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bard utraverse small vessel pta balloon dilatation catheter
C.R. Bard
Summary: The Bard Utraverse Small Vessel PTA Balloon is a medical device used for percutaneous transluminal angioplasty (PTA) in small vessels. It is primarily used by interventional radiologists and vascular surgeons to treat peripheral artery disease.
FDA Clearance Information
Pathway
510K
Number
K010169 ↗
Decision Date
February 13, 2001
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Bard Utraverse Small Vessel PTA Balloon was cleared through the FDA 510(k) pathway on February 13, 2001. Manufactured by C.R. Bard, it is classified as a Class 2 medical device under product code DQY.
What It Is
The Bard Utraverse Small Vessel PTA Balloon is a catheter-based device designed for the dilation of small vessels. It works by inflating a balloon within the vessel to open up blockages and improve blood flow. This device is particularly useful in treating peripheral artery disease (PAD), where it helps to restore perfusion in narrowed or blocked arteries.
Clinical Applications
This device is commonly used in endovascular procedures to treat peripheral artery disease, especially in the femoropopliteal arteries. It is typically employed in interventional radiology and vascular surgery settings. Patients with atherosclerotic disease affecting small vessels are the primary candidates for this device, which helps to alleviate symptoms and prevent progression to more severe conditions.
Indications for Use
The FDA indications for this device include its use in percutaneous transluminal angioplasty to treat narrowed or blocked small vessels. It is intended for patients with peripheral artery disease, particularly in the lower extremities, to improve blood flow and reduce symptoms.
Practical Considerations
The Bard Utraverse Small Vessel PTA Balloon comes in various sizes to accommodate different vessel diameters. It is compatible with standard guidewires and catheters used in endovascular procedures. Clinicians should ensure proper sizing and inflation techniques to optimize outcomes and minimize complications.
Related Literature
The linked study, 'Drug-coated balloons to improve femoropopliteal artery patency: Rationale and design of the LEVANT 2 trial,' explored the use of drug-coated balloons in treating peripheral artery disease. The study highlighted the evolution of endovascular therapies and the role of PTA as a standard treatment. While drug-coated balloons showed promise, PTA remains a primary modality. Limitations include the need for more long-term data on outcomes.
Frequently Asked Questions
What is the Bard Utraverse Small Vessel PTA Balloon used for?
It is used for percutaneous transluminal angioplasty to open narrowed or blocked small vessels, particularly in patients with peripheral artery disease.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in endovascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in percutaneous transluminal angioplasty to treat narrowed or blocked small vessels in patients with peripheral artery disease.
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.