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 ?
510(k)
Number ?
K023023 ↗
Decision Date ?
December 4, 2003
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 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.
FDA-Cleared Indications
- Provides vascular access for hemodialysis.
- Provides repeated access to the vascular system in patients requiring hemodialysis.
- Used as an implanted hemodialysis access system when a subcutaneous access device is clinically appropriate.
Clinical Applications
- Repeated hemodialysis access through an implanted subcutaneous device.
- Hemodialysis access for patients who need frequent vascular access.
- Use as an alternative implanted access approach when conventional transcutaneous dialysis catheters are unsuitable 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.
Practical Considerations
- The system includes an implanted valve and associated cannula or access components; use requires the specific compatible insertion, exchange, and access kits.
- The device is placed in a subcutaneous pocket, commonly in the upper chest below the clavicle, with connection to suitable central venous circulation.
- Cannulation and maintenance require trained dialysis or vascular-access personnel and strict sterile technique to reduce infection and device damage.
- The FDA record provided does not establish MRI safety status. MRI conditions should be confirmed from the device labeling or manufacturer before scanning.
- Potential contraindications and complications include unsuitable venous anatomy, active infection, thrombosis, bleeding risk, malfunction, and inability to safely access or maintain the implanted system.
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.