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ultra-soft sv balloon dilatation catheter
Boston Scientific
Summary: The Ultra-Soft SV Balloon Dilatation Catheter is a medical device used for dilating stenotic segments in venous systems, primarily by interventional radiologists and vascular surgeons. It is designed for use in procedures requiring precise balloon dilatation.
FDA Clearance Information
Pathway
510K
Number
K050389 ↗
Decision Date
May 25, 2005
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Ultra-Soft SV Balloon Dilatation Catheter was cleared through the FDA 510k pathway on May 25, 2005. Manufactured by Boston Scientific, it is classified as a Class 2 device under product code DQY.
What It Is
The Ultra-Soft SV Balloon Dilatation Catheter is a specialized catheter designed for balloon angioplasty procedures. It features a soft, compliant balloon that can be inflated to dilate narrowed sections of veins, improving blood flow. The catheter is constructed to navigate the vascular system with minimal trauma, making it suitable for delicate procedures.
Clinical Applications
This catheter is commonly used in interventional radiology and vascular surgery settings for procedures such as percutaneous transluminal angioplasty (PTA). It is particularly useful in treating venous stenosis, often seen in patients with conditions like chronic venous insufficiency or post-thrombotic syndrome. The device is used in both inpatient and outpatient settings, catering to a wide range of adult patients.
Indications for Use
The FDA indications suggest that this catheter is intended for dilating narrowed venous segments. It is particularly relevant for patients with venous stenosis, where improved blood flow can alleviate symptoms and prevent complications.
Practical Considerations
The catheter is available in various sizes to accommodate different vessel diameters and lengths. It is compatible with standard guidewires and introducer sheaths. Clinicians should be aware of the balloon's compliance characteristics to avoid over-inflation and potential vessel damage.
Related Literature
The linked study investigated the use of percutaneous transluminal angioplasty and stenting in carotid arteries, highlighting early results. The study found that angioplasty with stenting could be a viable alternative to surgical options for carotid stenosis. However, the study's limitations include a small sample size and short follow-up period, which may affect the generalizability of the results.
Frequently Asked Questions
What is the Ultra-Soft SV Balloon Dilatation Catheter used for?
It is used for dilating narrowed segments in the venous system to improve blood flow.
What specialties typically use this device?
Interventional radiologists and vascular surgeons primarily use this device.
What are the FDA-cleared indications?
The device is indicated for dilating stenotic segments in the venous system, particularly in patients with venous stenosis.
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.