CE-NMPA VesSpiral® Ultra SpiralTwin-Wall Ultra High Pressure PTCA Balloon The Contact IVL for Complex Calcified Lesions

VesSpiral® Ultra is a Rapid Exchange Spiral Twin-Wall super high-pressure balloon catheter. The Spiral Twin-Wall balloon comprised of a noncompliance balloon inside a low profile spiral balloon, making the balloon highly noncompliantand super high pressure. The spiral elements are integrated and uniformly distributed across the balloon surface during balloon forming. Under low inflation, the convex of Spiral create highly localized points of contact with calcium and amplification of force to create deep and wide fractures based on Hertz Contact Stress mechanism, with inflation pressure increased,...

Spiral Balloons VesSpiral® UltraSpiral Twin-Wall Ultra High Pressure PTCA Balloon Integrated Spiral Components • Uniformly distributed spirals minimize tissue injury&dissection. SpiralTwin-Wall Balloon Design • Unique balloon-in-spiral balloon technology •Withstand ultra high pressures(36RBP) ■Amplified super-high focal stresses on spiral convexity to fractures calcified lesions • No external energy source or equipment required

Due to double balloon design, the VesSpiral® Ultra can withstand super high pressures up to36RBP-- the pressure is high enough to break most of calcified lesions and without undesirable dog-boning effect. - Highly Non-compliant VesSpiral® Ultra device has less than 10 radial growth over nominal diameter even when inflated up to 36 atm, make the device is extremely safe comparing with semi-compliant and Non-compliant balloons. The highly non-compliant of VesSpiral® Ultra device has a fat linear compliance chart due to its double balloon design

In VesSpiral® Ultra's balloon, the spiral component is integrated and uniformly distribute on balloon surface. During inflation, the convex of Spiral create highly localized points of contact with calcium and amplification of force to create deep and wide fractures based on Hertz Contact Stress mechanics. With inflation pressure increased, the concave of Spiral expanded outward, continuing fracture the remaining calcified lesion.This Spiral balloon's unique programed dilation mechanism make vessel dilated uniformly, the injury minimized and no need external energy source or capital equipment-simple...

Due to its linear compliance and ultra-high pressure, VesSpiral® ultra can effectively and precisely expand the underexpanded stent post stent deployment expansion. © Order Information VesSpiral® Ultra Spiral Twin-Wall Super High Pressure PTCA Balloon Order Information

TT Medical, Inc. is a fast-growing medical device company, dedicated ininnovative interventional device R&D, manufacturing & global marketingin the field of cardiovascular, neurovascularand and peripheral arterial disease. Mission: To provide solutions for innovative interventional technologies. We promise for Life. Innovation: The company has advance R&D facility located inside M2D2 (Massachusetts Medical Development Center, UMass Lowell), Boston, MA, and University of Massachusetts Lowell, Plastic Engineering Department. We make innovative device only! Advance Mf. & QMS: TT Medical has established...

o Better everydayo Manufacturer: TT Medical, Inc. Rm. 501, Bldg. l,Songshan Lake National High-Tech Park, Dongguan, Guangdong, E-mail: [email protected] Document No.: TT-PTCA-3VSP-BR-EN Rev.1.1 Approval Date: 2025.11.05