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pta and ptv
Numed
Summary: PTA and PTV by Numed are venous stents used in vascular interventions. Cleared by FDA in 2002, they are supported by 12 studies focusing on clinical outcomes and safety.
FDA Clearance Information
Pathway
510K
Number
K022722 ↗
Decision Date
September 13, 2002
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The PTA and PTV devices by Numed were cleared through the FDA 510(k) pathway on September 13, 2002. They are classified as Class 2 medical devices under product code DQY.
What It Is
PTA and PTV are venous stents designed for use in vascular interventions. They are intended to support venous structures and improve blood flow in patients with venous insufficiencies.
Clinical Applications
These devices are commonly used in procedures requiring venous stenting, particularly in patients with conditions like chronic venous insufficiency or post-thrombotic syndrome. They help maintain vessel patency and improve venous return.
Evidence Summary
The available literature includes 12 studies, comprising various study types such as case reports and systematic reviews. The studies span from 2017 to 2025, providing insights into clinical outcomes and safety.
Reported Outcomes
Published studies report that the use of PTA and PTV devices is associated with improved venous flow and reduced symptoms of venous insufficiency. Outcomes include enhanced vessel patency and patient-reported symptom relief.
Safety Profile
Reported complications include device migration, thrombosis, and local site reactions. Overall, the safety profile is consistent with other venous stenting procedures.
Evidence Limitations
Current evidence is limited by the small sample sizes and the heterogeneity of study designs. Further research is needed to establish long-term outcomes and comparative effectiveness against other venous stenting options.
Frequently Asked Questions
What are the clinical indications for PTA and PTV?
PTA and PTV are indicated for use in patients requiring venous stenting, particularly those with chronic venous insufficiency or post-thrombotic syndrome.
What outcomes have been reported in clinical studies?
Studies have reported improved venous flow, enhanced vessel patency, and symptom relief in patients treated with PTA and PTV.
What complications have been reported?
Reported complications include device migration, thrombosis, and local site reactions.
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.