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pta balloon catheter
Cook
Summary: The PTA balloon catheter by Cook is a device used primarily for percutaneous transluminal angioplasty. It is FDA 510k cleared and supported by 15 studies, highlighting its role in managing vascular stenosis.
FDA Clearance Information
Pathway 510K
Number K032931 ↗
Decision Date October 22, 2003
Product Code DQY
Device Class Class 2
Evidence 0 studies
The PTA balloon catheter by Cook was cleared via the FDA 510k pathway on October 22, 2003. It is classified as a Class 2 device under product code DQY.
What It Is
The PTA balloon catheter is a medical device designed for percutaneous transluminal angioplasty, a procedure to dilate narrowed or obstructed blood vessels. It is used to restore adequate blood flow in patients with vascular stenosis.
Clinical Applications
Commonly used in procedures to treat vascular stenosis, the PTA balloon catheter is employed in both arteriovenous access maintenance and peripheral artery disease interventions. It is particularly useful in managing thrombosed AV access.
Evidence Summary
The literature includes 15 studies, comprising randomized controlled trials, prospective and retrospective analyses, and case series, published between 2021 and 2023. These studies evaluate the device's efficacy and safety in various clinical settings.
Reported Outcomes
Published studies report that the PTA balloon catheter effectively manages vascular stenosis, particularly in arteriovenous fistula and peripheral artery disease. The device has shown efficacy in reducing procedure time and contrast use compared to standard methods.
Safety Profile
Reported complications include potential adverse events related to the angioplasty procedure itself, such as vessel injury or restenosis. However, specific safety data from the provided evidence is limited.
Evidence Limitations
The evidence is limited by the variability in study designs and small sample sizes in some cases. Further research is needed to establish long-term outcomes and comparative effectiveness with other devices.
Frequently Asked Questions
What are the clinical indications for PTA balloon catheter?
The PTA balloon catheter is indicated for use in percutaneous transluminal angioplasty to treat vascular stenosis, particularly in arteriovenous access and peripheral artery disease.
What outcomes have been reported in clinical studies?
Studies have reported effective management of vascular stenosis, with reduced procedure time and contrast use compared to standard methods.
What complications have been reported?
Reported complications include potential vessel injury or restenosis, though specific safety data from the evidence is limited.
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.