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polarcath peripheral dilatation system
Cryo Vascular Systems
Summary: The PolarCath Peripheral Dilatation System is a cryoplasty device used primarily for treating peripheral vascular disease. Key evidence suggests its effectiveness in reducing restenosis and vessel recoil.
FDA Clearance Information
Pathway
510K
Number
K033622 ↗
Decision Date
February 10, 2004
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The PolarCath Peripheral Dilatation System was cleared through the FDA 510(k) pathway on February 10, 2004. It is manufactured by Cryo Vascular Systems and is classified as a Class 2 medical device.
What It Is
The PolarCath Peripheral Dilatation System is a cryoplasty device that uses nitrous oxide to inflate and cool a balloon to approximately -10 degrees Celsius. It is intended for the treatment of peripheral vascular disease by reducing restenosis and vessel recoil.
Clinical Applications
This device is commonly used in clinical scenarios involving peripheral vascular disease, particularly in the treatment of atherosclerotic lesions in the infrainguinal arteries. It is also used in cases where traditional angioplasty may not be effective.
Evidence Summary
The available literature includes six studies, with a mix of clinical trials and case studies, spanning from 2007 to 2012. These studies explore the device's safety and efficacy in various vascular conditions.
Reported Outcomes
Published studies report that the PolarCath Peripheral Dilatation System is effective in reducing restenosis and vessel recoil in peripheral vascular disease. It has shown promise in improving outcomes compared to traditional angioplasty techniques.
Safety Profile
Reported complications include potential procedural-related adverse events, though specific details are limited in the provided studies. Overall, the device is considered safe with a similar risk profile to other angioplasty techniques.
Evidence Limitations
The evidence is limited by the small number of studies and lack of large-scale randomized controlled trials. Further research is needed to fully understand long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for PolarCath Peripheral Dilatation System?
The device is indicated for the treatment of peripheral vascular disease, particularly in cases of atherosclerotic lesions in the infrainguinal arteries.
What outcomes have been reported in clinical studies?
Studies report effectiveness in reducing restenosis and vessel recoil, with improved outcomes compared to traditional angioplasty.
What complications have been reported?
Reported complications include procedural-related adverse events, though specific details are limited in the available studies.
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.