Covidien plc (NYSE: COV) today announced U.S. Food and Drug Administration (FDA) approval of its Apollo™ Onyx™ delivery micro catheter - the first detachable tip micro catheter available in the U.S. The new micro catheter is designed to mitigate the technical challenges of catheter retrieval during Onyx™ LES embolizations of brain arteriovenous malformations (bAVMs).
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. Normally, arteries carry blood containing oxygen from the heart to the brain, and veins carry blood with less oxygen away from the brain and back to the heart. According to the American Heart Association, bAVMs occur in approximately one in 200-500 people and are more common in males than in females.
"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."
The Apollo Onyx micro catheter 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.
"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."
The Apollo Onyx micro catheter will be showcased at the Society of NeuroInterventional Surgery's (SNIS) 11th annual meeting to be held July 28 in Colorado Springs, Colo.
The FDA calls them ‘recalls,’ yet the targeted medical devices often remain in use