📊 Evidence-Based Reference
Lifesite Hemodialysis Access System Cannula Exchange Model LHAS14120 LHCEK0000
Vasca
Summary: The LifeSite Hemodialysis Access System is a subcutaneous device for reliable vascular access in hemodialysis. Key evidence highlights its design to overcome limitations of traditional catheters.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K001633 ↗
Decision Date ?
August 24, 2000
Product Code ?
MSD Catheter, Hemodialysis, Implanted
Device Class ?
Class 2
Evidence ?
0 studies
The LifeSite Hemodialysis Access System was cleared by the FDA via the 510(k) pathway on August 24, 2000. 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 designed to provide immediate, reliable, high-flow vascular access for hemodialysis. It features a stainless steel and titanium valve implanted in a subcutaneous pocket, typically below the clavicle.
FDA-Cleared Indications
- Provides vascular access for hemodialysis.
- Provides an implanted hemodialysis access alternative for patients who require repeated dialysis access.
- Is intended for use as an implanted catheter system for hemodialysis access.
Clinical Applications
- Repeated percutaneous cannulation for hemodialysis treatments.
- High-flow vascular access through an implanted subcutaneous access device.
- Hemodialysis access in patients who are not appropriate candidates for, or have difficulty maintaining, conventional access routes such as an arteriovenous fistula or graft.
Evidence Summary
The available literature includes three studies published between 2000 and 2002. These studies encompass various methodologies, including in vitro evaluations and initial clinical results.
Reported Outcomes
Published studies report that the LifeSite System provides reliable, high-flow vascular access for hemodialysis. The device's design aims to reduce complications associated with traditional catheters, such as insufficient blood flow and thrombosis.
Safety Profile
Reported complications include potential blood trauma and hemolysis, as noted in in vitro evaluations. However, clinical studies have not extensively detailed adverse events.
Evidence Limitations
The evidence is limited by the small number of studies and lack of long-term data. Further research is needed to fully assess the safety profile and long-term outcomes of the LifeSite System.
Practical Considerations
- The system is implanted in a subcutaneous pocket, commonly in the upper chest below the clavicle, with catheter connections to a central vein.
- The device requires repeated needle access and sterile handling by trained dialysis personnel; infection prevention and assessment for malfunction are essential.
- The record identifies the LHAS14120 cannula-exchange model and LHCEK0000; exact component dimensions, catheter configuration, and compatibility should be confirmed in the current manufacturer labeling.
- MRI safety is not established by the information provided here. MRI eligibility should be confirmed from the current device labeling and the complete implanted system before scanning.
- Potential contraindications and complications include infection, thrombosis, bleeding, catheter malfunction, vessel injury, and inadequate blood flow; patient selection and implantation should follow the manufacturer's instructions.
Frequently Asked Questions
What are the clinical indications for LifeSite Hemodialysis Access System?
The LifeSite System is indicated for patients requiring frequent hemodialysis with reliable vascular access.
What outcomes have been reported in clinical studies?
Studies report reliable high-flow vascular access and reduced complications compared to traditional catheters.
What complications have been reported?
Reported complications include potential blood trauma and hemolysis, though clinical data on adverse events is limited.
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.