Modification to Contour Se Microspheres
FDA Clearance Information
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
FDA-Cleared Indications
- Embolization of blood vessels when temporary or permanent vascular occlusion is clinically indicated.
- Use as an embolic material during catheter-based procedures to reduce or stop blood flow to a targeted vascular territory.
Clinical Applications
- Catheter-directed embolization of selected blood vessels.
- Occlusion of vessels supplying hypervascular lesions when consistent with the device labeling and treatment plan.
- Embolization of vascular territories in interventional radiology procedures.
Reported off-label uses
- Uterine fibroid embolization may be performed with microsphere embolic agents, but the specific indication should be confirmed in the current device labeling because use can vary by product and formulation.
- Embolization of selected arteriovenous malformations or other vascular lesions may be reported in clinical practice, but this is not necessarily an FDA-cleared indication for this specific device.
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.
Practical Considerations
- Microsphere size should be selected according to the target vessel diameter, flow characteristics, lesion, and risk of non-target embolization.
- The particles are delivered through a compatible catheter or microcatheter under fluoroscopic or other angiographic imaging guidance.
- Careful injection technique is required to avoid reflux, catheter blockage, unintended embolization, or ischemia of non-target tissue.
- MRI compatibility and artifact information should be checked in the current package labeling; embolization products may have different MRI conditions depending on their materials and delivery components.
- Contraindications and warnings may include uncorrectable coagulopathy, active infection at the treatment site, non-target arterial anatomy, or inability to catheterize the intended vessel; the operator should follow the current instructions for use.
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.