BD’s Rotarex to Treat CLTI Evaluated in Interim Findings from XTRACT Registry 

October 16, 2026—Interim findings from the prospective, international XTRACT registry for the Rotarex rotational excisional atherectomy system (Becton, Dickinson and Company [BD]) in patients with chronic limb-threatening ischemia (CLTI) were presented by Prakash Krishnan, MD, at VIVA 2026, the Vascular Interventional Advances conference.

XTRACT is a prospective, multicenter, single-arm postmarket study evaluating the safety and effectiveness of the Rotarex system in patients with peripheral artery disease. BD announced the first patient enrollment in the registry in October 2025.

The VIVA press release reported that the XTRACT registry aims to enroll approximately 600 patients across two cohorts: acute limb ischemia and CTLI. The primary endpoints include procedural success, defined as successful target lesion revascularization with residual stenosis or thrombus ≤ 30%, and freedom from a composite of device- and/or procedure-related perioperative death, unplanned major target limb amputation, and clinically driven target lesion revascularization at 30 days.

Technical success is defined as reduction of residual stenosis and creation of an optimal working channel for adjunctive therapies.

As summarized by VIVA, the data are from 102 patients with CLTI (mean age, 69.7 years; women, 42.2%) who underwent treatment with the Rotarex system (130 lesions treated overall) at nine investigational sites between September 2025 and June 2026.

The patients’ lesion characteristics included the following:

• Rutherford class 3 (37.3%) or class 4 (34.3%) disease
• More than 20% underwent treatment of ≥ 2 target lesions
• Mean lesion length, 126.5 mm.
• 54.6% of the treated lesions were de novo, and 26.9% involved in-stent restenosis.
• The superficial femoral artery was involved in 80% of lesions, and the popliteal artery in 30%

Additionally, all 102 patients underwent adjunctive procedures after Rotarex treatment, including drug-coated balloon angioplasty in 18.5% and plain old balloon angioplasty in 91.5%, noted the VIVA press release.

VIVA reported that in the XTRACT interim findings, technical success was achieved in 89.2% of patients, with device-related distal embolization occurring in 0.98% and no device-related major flow-limiting dissections reported. Freedom from the primary safety composite through 30 days was 98.0%.

Enrollment in the XTRACT registry remains ongoing with additional follow-up expected to provide further data on procedural outcomes and safety across patient subgroups and lesion characteristics, stated VIVA.