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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 effectiveness in reducing uterine fibroid symptoms and their distribution characteristics in embolization models.
FDA Clearance Information
Pathway 510K
Number K022427 ↗
Decision Date August 22, 2002
Product Code HCG
Device Class Class 2
Evidence 0 studies
Contour SE Microspheres were cleared by the FDA through the 510(k) pathway on August 22, 2002. Manufactured by Boston Scientific, they are classified as Class 2 devices.
What It Is
Contour SE Microspheres are embolic agents designed for use in embolization procedures. They work by occluding blood vessels to restrict blood flow to targeted areas, such as tumors or fibroids.
Clinical Applications
These microspheres are commonly used in uterine artery embolization for the treatment of uterine fibroids and in other embolization procedures to manage abnormal blood flow or reduce tumor size.
Evidence Summary
The literature includes 11 studies, comprising various study types such as RCTs and systematic reviews, conducted between 2010 and 2025. These studies evaluate the physical properties, distribution characteristics, and clinical outcomes of embolization particles.
Reported Outcomes
Published studies report that Contour SE Microspheres are effective in reducing symptoms associated with uterine fibroids, such as menorrhagia and pelvic pain, with a significant reduction in uterine and fibroid volume. The studies also highlight their distribution characteristics in embolization models.
Safety Profile
Reported complications include a 3% complication rate during hospital stays for uterine artery embolization. Other studies have not detailed specific adverse events, indicating a need for further safety data.
Evidence Limitations
The evidence is limited by a lack of detailed safety outcomes and long-term efficacy data. Further research is needed to understand the full safety profile and to compare the effectiveness of Contour SE Microspheres with other embolic agents.
Frequently Asked Questions
What are the clinical indications for Contour SE Microspheres?
Contour SE Microspheres are indicated for use in embolization procedures, particularly for the treatment of uterine fibroids and other conditions requiring vascular occlusion.
What outcomes have been reported in clinical studies?
Clinical studies have reported effective symptom reduction in uterine fibroid cases, with significant decreases in uterine and fibroid volume.
What complications have been reported?
Reported complications include a 3% complication rate during hospital stays for uterine artery embolization, with limited additional safety data available.
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.