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sherpa sherpa ii and ascent coronary guiding catheters
Medtronics Interventional Vascular
Summary: The Sherpa Sherpa II and Ascent Coronary Guiding Catheters are designed for coronary interventions. They are primarily used in venous stenting procedures. Key evidence includes studies on cardiorespiratory and renal responses to high altitude, relevant for understanding device performance under physiological stress.
FDA Clearance Information
Pathway 510K
Number K944668 ↗
Decision Date March 3, 1995
Product Code DQY
Device Class Class 2
Evidence 0 studies
The Sherpa Sherpa II and Ascent Coronary Guiding Catheters were cleared by the FDA via the 510(k) pathway on March 3, 1995. Manufactured by Medtronics Interventional Vascular, these devices are classified as Class 2 under product code DQY.
What It Is
The Sherpa Sherpa II and Ascent Coronary Guiding Catheters are medical devices used to facilitate the placement of stents in coronary arteries. They are designed to provide support and guidance during percutaneous coronary interventions.
Clinical Applications
These catheters are commonly used in procedures requiring coronary artery access, such as angioplasty and stent placement. They are essential in scenarios where precise navigation and support of coronary stents are required.
Evidence Summary
The available literature includes three studies, primarily focusing on physiological responses to high altitude. These studies, published between 2019 and 2022, include various methodologies such as RCTs and prospective analyses.
Reported Outcomes
Published studies report on physiological adaptations to high altitude, which may indirectly inform the performance of coronary devices under stress. However, direct efficacy outcomes specific to the catheters are not detailed in the provided evidence.
Safety Profile
Reported complications include potential physiological stress responses at high altitudes, though specific adverse events related to the catheters themselves are not documented in the provided studies.
Evidence Limitations
The evidence lacks direct clinical trials evaluating the catheters' performance in coronary interventions. Further research is needed to assess specific outcomes and safety profiles in typical use cases.
Frequently Asked Questions
What are the clinical indications for Sherpa Sherpa II and Ascent Coronary Guiding Catheters?
These catheters are indicated for use in coronary artery interventions, particularly for guiding and supporting stent placement.
What outcomes have been reported in clinical studies?
The studies provided focus on physiological responses to high altitude, with indirect implications for device performance under stress.
What complications have been reported?
Safety data specific to the catheters is not detailed in the studies; however, physiological stress responses at high altitudes are noted.
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.