Hertz Contact Intravascular Lithotripsy is a generator-free, catheter-based system to modify (crack) calcium deposits in the arterial wall. It's mechanism of action is based on the physics principles of Hertz contact stresses, allowing for optimal vessel preparation and stent expansion while maintaining patient safety and operator ease of use.

Unlike generator-dependent IVL, which requires an external energy source to generate mechanical force via explosive cavitation waves, Hertz Contact IVL selectively generates >6-10 times amplification of mechanical force from metallic hemispheres on hard materials, such as calcium, while remaining soft on tissue.

The clinically important advantages of HC-IVL are:

• Versatility: Effective against a wide spectrum of calcium morphologies including eccentric and concentric calcium, and calcified nodules.  Access and treat multiple vessels and long lesions with a single LithiX™ HC-IVL catheter.  Confidently engage diverse anatomy – tortuous, bifurcations, small vessels.
• Deliverability: Low crossing profile and device flexibility allow for navigation through tortuous or narrow vessels and beyond severe angulation.
• Workflow efficiency: Generator-free design allows for shelf-to-patient efficiency and simplified, safe technique.

HC-IVL improves stent expansion by modifying calcified plaque before stent placement, which is essential for successful PCI outcomes.

Key benefits include:

• Improved lesion compliance: Calcium fractures allow the vessel to expand more easily
• Enhanced stent expansion: Reduces the risk of underexpanded stents
• More uniform stent apposition: Supports better contact with the vessel wall
• Improved long-term outcomes: Optimal expansion is associated with lower rates of restenosis and stent thrombosis

Effective calcium modification prior to stenting is a critical step in achieving durable PCI results, and HC-IVL provides a controlled and predictable way to prepare the vessel.

LithiX™ Hertz Contact IVL (HC-IVL) is supported by a growing body of clinical evidence, including prospective studies such as the MY-IVL post-market study and PINNACLE I clinical trial, which evaluated its safety and effectiveness in treating calcified coronary lesions.

MY-IVL Study²
The MY-IVL study evaluates the performance of HC-IVL in a real-world population with calcified coronary artery disease undergoing PCI. The study focuses on key procedural outcomes such as:

• Successful lesion preparation
• Stent expansion
• Device safety

Results demonstrate effective calcium modification and favorable safety profile in real-world practice, supporting the use of HC-IVL for lesion preparation in calcified lesions in complex anatomy and calcium morphologies.

PINNACLE I Study¹
The PINNACLE I clinical study aimed to assess the LithiX lithotripsy device, which uses the Hertz Contact stress mechanism of action to fragment calcium while minimizing injury to surrounding soft tissue, without requiring an external energy source.

• Acute procedural success
• Device-related safety endpoints
• Clinical outcomes following PCI

Findings from PINNACLE I show the ability of HC-IVL to deliver controlled and effective calcium modification while maintaining a strong safety profile.

Clinical significance
Together, these studies demonstrate that HC-IVL provides:

• Effective modification of calcified plaque across calcium morphologies including eccentric, concentric, and nodules and heterogeneous calcium
• Improved vessel compliance for stent delivery and expansion
• A predictable and safe approach to lesion preparation

This growing evidence base supports HC-IVL as an important advancement in the treatment of calcified coronary artery disease.

HC-IVL is designed to treat a broad range of calcified coronary lesions.

Clinical studies^1,2 have shown it to effectively treat:

• Concentric calcium
• Eccentric calcium
• Nodular calcium
• Thick calcium
• Heterogeneous calcium

LithiX™ HC-IVL does not require any special equipment. LithiX™ HC-IVL is powered by a standard indeflator to exert Hertz Contact stresses, resulting in >6-10 times amplification of force from metallic hemispheres onto hard calcium while remaining soft on tissue.

Prospective clinical studies show LithiX™ HC-IVL is associated with a highly favorable safety profile.

Clinical studies show LithiX™ HC-IVL is designed to be hard on calcium and soft on tissue, with consistent optimal stent expansion and no perforations or severe dissections.^1,2

Safety Outcome	PINNACLE I (n=60, L=63)	MY-IVL (n=96)
Any severe dissection	0 (0.0%)	0 (0.0%)
Any perforation	0 (0.0%)	1 (1.0%): One subject had perforation occuring during stent deployment (not HC-IVL-related)
Any abrupt closure	0 (0.0%)	0 (0.0%)
Any no-reflow	0 (0.0%)	0 (0.0%)
Any thrombus	0 (0.0%)	0 (0.0%)
Any spasm	0 (0.0%)	0 (0.0%)
Any distal embolism	0 (0.0%)	0 (0.0%)

Clinical studies and post-market use show the LithiX™ HC-IVL system, which unlike generator-dependent IVL is not pulse-count limited, is designed for repeated inflations to safely and effectively crack calcium even in long calcific lesions to allow for optimal stent expansion.^2,3