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nhancer rx
Imds Operations
Summary: Nhancer Rx is a microcatheter used in interventional cardiology, particularly for chronic total occlusion (CTO) procedures. It is used by interventional cardiologists to improve guidewire support during percutaneous coronary interventions (PCI).
FDA Clearance Information
Pathway
510K
Number
K200324 ↗
Decision Date
August 6, 2020
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
Nhancer Rx was cleared via the FDA 510(k) pathway on August 6, 2020. Manufactured by Imds Operations, it is classified as a Class 2 device under product code DQY.
What It Is
Nhancer Rx is a microcatheter designed to assist in the delivery of guidewires and other interventional tools during percutaneous coronary interventions (PCI), especially in challenging cases like chronic total occlusions (CTO). It provides enhanced deliverability and resistance to deformation, which are critical for navigating complex vascular pathways.
Clinical Applications
Nhancer Rx is commonly used in interventional cardiology settings, particularly in procedures involving chronic total occlusions (CTO) where enhanced guidewire support is necessary. It is utilized in catheterization labs by interventional cardiologists to facilitate the crossing of occluded vessels and improve procedural success rates in patients with coronary artery disease.
Indications for Use
The FDA indications for Nhancer Rx involve its use in facilitating guidewire delivery during percutaneous coronary interventions (PCI), particularly in cases of chronic total occlusion (CTO). It is intended for patients with coronary artery blockages that are difficult to treat with standard techniques.
Practical Considerations
Nhancer Rx is typically compatible with standard PCI equipment and is available in various sizes to accommodate different vessel anatomies. Clinicians should be aware of its enhanced deliverability and deformation resistance, which can aid in navigating tortuous or calcified vessels.
Related Literature
The linked study reviews recent advances in microcatheter technology, including the Nhancer Rx, for treating chronic total occlusions (CTO) in percutaneous coronary interventions (PCI). It highlights the improved deliverability and resistance to deformation of these devices. However, the study notes the need for more clinical experience and comparative effectiveness studies to fully understand their impact in contemporary CTO PCI.
Frequently Asked Questions
What is Nhancer Rx used for?
Nhancer Rx is used to facilitate guidewire delivery during percutaneous coronary interventions, particularly in chronic total occlusions.
What specialties typically use this device?
Interventional cardiologists use this device in catheterization labs for coronary interventions.
What are the FDA-cleared indications?
Nhancer Rx is indicated for use in facilitating guidewire delivery during PCI, especially in chronic total occlusion cases.
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.