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June 10, 2014

FDA Approves Covidien's Apollo Onyx Delivery Microcatheter for Neurovascular Procedures

June 11, 2014—Covidien announced US Food and Drug Administration (FDA) approval of its Apollo Onyx delivery microcatheter. The detachable-tip microcatheter is designed to mitigate the technical challenges of catheter retrieval during Onyx liquid embolic system (LES) embolizations of brain arteriovenous malformations (bAVMs).

According to the company, the Apollo Onyx microcatheter enables physicians to choose the best catheter position for each procedure. It provides optimal navigability through complex distal anatomy, as well as a detachable tip designed for easier catheter retrieval in challenging environments. Covidien will showcase the Apollo Onyx microcatheter at the Society of NeuroInterventional Surgery’s 11th annual meeting, to be held July 28 in Colorado Springs, Colorado.

In Covidien’s press release, Alejandro Berenstein, MD, Director of the Center for Endovascular Surgery at the Hyman-Newman Institute for Neurology and Neurosurgery at Mount Sinai Health Systems in New York, New York, commented, “This new game-changing device will improve physicians’ options for treating patients with bAVMs. The Apollo Onyx microcatheter 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.”

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June 11, 2014

Medtronic Submits Final PMA Module to FDA for In.Pact Admiral DCB to Treat Femoropopliteal Disease

June 11, 2014

Medtronic Submits Final PMA Module to FDA for In.Pact Admiral DCB to Treat Femoropopliteal Disease


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