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modified ptca guiding catheters
Cordis
Summary: Modified PTCA guiding catheters by Cordis are used in percutaneous coronary interventions. They are FDA 510k cleared and linked to 10 studies. Key evidence highlights their role in managing procedural complications.
FDA Clearance Information
Pathway
510K
Number
K862975 ↗
Decision Date
September 23, 1986
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The modified PTCA guiding catheters by Cordis were cleared through the FDA 510k pathway on September 23, 1986. They are classified as Class 2 devices under product code DQY.
What It Is
Modified PTCA guiding catheters are specialized devices used in percutaneous coronary interventions to guide other instruments to the site of a coronary lesion. They are designed to facilitate the delivery of therapeutic devices such as balloons and stents.
Clinical Applications
These catheters are commonly used in scenarios requiring precise navigation and support during coronary angioplasty and stenting procedures. They are particularly useful in complex cases involving calcified lesions or vessel tortuosity.
Evidence Summary
The literature includes 10 studies, comprising case reports, RCTs, and other study types, published between 2020 and 2025. These studies explore various techniques and outcomes associated with the use of modified PTCA guiding catheters.
Reported Outcomes
Published studies report that modified PTCA guiding catheters are effective in managing procedural complications such as coronary perforation and balloon deflation failure. They have been shown to facilitate successful recanalization and improve procedural outcomes in complex coronary interventions.
Safety Profile
Reported complications include coronary perforation and restenosis, which are procedural risks associated with percutaneous coronary interventions. However, the use of modified guiding catheters has been shown to mitigate some of these risks by improving procedural precision.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to establish long-term outcomes and to compare the efficacy of different catheter modifications.
Frequently Asked Questions
What are the clinical indications for modified PTCA guiding catheters?
The clinical indications include use in percutaneous coronary interventions, particularly in cases involving complex lesions or procedural complications.
What outcomes have been reported in clinical studies?
Studies report improved procedural outcomes, including successful recanalization and management of complications like coronary perforation.
What complications have been reported?
Safety data indicate risks such as coronary perforation and restenosis, though these are mitigated by the catheter's design and application.
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.