Stereotaxis Announces First-in-Human Coronary Intervention Study Results
- 100% clinical success and no device-related adverse events in 20 First-in-Human Percutaneous Coronary Intervention procedures with next-generation robotic system
- Robocath system demonstrates ability to efficiently and effectively support the full range of coronary interventions including in complex coronary artery disease patients
- Principal investigator, Dr. Nejjari, shared the findings during the “Innovations in Robotics for Transcatheter Heart Interventions” session at TCT on November 1, 2026
Stereotaxis has announced the findings from the first-in-human clinical results for Robocath’s next-generation robotic system during the Transcatheter Cardiovascular Therapeutics (TCT) conference in San Diego. The findings support a favorable performance profile for the system, with 100% clinical success rate and no device-related complications.
The study was conducted by Dr. Mohammed Nejjari and Dr. Franck Digne, Interventional Cardiologists at Centre Cardiologique du Nord (CCN) in Saint-Denis, France. This prospective pilot clinical study enrolled twenty patients undergoing PCI for coronary artery disease. Key findings from the study include:
- 100% clinical success and 95% technical success: All 20 patients met the study’s clinical success criteria of minimal residual stenosis post PCI. In all but one procedure the physician was able to complete the procedure entirely robotically without conversion to manual.
- No device-related adverse events: Clean safety profile with no intra-procedural vascular complications, major adverse events, or device related adverse events through 30-day follow-up
- No physician radiation exposure: Operating physicians performed the procedures entirely protected from fluoroscopy radiation, supporting the system’s potential to reduce occupational risk in interventional cardiology.
- Performance across lesion complexity: The study included A/B1, B2, and C-type lesions, representing three levels of procedural complexity, including in complex coronary disease in tortuous distal vasculature.
Dr. Nejjari discussed these findings during the November 1, 2026 scientific session “Innovations in Robotics for Transcatheter Heart Interventions” that took place at TCT. A manuscript documenting these findings has been submitted for publication and is under review.
“These initial findings mark an important milestone in the advance of robotic technology in interventional cardiology,” said Dr. Nejjari. “The results are very encouraging, particularly the clinical success and safety observed across the patient cohort including in complex PCI. We are excited for the potential of this robotic innovation to improve care for patients and benefit physician safety and workflow.
Robocath, a subsidiary of Stereotaxis, is a technology leader in pioneering advanced robotic innovations for interventional cardiology and neurointerventions. Robocath’s next-generation system builds on the clinical and technological experience of the first-generation R-One system, now used in centers worldwide. It adds advanced capabilities such as multi-device handling of up to five interventional devices simultaneously to support increasingly complex interventional procedures.
“These first-in-human results support our confidence in our innovation strategy and reflect our commitment to advancing differentiated robotic technologies across endovascular interventions,” said David Fischel, Chairman and CEO of Stereotaxis. “We look forward to building on these initial findings, progressing Robocath’s technology towards regulatory submissions, and delivering this promising technology to interventional physicians and patients suffering from coronary disease and stroke.”
Source: Stereotaxis