FDA News

Stent graft system for thoracoabdominal aortic aneurysms receives FDA breakthrough designation

Medtronic announced that a stent graft system for the minimally invasive repair of thoracoabdominal aortic aneurysms has received breakthrough device designation from the FDA.

Through this designation, the stent graft system (Valiant) will receive priority review and communication with the FDA about clinical trial protocol and device development, according to a press release from the company.

“Breakthrough designation from the FDA means that we will be able to deliver this much needed treatment to patients sooner than expected,” Murray Shames, MD, professor and chief of the division of vascular surgery at the University of South Florida Morsani College of Medicine and an investigator for the stent graft system, said in the release. “Physicians and industry must continue to innovate and provide hope for those with challenging disease states.”

The stent graft system is currently being evaluated in five physician-sponsored trials for the treatment of patients with thoracoabdominal aortic aneurysm, according to the release.

“In addition to a high mortality rate for open surgical repair, physicians do not have good options when it comes to treatment for failed endografts,” John Farquhar, vice president and general manager of the aortic business of the cardiac and vascular group at Medtronic, said in the release. “This is about going further together to improve patient outcomes.”

Disclosures: Shames reports he conducts research for Medtronic. Farquhar is an employee of Medtronic.

Medtronic announced that a stent graft system for the minimally invasive repair of thoracoabdominal aortic aneurysms has received breakthrough device designation from the FDA.

Through this designation, the stent graft system (Valiant) will receive priority review and communication with the FDA about clinical trial protocol and device development, according to a press release from the company.

“Breakthrough designation from the FDA means that we will be able to deliver this much needed treatment to patients sooner than expected,” Murray Shames, MD, professor and chief of the division of vascular surgery at the University of South Florida Morsani College of Medicine and an investigator for the stent graft system, said in the release. “Physicians and industry must continue to innovate and provide hope for those with challenging disease states.”

The stent graft system is currently being evaluated in five physician-sponsored trials for the treatment of patients with thoracoabdominal aortic aneurysm, according to the release.

“In addition to a high mortality rate for open surgical repair, physicians do not have good options when it comes to treatment for failed endografts,” John Farquhar, vice president and general manager of the aortic business of the cardiac and vascular group at Medtronic, said in the release. “This is about going further together to improve patient outcomes.”

Disclosures: Shames reports he conducts research for Medtronic. Farquhar is an employee of Medtronic.