Medtech giant Covidien (NYSE:COV) this week touted FDA approval for its Apollo Onyx delivery micro catheter, the 1st FDA-approved device of its kind with a detachable tip.
The newly approved device is indicated for use during embolizations in patients with brain arteriovenous malformations, a neurovascular condition in which blood vessels in or on the brain pass blood directly from the arteries to the veins, rather than following normal channels. The Apollo Onyx is designed for use with Covidien’s Onyx liquid embolic system.
"Covidien is offering a new level of confidence for physicians by providing the only detachable tip micro catheter in the U.S.," Covidien neurovascular division president Brett Wall said in prepared remarks. "The Apollo Onyx micro catheter has the potential to improve patient outcomes by safeguarding the neurovasculature during catheter retrieval."
Covidien plans to showcase the device next month during the Society of NeuroInterventional Surgery’s 11th annual meeting in Colorado Spring, Colo., the company said.
The FDA approval marks another regulatory win for Covidien, which earlier this month announced CE Mark approval for its Nellcor respiration rate technology.
COV shares closed last night at $72.98, down 0.2% on the day.