Concept Medical Inc. announced its MagicTouch PTA sirolimus-coated balloon significantly reduced major adverse limb events (MALE) by a relative 41% in patients with peripheral artery disease (PAD) compared to uncoated balloon angioplasty, according to primary results from the SirPAD trial presented at the ACC 2026 Scientific Sessions. The data, simultaneously published in the New England Journal of Medicine, showed the device could become a new standard of care.
"We are excited about the primary outcome results of SirPAD. It is one of the very few trials in this field that successfully included an all-comers population," said Principal Investigators Prof. Dr. med. Nils Kucher and Prof. Dr. med. Stefano Barco in a statement. "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 one year."
The trial enrolled 1,252 patients with femoropopliteal or below-the-knee PAD, making it the largest randomized controlled trial for a sirolimus-coated balloon. The primary outcome of MALE occurred in 8.8% of patients in the MagicTouch PTA group versus 15% in the uncoated balloon group at one year. This represents a median unbiased risk difference of -4.9%, meeting endpoints for both noninferiority and superiority. A key secondary endpoint, the composite of any unplanned target-limb amputation or revascularization, was also significantly reduced.
The positive results position the MagicTouch PTA balloon as a leading treatment alternative for PAD, a market with significant unmet needs. The data provides strong evidence for the efficacy of a sirolimus-coated balloon in a broad, real-world patient population, potentially influencing future clinical guidelines. This follows another recent study, the SIRONA RCT, which confirmed the non-inferiority of MagicTouch PTA against paclitaxel-coated balloons, a different class of drug-coated device. For Concept Medical, a private company, the strong clinical validation across multiple large trials could pave the way for regulatory approvals and rapid commercial adoption.
This article is for informational purposes only and does not constitute investment advice.
