- A stent graft system being developed by Medtronic for minimally invasive repair of thoracoabdominal aortic aneurysm (TAAA) received breakthrough device designation from FDA, the company announced Tuesday.
- The condition causes a bulging of the aorta and accounts for approximately 15% of all thoracic aneurysms, the company said. Medtronic said its Valiant TAAA device, developed in collaboration with a Sanford Health vascular surgeon, is currently being assessed in five physician-sponsored IDE trials.
- Also this week, Medtronic began a worldwide pivotal trial of an extravascular ICD system and submitted PMA supplements related to its InterStim sacral neuromodulation system.
Thoracoabdominal aortic aneurysm is typically treated via complex open surgery, for which 40% of patients are not candidates, Medtronic 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 endografts," John Farquhar, vice president and general manager of the aortic business in Medtronic's Cardiac and Vascular Group, said in the announcement Tuesday.
Also this week, Medtronic announced it had begun a worldwide pivotal study of its extravascular implantable cardioverter defibrillator system.
Separately, Medtronic said it submitted a PMA supplement with FDA for InterStim Micro neurostimulator, a rechargeable, implantable sacral neuromodulation device for use in patients with urinary or fecal incontinence or overactive bladder. Niche medtech Axonics introduced a challenge to InterStim's market dominance in September when it won premarket approval from FDA.
Medtronic also said it received breakthrough designation in May for a branch thoracic stent graft system intended for use during thoracic endovascular aortic repair. In February, the medtech giant's in-development personalized closed loop insulin pump system was selected for the program.
FDA's Breakthrough Devices Program is meant to increase and fast track communication between regulators and manufacturers of technologies designed to diagnose or treat life-threatening or irreversibly debilitating diseases or conditions. While it's up to manufacturers to decide to publicly disclose the designation, Center for Devices and Radiological Health Director Jeff Shuren recently said FDA is open to considering publicizing program participants on its own.
Building on popularity of the breakthrough program, which has awarded more than 200 designations in its few years of existence, FDA unveiled more information last month on its Safer Technologies Program, designed to mirror the interactive, expedited elements of the Breakthrough Devices Program, but intended for technologies anticipated to "significantly improve" upon existing treatments for non-life-threatening diseases.