Covidien gets FDA approval for Apollo Onyx delivery micro catheter

10 June 2014 (Last Updated June 10th, 2014 18:30)

The US Food and Drug Administration (FDA) has approved Ireland-based Covidien's Apollo Onyx delivery micro catheter.

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The US Food and Drug Administration (FDA) has approved Ireland-based Covidien's Apollo Onyx delivery micro catheter.

Claimed to be the first detachable tip micro catheter in the US, it will minimise the technical challenges of catheter retrieval during Onyx liquid embolic system (LES) embolisations of brain arteriovenous malformations (bAVMs).

The new micro catheter allows physicians to select the best device position for each procedure and is also expected to offer optimal navigability through complex distal anatomy.

The device features proprietary detachable tip for easier catheter retrieval in challenging environments.

"The Apollo Onyx micro catheter has the potential to improve patient outcomes by safeguarding the neurovasculature during catheter retrieval."

Mount Sinai Health Systems Hyman-Newman Institute for Neurology and Neurosurgery Endovascular Surgery Center director Alejandro Berenstein said: "The Apollo Onyx micro catheter provides a very important added safety mechanism for catheter retrieval during Onyx LES embolisations of bAVMs, permitting a more complete treatment in a much safer manner."

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

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."

The company is focused on developing, manufacturing and selling a range of medical device and supply products.


Image: Covidien's Apollo Onyx delivery micro catheter, the first detachable tip micro catheter available in the US. Photo: courtesy of Business Wire.