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equalizer balloon catheter
Boston Scientific
Summary: The equalizer balloon catheter by Boston Scientific is used primarily in venous stent procedures. Key evidence highlights its efficacy in treating dysfunctional arteriovenous fistulae.
FDA Clearance Information
Pathway
510K
Number
K021721 ↗
Decision Date
June 20, 2002
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The equalizer balloon catheter was cleared by the FDA through the 510(k) pathway on June 20, 2002. It is manufactured by Boston Scientific and classified as a Class 2 device.
What It Is
The equalizer balloon catheter is a medical device designed for use in venous stent procedures. It functions by inflating within a vessel to help place or expand a stent, ensuring proper blood flow.
Clinical Applications
Commonly used in procedures involving venous stents, the equalizer balloon catheter is applied in scenarios requiring vessel dilation or stent placement, particularly in cases of dysfunctional arteriovenous fistulae.
Evidence Summary
The literature includes 10 studies, comprising randomized controlled trials and prospective analyses, conducted between 2023 and 2024. These studies evaluate the device's efficacy and safety in various clinical settings.
Reported Outcomes
Published studies report that the equalizer balloon catheter is effective in treating dysfunctional arteriovenous fistulae, with significant improvements in vessel patency. The device has shown promising results in maintaining blood flow and reducing restenosis rates.
Safety Profile
Reported complications include minor procedural discomfort and rare instances of vessel injury. Overall, the device is considered safe with a low incidence of serious adverse events.
Evidence Limitations
Current evidence is limited by small sample sizes and short follow-up periods. Further research is needed to evaluate long-term outcomes and compare the device's efficacy with alternative treatments.
Frequently Asked Questions
What are the clinical indications for equalizer balloon catheter?
The equalizer balloon catheter is indicated for use in venous stent procedures, particularly for treating dysfunctional arteriovenous fistulae.
What outcomes have been reported in clinical studies?
Clinical studies have reported improved vessel patency and reduced restenosis rates following the use of the equalizer balloon catheter.
What complications have been reported?
Safety data indicate minor procedural discomfort and rare instances of vessel injury as potential complications.
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.