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modification to contour se microspheres
Boston Scientific
Summary: Contour SE Microspheres are embolization devices used to occlude blood vessels in various medical procedures. They are primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K071634 ↗
Decision Date
July 12, 2007
Product Code
HCG
Device Class
Class 2
Evidence
0 studies
The Contour SE Microspheres were cleared via the FDA 510(k) pathway on July 12, 2007. Manufactured by Boston Scientific, this device is classified as Class 2 under product code HCG.
What It Is
Contour SE Microspheres are small, spherical embolic agents designed to occlude blood vessels. Made from biocompatible materials, they are injected into the vascular system to block blood flow to specific areas, often to treat tumors or vascular malformations. The microspheres come in various sizes to accommodate different vessel diameters and clinical needs.
Clinical Applications
These microspheres are commonly used in interventional radiology for procedures such as uterine fibroid embolization, treatment of hypervascular tumors, and arteriovenous malformations. They are typically employed in hospital settings, particularly in interventional suites, and are used by specialists trained in minimally invasive vascular procedures. The patient population includes those with benign or malignant vascular conditions requiring targeted embolization.
Indications for Use
The FDA indications for Contour SE Microspheres include use in embolization procedures to occlude blood vessels. This is particularly beneficial for patients with conditions like uterine fibroids or tumors that require reduced blood supply for treatment.
Practical Considerations
Contour SE Microspheres are available in a range of sizes to match the target vessel diameter. They are compatible with standard microcatheters used in embolization procedures. Proper technique involves careful selection of microsphere size and precise delivery to the target site to ensure effective occlusion.
Frequently Asked Questions
What is Contour SE Microspheres used for?
Contour SE Microspheres are used for embolization procedures to occlude blood vessels, often in the treatment of uterine fibroids and hypervascular tumors.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use Contour SE Microspheres in minimally invasive procedures.
What are the FDA-cleared indications?
The FDA-cleared indications include use in embolization procedures to occlude blood vessels, particularly for conditions requiring reduced blood supply.
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.