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contour se microspheres
Boston Scientific
Summary: Contour SE Microspheres are embolization microspheres used primarily for embolization procedures. Key evidence highlights their use in uterine artery embolization and other embolization contexts.
FDA Clearance Information
Pathway
510K
Number
K034068 ↗
Decision Date
March 26, 2004
Product Code
KRD
Device Class
Class 2
Evidence
0 studies
Contour SE Microspheres were cleared by the FDA via the 510(k) pathway on March 26, 2004. Manufactured by Boston Scientific, they are classified as Class 2 devices.
What It Is
Contour SE Microspheres are spherical embolization particles designed for use in embolization procedures. They are intended to occlude blood vessels to restrict blood flow to targeted areas, such as tumors or fibroids.
Clinical Applications
Commonly used in uterine artery embolization for the treatment of uterine fibroids, Contour SE Microspheres are also utilized in other embolization procedures to manage various vascular conditions.
Evidence Summary
The literature includes 11 studies, comprising systematic reviews, meta-analyses, and comparative trials, conducted between 2010 and 2025. These studies evaluate the efficacy and safety of embolization particles, including Contour SE Microspheres.
Reported Outcomes
Published studies report that Contour SE Microspheres are effective in reducing uterine volume and fibroid size in uterine artery embolization. They demonstrate a high success rate in managing symptoms associated with fibroids, such as menorrhagia and pelvic pain.
Safety Profile
Reported complications include a 3% complication rate during hospital stays for uterine artery embolization. Long-term efficacy is noted in 75% of cases at 5-7 years, with some studies indicating potential for secondary hysterectomy.
Evidence Limitations
Evidence gaps include limited understanding of the long-term effects of embolization with Contour SE Microspheres. Further research is needed to explore the comparative efficacy of different embolization particles and their long-term safety profiles.
Frequently Asked Questions
What are the clinical indications for Contour SE Microspheres?
Contour SE Microspheres are indicated for use in embolization procedures, such as uterine artery embolization for the treatment of uterine fibroids.
What outcomes have been reported in clinical studies?
Clinical studies report effective reduction in uterine and fibroid volume, with high success rates in symptom management for conditions like menorrhagia.
What complications have been reported?
Safety data from evidence indicate a 3% complication rate during hospital stays, with some cases requiring secondary hysterectomy in the long term.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.