KORTHOS / ECOSYSTEM / PRODUCT

Iris Endovascular Robotic System

About

About Iris Endovascular Robotic System

Iris Endovascular Robotic System is a bedside device-manipulation platform with a cassette controller carried on a positioning arm. A system cart supports installation and positioning beside the patient, while the physician operates from a separate console. The design is intended to accommodate guidewires, catheters and treatment devices in local or telerobotic procedures.

XCath also develops ElectroSteer, a guidewire with an electrically actuated tip that bends in two directions and is visible under fluoroscopy. It is designed for integration with Iris or operation through a separate handheld controller. Iris remains under development and is not available for sale or use worldwide.

Timeline

  • XCath’s Iris surgical robot enters FDA TAP programme

    2026-10-08 - Regulatory - Enrollment follows Iris’s September 2, 2026 Breakthrough Device designation. A dedicated FDA advisor and review-team engagement will cover development decisions, with facilitated input from payers, providers and other stakeholders. Iris remains under development and is not cleared for commercial distribution in any country.

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  • XCath Iris completes first in-human telerobotic stroke procedure

    2026-04-23 - Deployment - Dr. Vitor Mendes Pereira operated from a control room in Santiago, Panama, about 200 kilometres from the patient at Panama Clinic in Panama City. The procedure was overseen locally by principal investigator Dr. Anastasio Ameijeiras Sibauste and used remote robotic mechanical thrombectomy for an ischemic stroke. Crescent Enterprises reported submillimetre precision, no perceptible latency and successful treatment in the landmark remote intervention.

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  • XCath EVR robotic system performs first-in-human brain aneurysm procedures

    2025-11-12 - Deployment - XCath announced first-in-human use of its EVR robotic system to treat three patients with complex brain aneurysms at The Panama Clinic. The procedures marked only the second time a surgical robot had been used in an intracranial neurovascular intervention. The milestone established a major clinical proof point ahead of commercialization and later Series C financing.

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Context

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