Concept Medical, Inc.

Sirolimus-Coated Balloons Show Promise in PAD Treatment: SIRONA Trial Results

5 months ago

• The SIRONA RCT demonstrated that sirolimus-coated balloons (MagicTouch PTA) achieve similar patency and functional benefits compared to paclitaxel-coated balloons in PAD patients. • The trial, involving 482 patients, showed a primary patency of 73.8% with MagicTouch PTA versus 75% with paclitaxel DCBs, meeting the non-inferiority endpoint. • SIRONA also revealed a favorable safety profile for sirolimus-coated balloons, with no significant difference in clinically-driven target lesion revascularization at 12 months. • Concept Medical's MagicTouch PTA sirolimus-coated balloon is also under investigation in the SIRPAD trial, the world's largest RCT for PAD treatment, with over 1,250 patients enrolled.

SIRONA Trial Completes Enrollment, Evaluating Sirolimus DCB for Peripheral Artery Disease

3 years ago

• The SIRONA trial, a head-to-head RCT, has completed enrollment of 480 patients across Germany and Austria, investigating sirolimus-coated balloons (Magic Touch PTA) versus paclitaxel-coated balloons for femoropopliteal peripheral artery disease. • The trial assesses the safety and efficacy of sirolimus DCB in patients with superficial femoral artery disease, including de-novo and restenotic lesions, and Rutherford classes 2-4. • Primary outcomes include patency at 12 months (absence of target lesion revascularization or restenosis) and a composite safety endpoint of freedom from device/procedure-related death or major target limb amputation. • Results from SIRONA are anticipated to influence the adoption of sirolimus DCBs in treating peripheral artery disease, potentially shifting the treatment paradigm from paclitaxel-coated devices.