The Fridley, Minn.-based medical device company said the 7-patient trial is being run under the auspices of an IDE from the FDA, to investigate the Valiant Mona LSA in the treatment of aortic aneurysms involving the left subclavian artery, which feeds part of the brain and the left arm.
It’s a modification of Medtronic’s Valiant stent graft to incorporate a branch cuff for the LSA branch graft, according to a press release.
"This study will advance the development of future devices for the endovascular repair of aortic aneurysms that involve branch vessels," Tony Semedo, president & general manager of Medtronic’s endovascular therapies business, said in prepared remarks. "It represents a gateway to stent grafts that could be used to treat aneurysmal disease across the aorta’s thoracic arch and ascending segment."
Earlier this month Medtronic won CE Mark approval in the European Union for its Sentrant introducer sheath, designed to be used with the Valiant Captivia and Endurant II stent grafts.