The Valiant graft with the Captivia delivery system is now indicated to treat all DTA lesions, with the exception of dissections, and is only the 2nd endovascular stent grafting device approved to treat isolated lesions of the thoracic aorta, the FDA noted.
Medtronic originally won PMA approval for Valiant in April 2011, but the device was indicated only for treatment of "fusiform aneurysms and saccular aneurysms/penetrating ulcers of the descending thoracic aorta in patients having appropriate anatomy," according to the regulatory notice.
The Valiant device is a polyester tube with a self-expanding metallic outer stent, which is compressed into a delivery catheter and threaded into the patient’s thoracic aorta to treat vessel damage that can be caused by disease or trauma.
Medtronic has other Valiant graft system still in the midst of regulatory approval. Over the summer the FDA accepted the Valiant Mona LSA system for review under a new feasibility pilot program with the federal watchdog agency that allows for "early clinical evaluation to provide proof of principle and initial clinical safety data," according to the FDA.
MDT closed at a 1.1% decline last night, trading at $41.06 at the end of the day.
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