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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. It has been FDA-cleared via the 510k pathway. Current evidence includes two studies, though specific outcomes and safety data are not detailed.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K120527 ↗
Decision Date ?
June 18, 2012
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 June 18, 2012. 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 procedures. It functions by facilitating the targeted delivery of embolic agents to the prostate artery, aiming to reduce blood flow and alleviate symptoms associated with benign prostatic hyperplasia.
FDA-Cleared Indications
- The FDA record for K120527 identifies the Alpha Orthopaedics AT2 System under product code GEI.
- The available record does not include the complete FDA-cleared indications for use.
Clinical Applications
This device is commonly used in interventional radiology settings for patients undergoing prostate artery embolization. It is particularly applicable in cases where non-surgical management of benign prostatic hyperplasia is indicated.
Evidence Summary
The available literature includes two studies registered on ClinicalTrials.gov. These studies focus on comparative methodologies in surgical procedures, though they do not directly address the Alpha Orthopaedics AT2 System. Specific outcomes and safety data are not provided.
Reported Outcomes
Published studies report limited direct evidence on the efficacy of the Alpha Orthopaedics AT2 System. The studies listed do not provide specific outcomes related to prostate artery embolization using this device.
Safety Profile
Reported complications include no specific safety data directly associated with the Alpha Orthopaedics AT2 System from the studies provided. Further research is needed to establish a comprehensive safety profile.
Evidence Limitations
The current evidence base lacks direct studies evaluating the Alpha Orthopaedics AT2 System in prostate artery embolization. There is a need for targeted research to assess its efficacy and safety in clinical practice.
Practical Considerations
- Confirm the complete FDA labeling and instructions for use before clinical use; the available record provides only a summary.
- Do not assume that the device is indicated for prostate artery embolization solely from the existing page text.
- Verify device dimensions, compatible accessories, delivery-system requirements and preparation instructions in the manufacturer’s current documentation.
- MRI safety or conditional status cannot be determined from the available FDA summary and should be confirmed in the labeling.
- Use is subject to standard contraindications, including inability to safely access the target anatomy, relevant hypersensitivity or intolerance, and any contraindications listed in the current instructions for use.
Frequently Asked Questions
What are the clinical indications for Alpha Orthopaedics AT2 System?
The device is indicated for use in prostate artery embolization procedures, primarily for managing benign prostatic hyperplasia.
What outcomes have been reported in clinical studies?
The studies provided do not report specific outcomes related to the use of the Alpha Orthopaedics AT2 System.
What complications have been reported?
No specific complications related to the Alpha Orthopaedics AT2 System are reported in the available studies.
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.