The US Food and Drug Administration (FDA) has granted breakthrough device designation to Medtronic ’s minimally invasive Valiant TAAA Stent Graft System.
Valiant TAAA Stent Graft System is designed to repair a thoracoabdominal aortic aneurysm (TAAA). A TAAA causes swelling of the aorta, which extends from the chest into the abdomen.
Commonly, TAAA affects the branch arteries supplying blood to various internal organs. The condition accounts for approximately 15% of all thoracic aneurysms.
The standard of care for TAAA is open surgery, which is complex and known to cause high morbidity and mortality. 40% of patients are not considered eligible for treatment, added Medtronic.
Medtronic’s stent is intended to provide an off-the-shelf endovascular solution for treating the condition. Currently, the device is undergoing five investigational device exemption trials in the US.
Medtronic aortic business vice-president and general manager John Farquhar said: “In addition to a high mortality rate for open surgical repair, physicians do not have good options when it comes to treatment for failed endograft.
“The FDA’s breakthrough designation for Valiant TAAA and our collaboration with leading physicians is an example of our willingness to take a courageous approach and challenge the limitations of current treatment options. This is about going further, together to improve patient outcomes.”
The breakthrough status will provide Medtronic priority review and interactive communication with the FDA regarding device development and clinical trial protocols until commercialisation decisions.
In May, the company also secured breakthrough designation for the use of Valiant Navion LSA branch thoracic stent graft system to provide left subclavian artery (LSA) coverage during thoracic endovascular aortic repair (TEVAR) procedures.
Furthermore, Medtronic has submitted a pre-market approval (PMA) supplement application to the US regulator for approval of InterStim Micro, a rechargeable version of its 20-year-old sacral neuromodulation device.
InterStim Micro treats overactive bladder, urinary urge incontinence, unobstructed urinary retention and faecal incontinence.