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vipersphere pta balloon catheter
Cardiovascular Systems
Summary: The Vipersphere PTA Balloon Catheter is a medical device used for percutaneous transluminal angioplasty in venous stents. Key evidence highlights its clinical effectiveness and safety in various vascular interventions.
FDA Clearance Information
Pathway
510K
Number
K083139 ↗
Decision Date
November 25, 2008
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Vipersphere PTA Balloon Catheter was cleared by the FDA through the 510(k) pathway on November 25, 2008. It is manufactured by Cardiovascular Systems and classified as a Class 2 device.
What It Is
The Vipersphere PTA Balloon Catheter is designed for percutaneous transluminal angioplasty, a procedure to open narrowed or blocked blood vessels. It is primarily used in venous stenting procedures to improve blood flow.
Clinical Applications
Commonly used in the treatment of arteriovenous fistula stenosis and peripheral arterial disease, the Vipersphere PTA Balloon Catheter is applied in scenarios requiring vessel dilation to restore adequate blood circulation.
Evidence Summary
The literature includes 10 studies, comprising randomized controlled trials, prospective and retrospective analyses, and case series, conducted between 2023 and 2024. These studies evaluate the device's effectiveness and safety in vascular interventions.
Reported Outcomes
Published studies report that the Vipersphere PTA Balloon Catheter is effective in improving vessel patency in arteriovenous fistulae and peripheral arterial disease. Outcomes indicate significant improvements in blood flow and reduced restenosis rates in treated vessels.
Safety Profile
Reported complications include minor procedural risks such as vessel dissection and hematoma formation. Overall, the device demonstrates a favorable safety profile with low incidence of serious adverse events.
Evidence Limitations
Current evidence is limited by the short duration of follow-up in some studies and the variability in study designs. Further research is needed to establish long-term outcomes and to compare its efficacy with newer drug-coated balloon technologies.
Frequently Asked Questions
What are the clinical indications for Vipersphere PTA Balloon Catheter?
The device is indicated for use in percutaneous transluminal angioplasty procedures, particularly in venous stenting and treatment of arteriovenous fistula stenosis.
What outcomes have been reported in clinical studies?
Clinical studies have reported improved vessel patency and reduced restenosis rates, indicating effective restoration of blood flow in treated vessels.
What complications have been reported?
Safety data from studies indicate minor complications such as vessel dissection and hematoma, with a low incidence of serious adverse events.
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.