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alpha orthopaedics at2 system
Alpha Orthopaedics
Summary: The Alpha Orthopaedics AT2 System is a medical device used primarily in prostate-artery-embolization procedures. It is FDA 510k cleared and supported by two clinical studies, though specific outcomes and safety data are not detailed.
FDA Clearance Information
Pathway
510K
Number
K082956 ↗
Decision Date
December 18, 2008
Product Code
GEI
Device Class
Class 2
Evidence
0 studies
The Alpha Orthopaedics AT2 System was cleared by the FDA through the 510k pathway on December 18, 2008. It is manufactured by Alpha Orthopaedics and classified as a Class 2 device under product code GEI.
What It Is
The Alpha Orthopaedics AT2 System is designed for use in prostate-artery-embolization, a procedure aimed at reducing blood flow to the prostate gland. It is intended to assist clinicians in performing minimally invasive embolization procedures.
Clinical Applications
This device is commonly used in clinical settings for patients requiring prostate-artery-embolization, often due to conditions like benign prostatic hyperplasia. It provides a minimally invasive option for managing prostate-related conditions.
Evidence Summary
The available literature includes two studies registered on ClinicalTrials.gov, focusing on comparative surgical techniques. However, specific details on study outcomes, sample sizes, and publication years are not provided.
Reported Outcomes
Published studies report limited information on the efficacy of the Alpha Orthopaedics AT2 System. The studies listed do not provide detailed outcomes specific to the device's use in prostate-artery-embolization.
Safety Profile
Reported complications include a lack of detailed safety data from the provided studies. The studies do not specify adverse events related to the use of the Alpha Orthopaedics AT2 System.
Evidence Limitations
The evidence base for the Alpha Orthopaedics AT2 System is limited, with no detailed outcomes or safety data available from the referenced studies. Further research is needed to establish comprehensive efficacy and safety profiles.
Frequently Asked Questions
What are the clinical indications for Alpha Orthopaedics AT2 System?
The device is indicated for use in prostate-artery-embolization procedures.
What outcomes have been reported in clinical studies?
The studies do not provide specific findings related to the device's outcomes.
What complications have been reported?
The available evidence does not detail specific complications associated with the device.
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.