đź“Š Evidence-Based Reference
Palindrome P Hemodialysis Catheter
Covidien Lp, Formerly Registered As Kendall
Summary: The Palindrome P Hemodialysis Catheter is a device used for vascular access in hemodialysis. It is primarily used when arteriovenous access is not feasible. Key evidence suggests improved catheter functionality and reduced complications.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K092205 ↗
Decision Date ?
October 30, 2009
Product Code ?
MSD Catheter, Hemodialysis, Implanted
Device Class ?
Class 2
Evidence ?
7 studies
The Palindrome P Hemodialysis Catheter was cleared by the FDA via the 510(k) pathway on October 30, 2009. It is manufactured by Covidien Lp and classified as a Class 2 device.
What It Is
The Palindrome P Hemodialysis Catheter is a tunneled, cuffed catheter designed for long-term vascular access in hemodialysis patients. It features a symmetric-tip design intended to enhance hemodynamic performance and reduce complications.
FDA-Cleared Indications
- Vascular access for hemodialysis.
- Long-term access in patients with end-stage renal disease or other conditions requiring hemodialysis.
- Use when an arteriovenous fistula or graft is not feasible or cannot provide adequate access.
Clinical Applications
- Tunneled central venous access for chronic hemodialysis.
- Hemodialysis access when an arteriovenous fistula or graft is unavailable or unsuitable.
- Hemodialysis access in patients who need a catheter while permanent arteriovenous access is created or matures.
- Hemodialysis access in selected patients who cannot undergo or maintain an arteriovenous fistula or graft.
Evidence Summary
The available literature includes randomized controlled trials and retrospective studies, with a total sample size exceeding 500 patients. Studies were conducted between 2009 and 2020, focusing on catheter performance and safety.
Reported Outcomes
Published studies report that the Palindrome catheter demonstrates improved catheter dysfunction-free survival rates compared to other designs. It is associated with effective blood flow rates and low recirculation, contributing to dialysis adequacy.
Safety Profile
Reported complications include infection and thrombus-related dysfunction, common to long-term catheter use. However, the Palindrome catheter's design aims to mitigate these risks, with some studies noting reduced infection rates.
Evidence Limitations
Evidence gaps include a lack of large-scale, long-term studies directly comparing the Palindrome catheter to newer designs. Further research is needed to confirm its advantages in diverse patient populations.
Practical Considerations
- The catheter is placed into a central vein, commonly the internal jugular vein, and tunneled under the skin to a chest exit site; femoral access may be used in selected situations.
- Placement is generally performed with ultrasound and fluoroscopic guidance using local anesthesia with or without moderate sedation.
- Available catheter configurations and lengths vary by model; the selected size must match the patient's anatomy, access site, and prescribed dialysis blood-flow requirements.
- The catheter should be used and locked according to the manufacturer's instructions and the dialysis center's protocol to reduce infection, thrombosis, air embolism, and dysfunction.
- MRI conditions depend on the exact catheter model and labeling. Verify the product-specific MRI status before scanning; do not assume that every Palindrome catheter has identical MRI conditions.
Linked Studies (7)
PubMed • 2020
Comparison of Clinical Performance of VectorFlow and Palindrome Symmetric-Tip Dialysis Catheters: A Multicenter, Randomized Trial.
Journal of vascular and interventional radiology : JVIR
RCT View Source →PubMed • 2016
A retrospective study of palindrome symmetrical-tip catheters for chronic hemodialysis access in China.
Renal failure
View Source →PubMed • 2014
Clinical application of long-term Palindrome catheter in hemodialysis patients.
Iranian journal of kidney diseases
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2013
Comparison of the palindrome vs. step-tip tunneled hemodialysis catheter: a prospective randomized trial.
Seminars in dialysis
RCT|prospective View Source →PubMed • 2013
Computational flow dynamics and preclinical assessment of a novel hemodialysis catheter.
Seminars in dialysis
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2006
Comparison of recirculation percentage of the palindrome catheter and standard hemodialysis catheters in a swine model.
Journal of vascular and interventional radiology : JVIR
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What are the clinical indications for Palindrome P Hemodialysis Catheter?
The catheter is indicated for long-term vascular access in hemodialysis patients, especially when arteriovenous access is not feasible.
What outcomes have been reported in clinical studies?
Studies report improved catheter dysfunction-free survival rates and effective blood flow rates, contributing to dialysis adequacy.
What complications have been reported?
Reported complications include infection and thrombus-related dysfunction, though the catheter's design 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.