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Contour Se Microspheres
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 ?
510(k)
Number ?
K022427 ↗
Decision Date ?
August 22, 2002
Product Code ?
HCG Device, Neurovascular Embolization
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.
FDA-Cleared Indications
- Embolization of blood vessels to reduce or stop blood flow in a selected vascular territory.
- Use in interventional procedures involving abnormal vascularity, tumors, or other target tissues when vessel occlusion is clinically indicated.
Clinical Applications
- Uterine artery embolization for symptomatic uterine fibroids.
- Targeted embolization of vessels supplying tumors or other hypervascular tissue when consistent with the device labeling.
- Embolization to control abnormal blood flow in a selected vascular territory.
Reported off-label uses
- Embolization of selected bleeding vessels in situations where particulate embolization is clinically appropriate.
- Embolization of selected vascular malformations or other hypervascular lesions.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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.
Practical Considerations
- Particle size selection depends on the target vessel diameter, vascular anatomy, desired level of occlusion, and risk of nontarget embolization.
- The microspheres are delivered through a compatible catheter under fluoroscopic or other appropriate imaging guidance; careful injection technique and continuous visualization are important.
- Contraindications and precautions include uncorrectable coagulopathy, severe vascular spasm, inability to safely catheterize the target vessel, and a high risk of reflux or nontarget embolization.
- MRI safety and conditions should be confirmed in the current manufacturer labeling because the device may remain in the body after embolization and labeling can vary by product configuration.
- Embolized particles are intended to provide durable vessel occlusion, but the clinical effect can change if vessels recanalize or collateral blood flow develops.
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.