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PAD Trial Shows Sirolimus Balloon Superiority
1 Apr
Summary
- Sirolimus balloon trial significantly reduces major adverse limb events.
- Trial included diverse 'all-comers' patients with critical limb ischemia.
- MagicTouch sirolimus balloon shows promise as future PAD treatment.
The SirPAD trial, a significant randomized controlled study focusing on sirolimus-coated balloons for Peripheral Artery Disease (PAD), has revealed its primary outcomes. Presented at the ACC 2026 Scientific Sessions and published in the New England Journal of Medicine, the trial enrolled 1,252 patients with femoropopliteal or below-the-knee PAD.
Results indicate that the sirolimus-coated balloon, MagicTouch PTA, led to a 8.8% occurrence of major adverse limb events at one year, compared to 15% for uncoated balloons. This represents a statistically significant superiority in favor of the sirolimus-coated balloon. The trial's inclusion of an "all-comers" population, with nearly half experiencing critical limb-threatening ischemia, provided robust evidence for these favorable clinical outcomes.
These findings position the MagicTouch PTA as a potentially game-changing treatment alternative for PAD. The comprehensive data supports the efficacy of sirolimus-coated balloons in improving clinical outcomes, with the potential to influence future treatment guidelines and expand physician options for managing PAD.
