Medtronic Gets FDA Breakthrough Tag for Valiant TAAA Stent Graft System

Medtronic PLC (MDT) said Tuesday it received Breakthrough Device designation from the U.S. Food and Drug Administration for its Valiant TAAA Stent Graft System for minimally invasive repair of thoracoabdominal aortic aneurysm.
A TAAA is a complex condition causing a bulging of the aorta, which extends from the chest down into to the abdomen.
The FDA Breakthrough Device Program is intended to help patients receive more timely access to breakthrough technologies, the company said. Under the program, the FDA will provide Medtronic with priority review and interactive communication regarding device development and clinical trial protocols, through to commercialization decisions.

https://www.marketscreener.com/MEDTRONIC-PLC-20661655/news/Medtronic-Gets-FDA-Breakthrough-Device-Designation-for-Valiant-TAAA-Stent-Graft-System-29350567/