Embolic beads

Optisphere

by Teleflex Incorporated

A bioabsorbable preformed device made from animal-derived (e.g., porcine) materials intended to be implanted in a non-neurovascular blood vessel, permanently or long-term, to occlude blood flow typically for treatment of an aneurysm, tumour (e.g., nephroma, hepatoma, uterine fibroids), and/or arteriovenous malformation (AVM). It is typically in the form of a gelatin foam pledget and may be supplied with dedicated instruments for implantation. This device is not intended to be used in intracranial arteries or for other neurovascular applications.

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Optisphere models and sizes

From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.

Model / catalog no.SizeMRIStatus
IPN913223Particle Size 100 µm; Particle Size 300 µm Not statedAvailable
IPN913224Particle Size 100 µm; Particle Size 300 µm Not statedAvailable
IPN913225Particle Size 300 µm; Particle Size 500 µm Not statedAvailable
IPN913226Particle Size 300 µm; Particle Size 500 µm Not statedAvailable
IPN913227Particle Size 500 µm; Particle Size 700 µm Not statedAvailable
IPN913228Particle Size 500 µm; Particle Size 700 µm Not statedAvailable
IPN913229Particle Size 600 µm; Particle Size 800 µm Not statedAvailable
IPN913230Particle Size 600 µm; Particle Size 800 µm Not statedAvailable
IPN913231Particle Size 700 µm; Particle Size 1000 µm Not statedAvailable
IPN913232Particle Size 700 µm; Particle Size 1000 µm Not statedAvailable

Procedures that use embolic beads

Frequently asked questions

What is Optisphere used for?

A bioabsorbable preformed device made from animal-derived (e.g., porcine) materials intended to be implanted in a non-neurovascular blood vessel, permanently or long-term, to occlude blood flow typically for treatment of an aneurysm, tumour (e.g., nephroma, hepatoma, uterine fibroids), and/or arteriovenous malformation (AVM). It is typically in the form of a gelatin foam pledget and may be supplied with dedicated instruments for implantation. This device is not intended to be used in intracranial arteries or for other neurovascular applications.

Who makes Optisphere?

Optisphere is made by Teleflex Incorporated. It is listed under embolic microspheres and particles (beads) in our device library.

What sizes does Optisphere come in?

Sizes listed for Optisphere: Particle Size: 100–1,000 µm. Confirm availability with the manufacturer's instructions for use.

Is Optisphere MRI safe?

The FDA device database entry for Optisphere does not state its MRI safety status. Check the labeling before MRI.

Is Optisphere FDA cleared?

Optisphere is registered in the FDA's Global Unique Device Identification Database (GUDID).

How do I contact a Teleflex Incorporated sales representative?

Teleflex Incorporated has not listed representatives on LA Vascular yet. Visit the Teleflex Incorporated company page for contact details.

Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.

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