đź“Š Evidence-Based Reference
polarcath peripheral balloon catheter system
Cryo Vascular Systems
Summary: The PolarCath peripheral balloon catheter system is a cryoplasty device used primarily for treating peripheral arterial disease. Key evidence suggests it may reduce restenosis compared to conventional angioplasty.
FDA Clearance Information
Pathway
510K
Number
K042230 ↗
Decision Date
November 5, 2004
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The PolarCath peripheral balloon catheter system was cleared by the FDA via the 510(k) pathway on November 5, 2004. It is manufactured by Cryo Vascular Systems and is classified as a Class 2 device.
What It Is
The PolarCath peripheral balloon catheter system is a cryoplasty device designed to treat peripheral arterial disease by using cold temperatures to modify plaque and reduce restenosis. It is intended for use in peripheral arteries to improve blood flow.
Clinical Applications
Common clinical scenarios for the PolarCath system include treatment of peripheral arterial disease and venous stenoses, particularly in patients with atherosclerosis or those requiring dialysis access.
Evidence Summary
The available literature includes three studies, with types ranging from pilot studies to experimental models. The studies span from 2009 to 2016, focusing on the device's efficacy and safety.
Reported Outcomes
Published studies report that cryoplasty using the PolarCath system may reduce the incidence of restenosis in peripheral arteries compared to conventional angioplasty. One study in a rabbit model demonstrated mid-term efficacy in reducing arterial restenosis.
Safety Profile
Reported complications include typical risks associated with balloon catheter procedures, such as vessel injury. However, specific adverse events related to cryoplasty were not detailed in the provided studies.
Evidence Limitations
The evidence is limited by small sample sizes and the use of animal models, which may not fully extrapolate to human outcomes. Further research is needed to confirm long-term efficacy and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for PolarCath peripheral balloon catheter system?
The device is indicated for the treatment of peripheral arterial disease and venous stenoses, particularly in patients with atherosclerosis or those requiring dialysis access.
What outcomes have been reported in clinical studies?
Studies have reported that cryoplasty with the PolarCath system may reduce restenosis rates compared to conventional angioplasty, particularly in peripheral arteries.
What complications have been reported?
Safety data from evidence indicate typical procedural risks such as vessel injury, but specific cryoplasty-related adverse events were not detailed in the 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.