FDA Approval for Covidien’s Neurovascular Micro Catheter

Covidien plc has gained U.S. FDA approval for its Apollo™ Onyx™ delivery micro catheter – the first detachable tip micro catheter available in the U.S.

Background

A brain arteriovenous malformations (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. The surgical trick to deal with these conditions is to inject an embolizing agent into the target vessels, so cutting off the short-cut.  

Covidien’s new Apollo Onyx micro catheter is designed to mitigate the technical challenges of catheter retrieval during Onyx™ LES embolizations of bAVMs. Furthermore the company says it enables physicians to choose the best catheter position for each procedure. It provides optimal navigability through complex distal anatomy as well as a proprietary detachable tip designed for easier catheter retrieval in challenging environments.

Physician comments 

“This new game-changing device will improve physicians’ options for treating patients with bAVMs,” said Dr. Alejandro Berenstein, director, Center for Endovascular Surgery at the Hyman-Newman Institute for Neurology and Neurosurgery at Mount Sinai Health Systems in New York City. “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.”

Company comments 

“Covidien is offering a new level of confidence for physicians by providing the only detachable tip micro catheter in the U.S.,” said Brett Wall, president, Neurovascular, Covidien. “The Apollo Onyx micro catheter has the potential to improve patient outcomes by safeguarding the neurovasculature during catheter retrieval.”

Source: Covidien plc., Business Wire

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