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extra pta balloon catheter with embolic capture feature proteus pta balloon catheter with embolic capture feature
Angioslide
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
510K
Number
K111750 ↗
Decision Date
July 21, 2011
Product Code
DQY
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.
Clinical Applications
This device is commonly used in clinical scenarios involving the dilation of stenosed vessel segments, such as in the treatment of subclavian steal syndrome and other vascular conditions requiring PTA.
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.
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.