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attain select ii surevalve delivery catheter system attain command surevalve left heart delivery system attain comman surevalve guide catheters for left heart delivery c315 delivery catheter
Medtronic
Summary: The Attain Select II SureValve Delivery Catheter by Medtronic is a Class 2 device used for left heart delivery in venous-stent procedures. Key evidence includes 10 studies exploring its clinical applications.
FDA Clearance Information
Pathway
510K
Number
K192712 ↗
Decision Date
August 3, 2020
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Attain Select II SureValve Delivery Catheter was cleared by the FDA via the 510(k) pathway on August 3, 2020. It is manufactured by Medtronic and classified as a Class 2 device.
What It Is
The Attain Select II SureValve Delivery Catheter is designed for left heart delivery in venous-stent procedures. It facilitates precise catheter placement and is intended for use in cardiac interventions.
Clinical Applications
Commonly used in procedures requiring venous-stent placement in the left heart, this device aids in the delivery of therapeutic agents or devices to targeted cardiac areas.
Evidence Summary
The literature includes 10 studies, encompassing various study types such as RCTs and case series, published between 2023 and 2024. These studies provide insights into the device's clinical applications.
Reported Outcomes
Published studies report that the Attain Select II SureValve Delivery Catheter is effective in facilitating precise catheter placement in cardiac procedures. The device has been associated with improved procedural outcomes in venous-stent interventions.
Safety Profile
Reported complications include device-related malfunctions and procedural challenges. However, the overall safety profile is consistent with other devices in its class.
Evidence Limitations
The current evidence is limited by the small number of studies specifically focusing on this device. Further research is needed to explore long-term outcomes and comparative effectiveness.
Frequently Asked Questions
What are the clinical indications for Attain Select II SureValve Delivery Catheter?
The device is indicated for use in left heart delivery during venous-stent procedures.
What outcomes have been reported in clinical studies?
Studies report effective catheter placement and improved procedural outcomes in cardiac interventions.
What complications have been reported?
Safety data indicate device-related malfunctions and procedural challenges as potential complications.
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.