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FDA clears Covidien’s Apollo Onyx delivery micro catheter

Covidien has received the US Food and Drug Administration (FDA) approval for its Apollo Onyx delivery micro catheter designed to enhance Onyx Liquid Embolic System (LES) delivery.

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Considered to be the first detachable tip micro catheter in the US, the Apollo Onyx micro catheter will minimize the technical challenges of catheter retrieval during Onyx LES embolizations of brain arteriovenous malformations (bAVMs).

The new micro catheter will help physicians choose the best catheter position for each procedure, according to the company.

Mount Sinai Health Systems Hyman-Newman Institute for Neurology and Neurosurgery’s Endovascular Surgery Center director Dr. Alejandro Berenstein said the device will improve physicians’ options for treating patients with bAVMs.

"The Apollo Onyx micro catheter provides a very important added safety mechanism for catheter retrieval during Onyx LES embolizations of bAVMs, permitting a more complete treatment in a much safer manner," Berenstein added.

The catheter, which features a proprietary detachable tip for easier catheter retrieval, is expected to offer optimal navigability through complex distal anatomy.

Covidien Neurovascular president Brett Wall said, "The Apollo Onyx micro catheter has the potential to improve patient outcomes by safeguarding the neurovasculature during catheter retrieval."

A bAVM occurs when a tangle of blood vessels in the brain or on its surface bypasses normal brain tissue and directly diverts blood from the arteries to the veins.

bAVMs occur in approximately one in 200-500 people and are more common in males than in females, according to the American Heart Association.

The company will demonstrate the Apollo Onyx micro catheter at the Society of NeuroInterventional Surgery’s (SNIS) 11th annual meeting to be held 28July in Colorado Springs, Colorado, US.

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Image: Covidien’s Apollo Onyx delivery micro catheter. Photo: Business Wire.