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introducer percutaneous
Novoste Puerto Ri
Summary: The introducer percutaneous by Novoste Puerto Ri is a medical device used primarily in embolization procedures. Key evidence highlights its application in percutaneous endoscopic gastrostomy and transapical structural procedures.
FDA Clearance Information
Pathway
510K
Number
K900658 ↗
Decision Date
August 23, 1990
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The introducer percutaneous was cleared by the FDA through the 510(k) pathway on August 23, 1990. It is manufactured by Novoste Puerto Ri and classified as a Class 2 device.
What It Is
The introducer percutaneous is a medical device designed to facilitate the insertion of catheters or other instruments into the body through a small incision. It is commonly used in procedures requiring vascular access or embolization.
Clinical Applications
This device is frequently used in clinical settings for procedures such as percutaneous endoscopic gastrostomy and transapical valve implantations. It provides a minimally invasive approach to access internal structures.
Evidence Summary
The literature includes 15 studies, comprising various study types such as RCTs and case series, published between 2020 and 2022. These studies explore the device's efficacy and safety in different clinical applications.
Reported Outcomes
Published studies report successful use of the introducer percutaneous in procedures like percutaneous endoscopic gastrostomy and transapical valve implantations. The device has shown effectiveness in facilitating these procedures with comparable success rates to alternative techniques.
Safety Profile
Reported complications include risks associated with embolization and procedural failures. However, studies generally indicate that the device is safe when used appropriately, with complications being rare and manageable.
Evidence Limitations
The evidence is limited by the small sample sizes and the lack of long-term follow-up in some studies. Further research is needed to establish comprehensive safety profiles and to explore additional clinical applications.
Frequently Asked Questions
What are the clinical indications for introducer percutaneous?
The device is indicated for use in procedures requiring vascular access or embolization, such as percutaneous endoscopic gastrostomy and transapical valve implantations.
What outcomes have been reported in clinical studies?
Studies have reported successful outcomes in facilitating procedures like percutaneous endoscopic gastrostomy, with effectiveness comparable to alternative techniques.
What complications have been reported?
Safety data from evidence indicate rare complications such as embolization risks and procedural failures, which are generally manageable.
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.