SirPAD Evaluates Concept Medical’s MagicTouch Sirolimus-Coated Balloon

April 1, 2026—Concept Medical Inc. announced the presentation of primary results of the SirPAD randomized controlled trial of the company’s MagicTouch sirolimus-coated balloon for percutaneous transluminal angioplasty (PTA) to treat peripheral artery disease (PAD). Professor Nils Kucher, MD, and Professor Stefano Barco, MD, are Principal Investigators and Cochairs of the SirPAD trial.

The data were presented by Prof. Barco at ACC.26, the American College of Cardiology’s annual scientific session, and simultaneously published by Prof. Barco et al in The New England Journal of Medicine.

According to Concept Medical, SirPAD is an academic, all-comers trial that enrolled 1,252 patients with femoropopliteal or below-the-knee PAD. The patients were randomized to receive either the sirolimus-coated MagicTouch PTA device or any uncoated balloon angioplasty device.

As summarized by the company, the primary outcome of major adverse limb events (encompassing major unplanned amputations affecting the target limb or target lesion revascularization for critical ischemia) occurred in 8.8% of patients enrolled in the sirolimus-coated balloon group versus 15% in the uncoated balloon group at 1 year, corresponding to a median unbiased estimate of risk difference of -4.9%. This difference was both noninferior and superior in favor of MagicTouch PTA versus the uncoated balloons, noted the press release.

Additionally, there was a statistically significant reduction in the composite key secondary endpoint of any unplanned target limb amputation or target limb revascularization, stated the company.

“We are excited about the primary outcome results of SirPAD,” commented Profs. Kucher and Barco in Concept Medical’s press release. “It is one of the very few trials in this field that successfully included an all-comers population, meaning consecutive patients without eligibility restrictions related to target lesion characteristics or PAD stage. This led to nearly 50% of enrolled patients having acute or chronic limb-threatening ischemia, thereby providing enough events and statistical power to demonstrate superiority for hard clinical outcomes at 1 year."

With this primary analysis of the SirPAD trial published, the company stated that there is proof of efficacy that a sirolimus drug-coated balloon improves clinical outcomes in an all-comers population, with potential impact on future guidelines.

Concept Medical noted that the earlier SIRONA randomized controlled trial confirmed the noninferiority of MagicTouch PTA in the femoropopliteal PAD versus paclitaxel drug-coated balloons. The SIRONA findings were announced in October 2024.