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bard utaverse small vessel pta balloon dilatation catheter
C.R. Bard
Summary: The Bard Utaverse Small Vessel PTA Balloon is a catheter device used for percutaneous transluminal angioplasty (PTA) in small vessels. It's primarily used by interventional radiologists and vascular surgeons to treat peripheral artery disease.
FDA Clearance Information
Pathway
510K
Number
K012913 ↗
Decision Date
September 28, 2001
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Bard Utaverse Small Vessel PTA Balloon was cleared through the FDA 510(k) pathway on September 28, 2001, by C.R. Bard. It is a Class 2 medical device.
What It Is
The Bard Utaverse Small Vessel PTA Balloon is a catheter-based device designed for percutaneous transluminal angioplasty (PTA) procedures. It works by inflating a balloon within a narrowed or blocked blood vessel to restore blood flow. This device is particularly useful in small vessel interventions where precision and minimal invasiveness are crucial.
Clinical Applications
This device is commonly used in endovascular procedures to treat peripheral artery disease (PAD), particularly in the femoropopliteal arteries. It is utilized by interventional radiologists and vascular surgeons in hospital settings. The device is suitable for patients with atherosclerotic lesions in small vessels, aiming to improve blood flow and alleviate symptoms such as claudication.
Indications for Use
The Bard Utaverse Small Vessel PTA Balloon is indicated for use in patients with peripheral artery disease, specifically for dilating narrowed or blocked small blood vessels. It is intended to improve blood flow and reduce symptoms associated with PAD.
Practical Considerations
The device is available in various sizes to accommodate different vessel diameters. It is compatible with standard catheter systems and requires careful handling to avoid vessel damage. Proper technique is essential to ensure effective dilation and minimize complications.
Related Literature
The linked study, LEVANT 2, investigated the use of drug-coated balloons to improve patency in the femoropopliteal artery, a common site for PAD. The study highlighted the efficacy of endovascular therapies, including PTA, in restoring arterial perfusion. While drug-coated balloons showed promise, the study emphasized that PTA remains a standard treatment. Limitations included the need for long-term data on outcomes.
Frequently Asked Questions
What is the Bard Utaverse Small Vessel PTA Balloon used for?
It is used for percutaneous transluminal angioplasty (PTA) to treat narrowed or blocked small blood vessels, commonly in peripheral artery disease.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device in endovascular procedures.
What are the FDA-cleared indications?
The device is indicated for dilating narrowed or blocked small blood vessels in patients with peripheral artery disease to improve blood flow.
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.