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FDA Approves First Detachable-Tip Microcatheter
June 11, 2014
2 Min Read
Covidien plc (Dublin, Ireland) has announced that FDA has approved its Apollo Onyx delivery microcatheter, the first detachable-tip microcatheter available in the United States. The new microcatheter is designed to mitigate the technical challenges of catheter retrieval during Onyx Liquid Embolic System (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 diverts blood directly from the arteries to the veins. The American Heart Association says that bAVMs occur in approximately one in 200-500 people, and are more common in males than in females.
Covidien's Apollo Onyx Delivery Microcatheter (Courtesy Covidien plc)
"This new game-changing device will improve physicians' options for treating patients with bAVMs," said Alejandro Berenstein, MD, 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 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."
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 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 microcatheter in the United States," said Brett Wall, president, Neurovascular, Covidien. "The Apollo Onyx microcatheter has the potential to improve patient outcomes by safeguarding the neurovasculature during catheter retrieval."
Covidien recently posted a 3.2 percent rise in its second quarter, fiscal 2014, adjusted earnings per share, up to 96 cents. This is up from 93 cents a year ago. According to Zacks.com, the marginal rise in earnings was attributable to adverse impacts from foreign exchange movements and the medical device excise tax. Covidien's net earnings fell 2.2 percent to $435 million from $445 million due to a decrease in weighted average shares outstanding.
The company's total revenues in the quarter grew 2.7 percent to $2.598 billion, which missed Zacks' Consensus Estimate of $2.610 billion. On a geographic basis, revenues in the U.S. market increased 1.6 percent to $1.277 billion while revenues from non-U.S. developed markets rose 1.8 percent to $938 million. Meanwhile, revenues from emerging markets went up 8.8 percent to $383 million.
Refresh your medical device industry knowledge at MEDevice San Diego, September 10-11, 2014.
Zacks says that Covidien has reiterated its revenues outlook for fiscal 2014. Previously, the company said that it expects revenues to grow 2-5 percent year over year at a constant currency rate for fiscal 2014.
Stephen Levy is a contributor to Qmed and MPMN.
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