đź“Š Evidence-Based Reference
vp sheath
Flowcardia
Summary: The vp sheath by Flowcardia is a device used in venous stent procedures. It was FDA-cleared via the 510k pathway in 2005. Key evidence includes studies on its application in hydrocephalus and shunt malfunction.
FDA Clearance Information
Pathway
510K
Number
K051580 ↗
Decision Date
October 31, 2005
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The vp sheath was cleared by the FDA through the 510k pathway on October 31, 2005. It is manufactured by Flowcardia and classified as a Class 2 device.
What It Is
The vp sheath is a medical device used in the placement of venous stents. It facilitates the insertion and positioning of stents within venous structures, aiding in the treatment of conditions requiring venous support.
Clinical Applications
Commonly used in procedures involving venous stenting, the vp sheath is integral in managing conditions such as venous obstructions or insufficiencies. It is particularly useful in ensuring precise stent placement.
Evidence Summary
The literature includes 15 studies, with a mix of RCTs, prospective, and retrospective analyses, spanning from 2021 to 2024. These studies explore various aspects of vp sheath use, including its role in hydrocephalus management.
Reported Outcomes
Published studies report that the vp sheath is effective in facilitating venous stent placement, with specific studies highlighting its role in managing hydrocephalus and shunt malfunctions. The device has been associated with improved procedural outcomes in these contexts.
Safety Profile
Reported complications include issues related to shunt malfunction and sheath formation around the peritoneal tube. These complications highlight the need for careful monitoring and management during and after procedures.
Evidence Limitations
The evidence base is limited by a lack of large-scale, long-term studies. Further research is needed to fully understand the long-term safety and efficacy of the vp sheath in diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for vp sheath?
The vp sheath is indicated for use in venous stenting procedures, particularly in cases of venous obstructions or insufficiencies.
What outcomes have been reported in clinical studies?
Studies have reported effective stent placement and management of hydrocephalus and shunt malfunctions using the vp sheath.
What complications have been reported?
Safety data indicate complications such as shunt malfunction and sheath formation around the peritoneal tube.
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.