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percutaneous introducer kit
Cormed, Inc., Sub. C.R.Bard
Summary: The percutaneous introducer kit by Cormed, Inc. is a device used primarily for vascular access and embolization procedures. Key evidence highlights its utility in reducing infection rates during percutaneous endoscopic gastrostomy.
FDA Clearance Information
Pathway
510K
Number
K860432 ↗
Decision Date
March 31, 1986
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The percutaneous introducer kit was cleared by the FDA via the 510(k) pathway on March 31, 1986. It is manufactured by Cormed, Inc., a subsidiary of C.R. Bard, and is classified as a Class 2 medical device.
What It Is
The percutaneous introducer kit is designed to facilitate the insertion of catheters or other devices into the vascular system. It is commonly used in procedures requiring vascular access, such as embolization or gastrostomy.
Clinical Applications
This device is frequently used in clinical settings for procedures like percutaneous endoscopic gastrostomy, where it aids in the safe and effective placement of feeding tubes. It is also utilized in embolization procedures to manage vascular abnormalities.
Evidence Summary
The available literature includes 13 studies, comprising randomized controlled trials, prospective and retrospective analyses, and case series, spanning from 2012 to 2023. These studies evaluate the device's efficacy and safety in various clinical applications.
Reported Outcomes
Published studies report that the percutaneous introducer kit is effective in reducing peristomal infection rates during percutaneous endoscopic gastrostomy. The device has been shown to facilitate safe and efficient vascular access, with some studies highlighting its utility in patients with upper digestive tract stenosis.
Safety Profile
Reported complications include peristomal infections, which have been reduced with the use of systemic prophylactic antibiotics. The device's design and technique have been associated with lower infection rates compared to traditional methods.
Evidence Limitations
While the studies provide valuable insights, there are limitations such as small sample sizes and the need for more randomized controlled trials to further validate findings. Future research could focus on long-term outcomes and comparisons with alternative devices.
Frequently Asked Questions
What are the clinical indications for percutaneous introducer kit?
The device is indicated for use in procedures requiring vascular access, such as percutaneous endoscopic gastrostomy and embolization.
What outcomes have been reported in clinical studies?
Studies have reported reduced infection rates and effective vascular access facilitation, particularly in gastrostomy procedures.
What complications have been reported?
Safety data indicate that complications such as peristomal infections can occur, but these are mitigated with prophylactic antibiotics.
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.