Medtronic Announces Subgroup Analysis Data From Atherectomy SLR

April 24, 2025—Medtronic announced the release of data from a subgroup analysis of an atherectomy systematic literature review (SLR) that is evaluating the safety and effectiveness of atherectomy in a range of patient and lesion cohorts.

The company noted that the SLR is a comprehensive evaluation of the utility of atherectomy for peripheral endovascular intervention to date and was completed through partnership with leaders in the peripheral vascular community. The analysis identified 305 original research articles reporting outcomes on atherectomy for endovascular treatment of occlusive or stenotic disease in infrainguinal peripheral arteries through May 2024.

Professor Thomas Zeller, MD, delivered results from the subgroup analysis in a podium-first presentation at the Charing Cross International Symposium 2025, held April 23-25 in London, United Kingdom. Prof. Zeller is with the University Heart Center Freiburg in Bad Krozingen, Germany.

According to Medtronic, the subgroup analysis data found that atherectomy was similarly safe and effective for both above-the-knee (ATK) and below-the-knee (BTK) peripheral artery disease, in patients with both chronic limb-threatening ischemia (CLTI) and claudication and in lesions with varying degrees of severe calcification, with similar patency and target lesion revascularization (TLR) rates across these cohorts.

The company reported that the major amputation and mortality rates after atherectomy were very low in studies with CLTI in < 50% of patients (0.8% and 1.9%, respectively) and in ATK disease (0.6% and 2.3%, respectively). Rates were acceptably low in studies with CLTI in ≥ 50% of patients (4.7% and 6%, respectively) and in BTK disease (5.7% and 5.6%, respectively).

Additionally, low provisional stenting rates were observed across all subgroups (3.4% to 10.7%), with very low provisional stenting rates in BTK disease (3.4%). Medtronic advised that it does not have any approved stents for use in infrapopliteal arteries.

As stated in the Medtronic press release, Prof. Zeller concluded, “The data from this review support the use of atherectomy as part of the endovascular treatment algorithm across a range of appropriately selected patient and lesion cohorts.”

The company noted that these results come after earlier findings demonstrating the safety and effectiveness of atherectomy with low rates of 12-month patency loss (23.9% across 47 studies), TLR (15.8% across 65 studies), major amputation (1.7% across 70 studies), mortality (2.8% across 63 studies), and bailout stenting (9.3% across 124 studies). Those findings were presented at VIVA24, held by The VIVA Foundation on November 3-6 in Las Vegas, Nevada, as well as at LINC 2025, held January 28-30 in Leipzig, Germany.

The Medtronic-sponsored “Roundtable Discussion on the Current State of Atherectomy for Lower Extremity Arterial Disease” with Jeffrey Carr, MD; Ralf Langhoff, MD; and Eric A. Secemsky, MD, was published in the January 2025 edition of Endovascular Today. Drs. Carr, Langhoff, and Secemsky comprised the steering committee that led the SLR and meta-analysis.