GREAT Pivotal Trial of Nipro’s Golazo Peripheral Atherectomy System Completes Enrollment

October 7, 2026 – Nipro Corporation announced that its United States subsidiary, Nipro Vascular Innovations Americas, Inc. (NVIA), has completed enrollment in the GREAT pivotal trial evaluating the safety and effectiveness of the investigational Golazo peripheral atherectomy system for the treatment of symptomatic lower extremity peripheral artery disease (PAD).

According to Nipro, the investigational Golazo system is a rotational, front-cutting atherectomy catheter intended for the removal of both fibrocalcific and viscoelastic plaque.

Nipro stated that the enrollment completion advances the Golazo clinical development program toward NVIA’s planned 510(k) premarket notification submission FDA. The submission will include the analysis of endpoints for the full study cohort from the GREAT trial.

The company is targeting commercial availability in the United States in 2028, subject to successful completion of the study and regulatory review.

The GREAT trial is an FDA-approved investigational device exemption pivotal study. The prospective, multicenter, single-arm study enrolled 158 patients at clinical centers in the United States. Follow-up evaluations will be conducted at 30 days and 6 months after treatment, noted the press release.

Robert E. Beasley, MD, is Principal Investigator of the GREAT trial.

“Effective plaque modification and vessel preparation remain important goals in the treatment of PAD,” commented Dr. Beasley in the company’s press release. “With enrollment now complete, we look forward to evaluating the complete clinical data set and assessing the safety, handling characteristics, and procedural performance of the Golazo system across a broad range of lesion types.”