CE-FDA-NMPA VesSpiral® Coronary Spiral Balloon Catheter The Game Changer of Balloon Dilation

VesSpiral® is a semi-compiiant rapid exchange catheter with SPIRAL balloon. The spiral elements are integrated and uniformly distributed on the balloon surface during balloon forming. The catheter is used for coronary arteries dilatation with unique programed dilation mechanism which is more safe and effective than that of both Plain and Scoring balloons. Plain balloons, being cylindrical shaped and smooth surface, achieve vessel expansion by applying consistent pressure to all surround intima tissue as the balloon inflated. Clinically, this consistent dilation often results in vessel intima...

Spiral Balloons VesSpiral®Coronary Spiral Balloon Catheter Low Profile for Easy Crossing Integrated Spiral Components • No risk of components detachment -® Programed Dilation: •Saferduringdilation • Minimizes tissue injury ®- Uniform, Micro-dilation • Avoid dissection • Faster healing Enhanced Drug Delivery & Transfer

In both plain and scoring balloons, the balloon stress rises linearly as pressure increases, resulting in vessel gain, but also leading to complications such as intimal tear or dissections, particularly in scoring balloon, in which, the stress on the scoring components is significantly higher than on balloon surface. The VesSpiral® Coronary Spiral Balloon Catheter features spiral raised and depressed segments. At the beginning of inflation, the force is focused primarily on the raised segments, anchoring the balloon into the lesion tissue and dilation at low pressure (4ATM). As the pressure increases,...

Balloon displacementduringexpansion isa common issue in PCI procedures, particularly in diffused atherosclerotic or calcified plaques. Displacement can lead to inaccurate expansion and vascular wall injury. The grooves on the surface of the spiral balloon, similar to tank continuous tracks, significantly increase friction between the balloon and the vessel wall, as the pressure increases, these grooves gradually flatten and eventually resemble a regular balloon (figure 3). Figure 3: The depth of the spiral on the balloon gradually flattens as inflation pressure increases, resulting in evenvascularstrain...

Plain balloons and Spiral balloons (N=6 per group) were randomly implanted into porcine coronary arteries. Coronary artery tissues were extracted at 24 hours, 7days, 28daysand 90 days post-implantation. The results are: neointima formation occurred in 24hourgroup(Plain vs. Spiral) is 2 vs.0,7days group is 4 vs. 1,21 day group is 6 vs.2,90day group is 6 vs.l. These findings indicate that the Spiral balloon causes significantly less damage to blood vessels during dilation than the conventional balloon does(figure 7).

Spiral Balloons Order Information re CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can befound in the product labelingsuppiied with each device. VesSpiral® is a trademark or registered trademark of TT Medical

o Better everyday oManufacturer: TT Medical, Inc. Rm. 501, Bldg. l,Songshan Lake National High-Tech Park, Dongguan, Guangdong, E-mail: [email protected] Document No.: TT-PTCA-VSP-BR-EN Rev.1.0 Approval Date: 2025.09.01