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Sapphire Elevare Sapphire
Omm Imports, Inc. D/B/A Zero Gravity
Summary: The Sapphire Elevare Sapphire is a medical device used in the management of aortic conditions, specifically in procedures involving aortic stent-grafts. It is typically utilized by vascular surgeons and interventional radiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K172555 ↗
Decision Date ?
May 1, 2018
Product Code ?
OLP
Device Class ?
Class 2
Evidence ?
0 studies
The Sapphire Elevare Sapphire was cleared through the FDA's 510(k) pathway on May 1, 2018. It is manufactured by Omm Imports, Inc. and classified as a Class 2 device under product code OLP.
What It Is
The Sapphire Elevare Sapphire is a specialized medical device designed for use in aortic stent-graft procedures. It functions by providing support and structure to the aorta, helping to manage conditions such as aneurysms or dissections. The device is typically used in minimally invasive procedures, offering an alternative to open surgical repair.
FDA-Cleared Indications
- Use in procedures involving aortic stent-grafts.
- Management of aortic conditions requiring endovascular stent-graft placement, as specified by the device labeling.
Clinical Applications
- Use during endovascular repair of selected aortic aneurysms when an aortic stent-graft is indicated.
- Use during endovascular treatment of selected aortic dissections requiring stent-graft placement.
- Use in hospital-based vascular and interventional radiology procedures involving deployment or management of an aortic stent-graft.
Practical Considerations
- Confirm that the available device size and configuration match the patient's aortic anatomy and the planned stent-graft system.
- Verify compatibility with the intended endovascular equipment before the procedure.
- Use requires clinicians trained in endovascular aortic procedures and image-guided device handling.
- Review the manufacturer's instructions for contraindications, deployment limitations, storage, and handling requirements.
- MRI safety and conditional-use information should be confirmed in the current labeling; it should not be assumed from the device name alone.
Frequently Asked Questions
What is Sapphire Elevare Sapphire used for?
It is used for managing aortic conditions, specifically in procedures involving aortic stent-grafts.
What specialties typically use this device?
Vascular surgeons and interventional radiologists typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in aortic conditions requiring stent-graft placement, such as aneurysms or dissections.
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.