Biotronik AG

- The phase 3 SirPAD trial randomized 1,252 patients with symptomatic infrainguinal peripheral artery disease to sirolimus-coated or uncoated balloon angioplasty. - At one year, the primary composite endpoint of major target-limb amputation or target-lesion revascularization for chronic limb-threatening ischemia occurred in 8.8% versus 15%. - The key secondary composite endpoint of any unplanned amputation or revascularization occurred in 23% with sirolimus-coated balloons versus 30.8% with uncoated balloons. - One-year all-cause mortality was similar between groups at 11.8% versus 12.8%, offering short-term safety reassurance for the sirolimus platform.

Jun 30, 2026

Back to Organizations

Biotronik AG

Overview

Trial Phase Distribution

Trial Status Distribution

Clinical Trials

Trials sponsored by this organization (46)

Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System in the Treatment of Subjects With Long de Novo Lesions

Prospective, Multicenter, Single-Arm Observational Study to Confirm the Safety and Clinical Performance of the Oscar Peripheral Multifunctional Catheter for the Dilatation of Lesions in the Femoral, Popliteal and Infrapopliteal Arteries (BIO-OSCAR First)

Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System

Evaluation of Standard of Care Practices, Procedural Outcomes and In-hospital Complications of Peripheral Endovascular Procedures

BIOTRONIK Dynetic-35 Stent for the Treatment of Peripheral Iliac Lesions

Resorbable Magnesium Scaffolds Registry

BIOFLOW-VIII All-comers Orsiro Mission Safety and Performance Registry

First in Men Study: BIOMAG-I

Approvals

News

SirPAD: Sirolimus-Coated Balloons Cut Amputation and Revascularization in Infrainguinal PAD