đź“Š Evidence-Based Reference
lifesite hemodialysis access system cannula exchange kit insertion kit access cannila
Vasca
Summary: The LifeSite Hemodialysis Access System is a subcutaneous device designed for reliable vascular access in hemodialysis. It is FDA-cleared and supported by studies indicating its efficacy in providing high-flow access.
FDA Clearance Information
Pathway 510K
Number K023023 ↗
Decision Date December 4, 2003
Product Code MSD
Device Class Class 2
Evidence 0 studies
The LifeSite Hemodialysis Access System was cleared by the FDA via the 510(k) pathway on December 4, 2003. It is manufactured by Vasca and classified as a Class 2 device.
What It Is
The LifeSite Hemodialysis Access System is a fully implantable subcutaneous device that provides immediate, reliable, high-flow vascular access for hemodialysis. It consists of a stainless steel and titanium valve implanted in a subcutaneous tissue pocket, typically below the clavicle.
Clinical Applications
This device is commonly used in patients requiring frequent vascular access for hemodialysis. It is particularly beneficial in scenarios where traditional transcutaneous dialysis catheters are insufficient or problematic.
Evidence Summary
The available literature includes three studies published between 2000 and 2002. These studies encompass various methodologies, including prospective and retrospective analyses, focusing on the device's efficacy and safety.
Reported Outcomes
Published studies report that the LifeSite Hemodialysis Access System provides reliable high-flow vascular access for hemodialysis. The device's design aims to overcome limitations of existing transcutaneous catheters, offering a durable and biocompatible solution.
Safety Profile
Reported complications include issues related to blood trauma and thrombosis, as highlighted in the studies. However, the device's design aims to minimize these risks compared to traditional access methods.
Evidence Limitations
The current evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to fully assess long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for LifeSite Hemodialysis Access System?
The device is indicated for patients requiring frequent vascular access for hemodialysis, particularly when traditional methods are insufficient.
What outcomes have been reported in clinical studies?
Studies report reliable high-flow vascular access and improved durability compared to traditional catheters.
What complications have been reported?
Safety data indicate potential complications such as blood trauma and thrombosis, though the device aims to reduce these risks.
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.