vue Hydrogel perirectal spacer offers the same clinical benefits as 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.[iii] 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.[iv] 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.[v]
“SpaceOAR Vue Hydrogel demonstrates our commitment to addressing unmet patient and physician needs with innovations that provide the best possible care,” said Miguel Aragon, vice president EMEA, Urology and Pelvic Health, Boston Scientific. “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.”
For more product and important safety information, please visit https://bostonscientific.eu/spaceoarvue.
About Boston Scientific
Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.eu and connect on Twitter and Facebook.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section
21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like “anticipate,” “expect,” “project,” “believe,” “plan,” “estimate,” “intend” and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding our product launches and product performance and impact. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.
Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; the closing and integration of acquisitions; intellectual property; litigation; financial market conditions; and future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. This cautionary statement is applicable to all forward-looking statements contained in this document.
+39 340 662 6364
+1 (508) 683 4479
[iii] Number of patients is based on units shipped and a Boston Scientific proprietary algorithm
[iv] Hamstra DA, Mariados N, Sylvester J, et al. Continued Benefit to Rectal Separation for Prostate Radiation Therapy: Final Results of a Phase III Trial. Int J Radiat Oncol Biol Phys. 2017;97(5):976-985.
[v] Hamstra DA, Mariados N, Sylvester J, et al. Sexual quality of life following prostate intensity modulated radiation therapy (IMRT) with a rectal/prostate spacer: Secondary analysis of a phase 3 trial. Pract Radiat Oncol. 2018;8(1):e7-e15.