Medtronic wins FDA OK for InterStim smart programmer
- Medtronic announced Monday it received FDA authorization for a smart programmer for its InterStim device to treat overactive bladder (OAB). The same day, Aortica Corporation announced the agency had approved a supplement enabling Medtronic's Navion stent graft system to be included in an aneurysm repair study.
- The newly-allowed programmer works with the implantable InterStim neuromodulation system for treating OAB, chronic fecal incontinence (FI) and non-obstructive urinary retention.
- Meanwhile, the Valiant Navion stent graft system was approved for use in an ongoing physician-sponsored study of fenestrated endovascular aneurysm repair at the University of Washington. The investigational device exemption study will incorporate Medtronic’s device with Aortica's software to treat abdominal aortic aneurysms (AAA).
The latest FDA clearances for Dublin-based Medtronic reflect the diversity of the device giant’s ever-evolving portfolio. Chief Executive Omar Ishrak last month said the company’s pipeline is the strongest in its 70-year history.
The InterStim neuromodulation device was approved 20 years ago for bladder and bowel control issues. The implanted neurostimulator electrically stimulates the sacral nerve to normalize communication between the bladder and brain.
According to Medtronic, more than 37 million adults in the United States suffer from OAB and nearly 20 million Americans have bowel incontinence.
The new programmer seeks to advance the InterStim treatment for these conditions using a touch-screen Samsung mobile device. The app-based platform provides physicians with a detailed view of the patient’s therapy experience to help personalize the treatment. The device also lets patients manage their therapy discreetly and adjust the treatment using seven preset programs.
The second FDA authorization allows Medtronic’s Valiant Navion stent graft system to be used with Aortica’s automated case planning software in an IDE study by Benjamin Starnes, chief of vascular surgery at the University of Washington. The device will be evaluated in the treatment of complex juxtarenal abdominal aortic aneurysms.
In a press release, Starnes said he hopes bringing the device into the study will address issues that have limited physician acceptance of fenestrated endovascular aneurysm repair. A fenestrated endograft is a procedure for AAA patients whose aneurysms are too close to the arteries that branch off to the kidneys for traditional endovascular aneurysm repair to work.
"By automating case planning to provide an accurate graft plan and coupling that with an appropriately designed endograft both the upfront planning and the procedure itself are dramatically simplified, and the endograft becomes 'personalized' to the individual patient’s anatomy. We believe this simplified, personalized approach will significantly increase the number of patients who are candidates for less invasive and personalized EVAR," Aortica CEO Tom Douthitt said.