đź“Š Evidence-Based Reference
novoste guiding catheter
Novoste
Summary: The Novoste guiding catheter is used in coronary brachytherapy procedures. It is primarily indicated for in-stent restenosis treatment. Key evidence highlights successful procedures using transradial approaches.
FDA Clearance Information
Pathway
510K
Number
K911527 ↗
Decision Date
April 24, 1991
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Novoste guiding catheter was cleared through the FDA 510(k) pathway on April 24, 1991. It is manufactured by Novoste and classified as a Class 2 device under product code DQY.
What It Is
The Novoste guiding catheter is a medical device used in coronary brachytherapy, particularly for treating in-stent restenosis. It facilitates the delivery of radiation therapy to coronary arteries, using a transradial approach.
Clinical Applications
This device is commonly used in interventional cardiology for patients with coronary artery disease experiencing in-stent restenosis. It is utilized in procedures requiring precise navigation through the arterial system.
Evidence Summary
The literature includes two studies focusing on the Novoste guiding catheter. These studies, published in 2001 and 2002, explore its use in coronary brachytherapy and the dosimetric effects of guide wires.
Reported Outcomes
Published studies report successful completion of coronary brachytherapy procedures using the Novoste guiding catheter. In one study, all lesions were successfully dilated without the need for additional stents. The device demonstrated effective navigation and delivery of therapy.
Safety Profile
Reported complications include potential dosimetric effects due to the presence of metallic guide wires during procedures. However, specific adverse events related to the catheter itself were not detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small sample size and lack of detailed safety outcomes. Further research is needed to explore long-term efficacy and safety, as well as comparisons with other devices.
Frequently Asked Questions
What are the clinical indications for Novoste guiding catheter?
The Novoste guiding catheter is indicated for use in coronary brachytherapy, particularly for treating in-stent restenosis.
What outcomes have been reported in clinical studies?
Studies report successful dilation of lesions and completion of procedures without additional stenting, demonstrating effective use in coronary brachytherapy.
What complications have been reported?
Reported complications include potential dosimetric effects from metallic guide wires, though specific adverse events related to the catheter were not detailed.
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.