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percutaneous introducer kit
Teleflex
Summary: The percutaneous introducer kit by Teleflex is used for minimally invasive procedures such as percutaneous endoscopic gastrostomy. Key evidence suggests reduced peristomal infection rates with the introducer technique.
FDA Clearance Information
Pathway
510K
Number
K123974 ↗
Decision Date
February 21, 2013
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The percutaneous introducer kit by Teleflex was cleared by the FDA via the 510(k) pathway on February 21, 2013. It is classified as a Class 2 device under product code DYB.
What It Is
The percutaneous introducer kit is designed for minimally invasive access to body cavities, primarily used in procedures like percutaneous endoscopic gastrostomy. It facilitates the insertion of tubes or catheters through the skin into the gastrointestinal tract.
Clinical Applications
Commonly used in scenarios requiring nutritional support via gastrostomy, especially in patients with head and neck cancers or upper digestive tract stenosis. It is also employed in procedures requiring direct access to the gastrointestinal system.
Evidence Summary
The literature includes 13 studies, comprising RCTs, prospective, and retrospective analyses, published between 2012 and 2023. These studies evaluate the efficacy and safety of the introducer technique in various clinical settings.
Reported Outcomes
Published studies report that the introducer technique for percutaneous endoscopic gastrostomy reduces peristomal infection rates compared to conventional methods. The novel large-caliber introducer technique has shown utility and safety in patients with upper digestive tract stenosis.
Safety Profile
Reported complications include peristomal infections, which are reduced with the introducer technique. Other potential adverse events are related to the procedural aspects of gastrostomy, but recent advancements have mitigated these risks.
Evidence Limitations
The evidence is limited by the variability in study designs and patient populations. Further research is needed to standardize protocols and evaluate long-term outcomes across diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for percutaneous introducer kit?
The percutaneous introducer kit is indicated for procedures like percutaneous endoscopic gastrostomy, particularly in patients requiring long-term nutritional support.
What outcomes have been reported in clinical studies?
Studies have reported reduced peristomal infection rates and demonstrated the safety and utility of the introducer technique in patients with upper digestive tract stenosis.
What complications have been reported?
Reported complications include peristomal infections, which are less frequent with the introducer technique. Other procedural risks are present but have been reduced with recent advancements.
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.