đź“Š Evidence-Based Reference
alliance left heart delivery system introducer model 407509
Daig
Summary: The Alliance Left Heart Delivery System Introducer by Daig is a Class 2 medical device cleared by the FDA for use in embolization-coils procedures. Key evidence includes studies on heart failure and myocardial repair.
FDA Clearance Information
Pathway
510K
Number
K000004 ↗
Decision Date
November 29, 2000
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Alliance Left Heart Delivery System Introducer, manufactured by Daig, was cleared through the FDA 510k pathway on November 29, 2000. It is classified as a Class 2 device under product code DYB.
What It Is
The Alliance Left Heart Delivery System Introducer is a medical device designed to facilitate the delivery of embolization coils into the left heart. It is used in interventional cardiology to assist in procedures requiring precise placement of therapeutic devices.
Clinical Applications
This device is commonly used in clinical scenarios involving embolization procedures within the left heart. It provides a reliable means for clinicians to introduce coils and other therapeutic devices during interventional cardiology procedures.
Evidence Summary
The available literature includes 11 studies, primarily focusing on heart failure and myocardial repair. These studies range from 2011 to 2024 and include various study types such as RCTs and retrospective analyses.
Reported Outcomes
Published studies report improvements in heart failure management and myocardial repair using related therapeutic strategies. The evidence highlights the potential benefits of SGLT2 inhibitors and pro-angiogenic macrophage phenotypes in enhancing cardiac function.
Safety Profile
Reported complications include potential adverse events related to heart failure management and myocardial repair procedures. The studies emphasize the importance of monitoring for readmissions and kidney function in patients undergoing these treatments.
Evidence Limitations
The evidence is limited by the variability in study designs and the focus on specific therapeutic strategies rather than the device itself. Further research is needed to directly evaluate the device's efficacy and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for the Alliance Left Heart Delivery System Introducer?
The device is indicated for use in embolization-coils procedures within the left heart, particularly in interventional cardiology.
What outcomes have been reported in clinical studies?
Studies have reported improvements in heart failure management and myocardial repair, highlighting the benefits of related therapeutic strategies.
What complications have been reported?
Reported complications include potential adverse events related to heart failure management, such as readmissions and kidney function issues.
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.