📊 Evidence-Based Reference
PTA Balloon Catheter
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 ?
510(k)
Number ?
K032931 ↗
Decision Date ?
October 22, 2003
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Used for percutaneous transluminal angioplasty of narrowed or obstructed peripheral blood vessels.
- Intended to restore or improve blood flow through stenotic peripheral vasculature.
- Use is governed by the specific catheter model's FDA-cleared labeling, including its indicated vessel sizes and treatment locations.
Clinical Applications
- Balloon angioplasty of stenotic peripheral arteries.
- Treatment of peripheral vascular narrowing that limits blood flow.
- Angioplasty of selected venous or dialysis-access lesions when permitted by the specific product labeling.
- Balloon dilation performed during an endovascular procedure under fluoroscopic imaging.
Reported off-label uses
- Balloon dilation of selected venous stenoses outside the device's labeled vascular territory.
- Angioplasty of thrombosed or dysfunctional arteriovenous dialysis access as part of an access-maintenance procedure.
- Balloon preparation or post-dilation of a lesion during selected peripheral or venous stent procedures.
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.
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.
Practical Considerations
- Available balloon diameters, lengths, shaft configurations and rated burst pressures vary by model; select the catheter for the target vessel and lesion.
- The catheter must be compatible with the guidewire, introducer sheath and contrast-injection system specified in its labeling.
- Use fluoroscopic or other appropriate imaging guidance, and inflate the balloon only with the recommended contrast-saline mixture and within labeled pressure limits.
- Contraindications and precautions include inability to cross the lesion, severe vessel tortuosity, uncorrected coagulation problems, contrast allergy or significant renal impairment when contrast is required.
- MRI safety depends on the exact catheter model and whether it remains in the patient; check the current manufacturer labeling before MRI. Most angioplasty catheters are single-use devices and are removed after the procedure.
Procedures that use this device
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.