Houston-based XCath says the designation provides increased opportunities to interact with FDA experts and receive support during the regulatory development and review process for Iris. The designation comes about six months after the company achieved the first telerobotic stroke case using the robot, in which a neurosurgon in Panama treating a patient 120 miles away.
XCath officials think Iris could break down the geographic barriers to specialized stroke care by enabling physicians to remotely provide mechanical thrombectomy procedures.
“FDA Breakthrough Device Designation is an important milestone for our mission,” XCath Robotics CEO Eduardo Fonseca said in a Sept. 10 news release. “We look forward to continued collaboration with the FDA as we advance the development and evaluation of the Iris system. The real-world learnings from our investigational cases are helping us shape the system to expand access to life-saving stroke care for the millions of patients we ultimately hope to serve.”
