Coronary lesion preparation · Contact IVL
VesSpiral® Ultra
A spiral twin-wall, super-high-pressure PTCA balloon that fractures calcified coronary lesions by contact, with no external energy source and no capital equipment.
The device, in detail
Low profile for easy crossing
Spiral twin-wall balloon design
- Unique balloon-in-spiral technology
- Withstands ultra-high pressure (36 atm RBP)
- No dog-boning
Integrated spiral components
- Uniformly distributed spirals minimize tissue injury and dissection
- No risk of component detachment
Contact intravascular lithotripsy (IVL)
- Amplified focal stress on the spiral convexity fractures calcified lesions
- No external energy source or equipment
Contact lithotripsy, by design.
VesSpiral Ultra is a non-compliant balloon inside a low-profile spiral balloon. Under low inflation, the spiral’s convex segments create highly localized points of contact with calcium and amplify force to create deep, wide fractures through a Hertz contact-stress mechanism. As pressure increases, the concave segments expand outward to continue fracturing the lesion, so the vessel dilates uniformly and injury is minimized. Indicated for pre-dilatation and post-deployment expansion of balloon-expandable coronary stents.
Why it’s different
01
Ultra-high pressure, no dog-boning
A double-balloon design withstands ultra-high pressure up to 36 atm RBP to prepare most calcified lesions, without the dog-boning of a conventional balloon.
02
Highly non-compliant
Less than 10% radial growth over nominal diameter even at 36 atm, for controlled, predictable expansion.
03
Contact IVL, no capital equipment
The integrated spiral delivers contact intravascular lithotripsy with no external energy source and no generator to buy, install, or maintain.
04
Integrated spiral, nothing to detach
The spiral is formed into the balloon rather than bonded on, keeping a low crossing profile with no scoring components that can detach.
Near-linear, highly non-compliant.
Precise expansion of underexpanded stents.
Its linear compliance and ultra-high pressure let VesSpiral Ultra expand an underexpanded stent precisely after deployment.
Mean lumen diameter 2.87 mm → 3.03 mm after expansion.
Specifications
- Platform
- Rapid exchange (Rx)
- Balloon material
- PA
- Marker material
- Platinum-Iridium
- Tip design / profile
- Taper, 0.016 in
- Distal shaft diameter
- 0.95 ± 0.05 mm
- Proximal shaft diameter
- 0.68 ± 0.05 mm
- Compliance
- Non-compliant
- Nominal pressure (NP)
- 12 atm
- Rated burst pressure (RBP)
- 30–36 atm
- Catheter shaft length
- 140 ± 5 cm
- Guidewire compatibility
- 0.014 in
- Min. guiding catheter ID
- 6F
- Shelf life
- 36 months
Sizes
- 1.00
- 1.25
- 1.50
- 1.75
- 2.00
- 2.50
- 3.00
- 3.50
- 4.00
- 5
- 10
- 15
- 20
All sizes are CE marked.
VesSpiral® Ultra 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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