Medtronic Gets FDA's Breakthrough Device Nod For Valiant TAAA
Zacks Investment Research | Oct 09, 2019 07:56AM ET
Medtronic plc (NYSE:MDT) recently obtained the Breakthrough Device designation from the FDA for its Valiant TAAA Stent Graft System, designed for the minimally invasive repair of thoracoabdominal aortic aneurysm (TAAA).
This latest approval is expected to expand Medtronic’s Aortic, Peripheral & Venous line within the broader Cardiac and Vascular group.
More About Valiant TAAA
The Valiant TAAA is currently under evaluation in the United States in five physician-sponsored investigational device exemption (PS-IDE) trials, which are being conducted for the treatment of TAAA. The Valiant TAAA aims to offer an endovascular solution with a size matrix that will enable patient applicability for one of vascular surgery’s most complex pathologies.
This designation from the FDA will enable surgeons to deliver swifter treatment to patients in need. Henceforth, the agency will offer Medtronic facilities like Priority Review and interactive communication pertaining to device development, clinical trial protocols and decisions of commercialization.
This designation for Valiant TAAA and Medtronic’s collaboration with leading physicians are in sync with its commitment to overcome the limitations of currently prevailing treatment options.
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