FIH Results Reported for Robocath’s Next-Generation Robotic System for PCI

November 4, 2026—Stereotaxis announced first-in-human (FIH) results from a prospective pilot study evaluating Robocath’s next-generation robotic system for percutaneous coronary intervention (PCI). The study enrolled 20 patients with coronary artery disease and reported 100% clinical success and 95% technical success.

Principal Investigator Mohammed Nejjari, MD, presented the findings at TCT 2026 in San Diego, California.

Dr. Nejjari and Franck Digne, MD, conducted the study at Centre Cardiologique du Nord in Saint-Denis, France. The cohort included patients with types A/B1, B2, and C lesions, including complex coronary disease involving tortuous distal vessels.

According to Stereotaxis, all 20 patients met the study’s clinical success criteria of minimal residual stenosis after PCI. Nineteen procedures were completed entirely robotically, with one requiring conversion to manual intervention.

The company reported no intraprocedural vascular complications and no major adverse events or device-related adverse events through 30-day follow-up. Operating physicians performed the procedures while protected from fluoroscopy radiation, according to the press release.

“These initial findings mark an important milestone in the advance of robotic technology in interventional cardiology,” commented Dr. Nejjari in the company’s press release. “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.”

The next-generation platform builds on Robocath’s R-One system and can handle up to five interventional devices simultaneously. A manuscript describing the pilot study has been submitted for publication and is under review.

“These FIH results support our confidence in our innovation strategy and reflect our commitment to advancing differentiated robotic technologies across endovascular interventions,” added David Fischel, Chairman and CEO of Stereotaxis. “We look forward to building on these initial findings, progressing Robocath’s technology toward regulatory submissions, and delivering this promising technology to interventional physicians and patients suffering from coronary disease and stroke.”

Robocath is a subsidiary of Stereotaxis.