Virtue SAB

Virtue SAB is an investigational combination drug-device designed for the treatment of artery disease, specifically targeting coronary in-stent restenosis (ISR), coronary small vessel disease, and peripheral artery disease below-the-knee. It utilizes a proprietary extended-release formulation of sirolimus (SirolimusEFR) delivered via a non-coated microporous angioinfusion balloon. This design enables protected delivery and sustained focal release of therapeutic levels of sirolimus directly to the arterial wall during angioplasty without leaving any permanent implant or coating behind. The device aims to overcome limitations associated with traditional drug-coated balloons by ensuring consistent dosing and reducing risks such as downstream ischemia from particulate emboli. Preclinical and clinical data demonstrate that Virtue SAB maintains therapeutic tissue concentrations of sirolimus for approximately 30 days—the critical healing period—resulting in promising safety and efficacy outcomes in trials such as the European SABRE study. The device has received FDA Breakthrough Device Designation for multiple vascular indications and is currently being evaluated in pivotal U.S. clinical trials[1][2][4][5][6][7][9].

Brand names

Virtue SAB

Other names

Sirolimus AngioInfusion BalloonSirolimusEFR AngioInfusion Balloon