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asahi veloute asahi veloute c3 asahi tellus asahi tellus c3
Asahi Intecc
Summary: The Asahi Veloute and Tellus are venous stents used to treat venous obstructions. They are primarily utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K241158 ↗
Decision Date
June 25, 2024
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Asahi Veloute and Tellus stents were cleared through the FDA 510(k) pathway on June 25, 2024, by Asahi Intecc. They are classified as Class 2 medical devices.
What It Is
The Asahi Veloute and Tellus are venous stents designed to restore patency in obstructed veins. These stents are typically made from a flexible metal mesh that can expand to fit the vessel's lumen, providing structural support and maintaining blood flow. They are used in minimally invasive procedures and are delivered to the target site via a catheter.
Clinical Applications
These stents are commonly used in procedures to treat conditions such as chronic venous insufficiency or post-thrombotic syndrome. Interventional radiologists and vascular surgeons often deploy these devices in hospital settings or specialized vascular centers. They are suitable for adult patients experiencing venous blockages that impair circulation.
Indications for Use
The FDA-cleared indications for the Asahi Veloute and Tellus stents include the treatment of venous obstructions. These devices are intended for patients with conditions that lead to narrowed or blocked veins, requiring mechanical support to restore normal blood flow.
Practical Considerations
The stents come in various sizes to accommodate different vessel diameters and lengths. Compatibility with standard delivery systems is expected, and clinicians should be trained in endovascular techniques for optimal deployment. Proper sizing and placement are crucial to ensure effective treatment and minimize complications.
Frequently Asked Questions
What is the Asahi Veloute used for?
The Asahi Veloute is used to treat venous obstructions by providing structural support to maintain blood flow in affected veins.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device in procedures to treat venous diseases.
What are the FDA-cleared indications?
The FDA-cleared indications include treating venous obstructions in patients with conditions like chronic venous insufficiency.
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.