The LithiX™ Hertz Contact Lithotripsy (HC-IVL) Catheter is a next-generation mechanical intravascular device designed to treat moderate to severely calcified coronary artery lesions. Unlike traditional energy-based IVL systems, LithiX uses localized Hertz contact stress applied via precision-engineered metal hemispheres on a semi-compliant balloon to fracture calcium deposits while preserving soft vascular tissue.
Its innovative mechanical approach eliminates the need for external energy sources or generators, simplifying cath lab workflow and reducing procedural complexity.
Key Features & Benefits
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Mechanical Hertz Contact Lithotripsy : No external power source required
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Semi-Compliant Balloon : Ensures controlled inflation and optimal vessel preparation
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Localized Contact Force : Precisely targets calcified plaque without damaging surrounding tissue
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Broad Calcium Modification : Effective for eccentric, concentric, and nodular calcification
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Improved Stent Expansion : Facilitates optimal stent deployment and lumen gain
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Streamlined Workflow : Easy integration into standard PCI procedures
Mechanism of Action
Positioning: The catheter is advanced to the site of the calcified lesion.
Balloon Inflation: The semi-compliant balloon inflates, pressing stainless-steel hemispheres against the plaque.
Hertz Contact Force Application: Localized high-pressure contact fractures calcium deposits.
Result: Deep, wide calcium cracks enable optimal vessel expansion and stent deployment.
Clinical Evidence
PINNACLE I Trial: Demonstrated high procedural success rates and robust calcium fracture patterns across multiple lesion morphologies.
Stent Expansion: OCT imaging confirmed >100% mean stent expansion in both eccentric and concentric lesions.
Safety: No significant vessel injury to surrounding soft tissue reported.
Regulatory Status: CE Mark approved; commercially available in select European markets.
Pre-procedure
Post-LithiX HC
Final Post-stent
