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Drug intelligence / Profile preview
Sundance Sirolimus DCB
- Development stage
- Unknown
- Lead developer
- SurModics
- Modality
- Small Molecules
- Administration
- Intra-arterial
01
Overview
The Sundance Sirolimus DCB (Drug-Coated Balloon) is an investigational medical device developed by Surmodics, Inc. for the treatment of occlusive disease in the infrapopliteal (below-the-knee) arteries. The device utilizes a next-generation coating technology that combines microcrystalline sirolimus with a proprietary excipient to optimize drug transfer and maintain therapeutic levels in the arterial wall during and after balloon dilatation. Sirolimus, the active pharmaceutical ingredient, is a potent anti-proliferative and anti-inflammatory small molecule that inhibits the mechanistic target of rapamycin (mTOR), thereby preventing the cellular proliferation that leads to restenosis. The Sundance Sirolimus DCB is currently being evaluated in the SWING trial, a first-in-human feasibility study involving patients with stenotic or occluded lesions of the infrapopliteal arteries.
- Brand names
- Sundance Sirolimus DCB
- Other names
- Sundance DCBSurmodics Sirolimus DCB
02
Targets
FKBP1AMechanistic target of rapamycin complex 1
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