Drug-coated balloon · Sirolimus
SuperFlow™
A sirolimus-coated spiral balloon catheter for coronary drug delivery.
The device, in detail
A spiral balloon platform and a nano-lipid drug coating, working together on one balloon.
Spiral balloon platform
- Integrated anti-slip spiral
- Enhanced drug delivery and transfer
- Safe, controlled dilation
- Low profile for easy crossing
Nano-lipid (LNP) drug coating
- Less drug push-loss
- Enhanced drug transfer
- Sustained release to 21 days
- Precision drug loading
A spiral balloon that carries the drug.
SuperFlow combines a spiral drug-delivery balloon with a polymer-free nano-lipid sirolimus coating. The spiral platform dilates the vessel at low pressure and grips the wall, so the balloon resists slippage and loses less drug on the way to the lesion.
The nano-lipid coating is absorbed quickly by the vessel wall, then releases sirolimus in a sustained way for up to 21 days. Together they give a firm, uniform coating, precise dosing, low drug loss during delivery, and high transfer during dilation.
Why it’s different
Spiral balloon platform
Integrated anti-slip spiral
The spiral grips the vessel wall to prevent slippage and reduce drug loss during dilation.
Enhanced drug transfer
Low-pressure, controlled dilation improves contact and drug transfer to the wall.
Safe, controlled dilation
Semi-compliant expansion for predictable, uniform vessel dilation.
Low crossing profile
A low profile for easy crossing of tight and tortuous anatomy.
Nano-lipid (LNP) drug coating
Less drug push-loss
A firm, uniform coating keeps more of the drug on the balloon until it reaches the lesion.
Enhanced drug transfer
The nano-lipid carrier is absorbed quickly by the vessel wall during dilation.
Sustained release
Polymer-free sirolimus released in a sustained way for up to 21 days.
Precision drug loading
Controlled, uniform loading for consistent, precise dosing.
Preclinical findings
In a preclinical (animal) study, SuperFlow lost less drug on the way to the lesion, transferred more drug to the vessel wall during dilation, and released sirolimus in a sustained way over 21 days, compared with a paclitaxel-coated balloon.
Drug transfer to the vessel wall during dilation was higher for SuperFlow (1.20%) than the comparator (0.79%).
Preclinical, in-vivo animal data; not a clinical outcome. Comparator is a paclitaxel-coated drug balloon. For research and informational purposes; refer to the labeling for approved indications and use.
At a glance
- Device
- Sirolimus-coated spiral balloon
- Balloon
- Semi-compliant, spiral
- Coating
- Polymer-free nano-lipid sirolimus
- Drug release
- Up to 21 days
- Guidewire compatibility
- 0.014 in
Full specifications and sizes available on request.
Availability
SuperFlow™ is CE marked and available in the European Union. In the United States, it is not yet available for sale and has not been cleared by the FDA; US introduction is planned. Physician-directed use (Rx); refer to the labeling supplied with the device for indications, contraindications, warnings, and instructions for use.
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