📊 Evidence-Based Reference
Extra PTA Balloon Catheter with Embolic Capture Feature Proteus PTA Balloon Catheter with Embolic Capture Feature
Summary: The extra PTA balloon catheter with embolic capture feature by Angioslide is designed for percutaneous transluminal angioplasty. It is primarily used in venous stent procedures. Key evidence includes studies on its efficacy and safety.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K111750 ↗
Decision Date ?
July 21, 2011
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The extra PTA balloon catheter was cleared by the FDA through the 510(k) pathway on July 21, 2011. It is manufactured by Angioslide and classified as a Class 2 device.
What It Is
The extra PTA balloon catheter is a medical device used in percutaneous transluminal angioplasty (PTA) procedures. It features an embolic capture mechanism to aid in the treatment of stenosed vessels, particularly in venous stent applications.
FDA-Cleared Indications
- Percutaneous transluminal angioplasty of stenotic peripheral blood vessels.
- Dilation of stenoses in peripheral vessels when angioplasty is clinically indicated.
- Use with the embolic-capture feature to help collect embolic material generated during the procedure.
Clinical Applications
- Balloon angioplasty of narrowed peripheral arteries.
- Balloon dilation of stenoses associated with peripheral vascular disease.
- Angioplasty performed during or after placement of a peripheral vascular stent when additional vessel expansion is needed.
- Use in selected peripheral venous interventions when the catheter size, anatomy and labeling are appropriate.
Reported off-label uses
- Use in venous stent procedures to improve stent expansion or treat residual narrowing when the specific application is not included in the device labeling.
- Use in selected central venous or dialysis-access interventions when performed according to physician judgment and institutional protocols.
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 available literature includes four studies, comprising a mix of RCTs, prospective, and retrospective analyses. These studies span from 1986 to 2015, providing insights into the device's efficacy and safety.
Reported Outcomes
Published studies report that the extra PTA balloon catheter is effective in dilating stenosed vessels and improving blood flow in affected areas. The studies highlight its utility in treating conditions like subclavian steal syndrome and preventing restenosis.
Safety Profile
Reported complications include the potential for vessel injury and embolic events during procedures. However, the embolic capture feature is designed to mitigate such risks, enhancing the safety profile of the device.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of recent large-scale trials. Further research is needed to fully understand long-term outcomes and the device's performance in diverse patient populations.
Practical Considerations
- The available balloon diameters, lengths, shaft configuration and compatible guidewire or sheath sizes depend on the specific catheter model; confirm the current manufacturer instructions before use.
- The catheter is advanced through vascular access under fluoroscopic or other appropriate imaging guidance. Vessel diameter, lesion length, access route and the need for embolic capture must be assessed before treatment.
- Do not use the device if the catheter, balloon or packaging is damaged, or if the selected size is incompatible with the target vessel or access system.
- MRI safety depends on the exact device configuration and labeling. Confirm MR Safe, MR Conditional or MR Unsafe status in the current Angioslide instructions for use; do not assume MRI compatibility.
- Potential complications include vessel dissection or perforation, thrombosis, embolization, bleeding at the access site, infection, balloon rupture and the need for additional treatment.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for extra PTA balloon catheter?
The device is indicated for use in percutaneous transluminal angioplasty procedures, particularly in treating stenosed vessels in venous stent applications.
What outcomes have been reported in clinical studies?
Studies report effective dilation of stenosed vessels and improved blood flow, with applications in conditions like subclavian steal syndrome.
What complications have been reported?
Safety data indicate potential complications such as vessel injury and embolic events, though the device's embolic capture feature aims to reduce these risks.
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.