Omnilink Elite Vascular Balloon-Expandable Stent System

No FDA recalls found in the data synced 22 Oct 2026.

Trade Name

Omnilink Elite Peripheral Balloon-Expandable Stent System

Generic Name

STENT, ILIAC

PMA Number

P110043 ↗

FDA Product Code

NIO

Device Class

Class III

Advisory Committee

Cardiovascular

FDA Decision

APPR Approved

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• What specific blood vessel sizes and lesion lengths is the Omnilink Elite Vascular Balloon-Expandable Stent System designed to treat?

  The Omnilink Elite is intended for use in iliac arteries with reference vessel diameters between 5.0 mm and 11.0 mm, and for treating atherosclerotic lesions up to 50 mm in length. These specifications ensure compatibility with the anatomical constraints of the iliac arteries, where the device is deployed via a balloon catheter to restore blood flow.

• Is the Omnilink Elite Vascular Balloon-Expandable Stent System reusable, or is it meant for single-use only?

  The Omnilink Elite is explicitly supplied sterile and intended for single-use only. This aligns with standard sterile medical device protocols to prevent contamination and ensure patient safety, as reuse could compromise sterility and device integrity.

• How is the Omnilink Elite Vascular Balloon-Expandable Stent System deployed, and what guidance is required during the procedure?

  The Omnilink Elite is designed for percutaneous placement within the iliac arteries and requires radiographic visualization (e.g., fluoroscopy) to guide proper deployment. This ensures accurate positioning and expansion of the stent to treat atherosclerotic lesions effectively.

• What storage and handling precautions must be followed for the Omnilink Elite Vascular Balloon-Expandable Stent System?

  Since the Omnilink Elite is sterile and single-use, storage and handling must adhere to sterile medical device protocols to maintain integrity. This includes keeping the device in its original packaging until use and following manufacturer guidelines to prevent contamination or damage before deployment.

• What regulatory pathway was followed for the approval of the Omnilink Elite Vascular Balloon-Expandable Stent System?

  The Omnilink Elite was approved through the FDA’s Premarket Approval (PMA) process, which is required for Class III devices. The approval (PMA #P110043) confirms its safety and effectiveness for treating atherosclerotic iliac artery lesions within the specified vessel sizes and lesion lengths.