Lithotripsy Without Limits
LithiX™ Hertz Contact IVL (HC-IVL) Delivers Optimal Stent Expansion in Calcified Lesions
Each year, more than 2 million percutaneous coronary intervention (PCI) procedures are performed worldwide—and the number is growing1. However, PCI outcomes are at risk when coronary artery calcification (CAC) isn’t adequately addressed. Calcium can lead to stent under-expansion, vessel injury, and restenosis. With over 30% of PCI cases involving moderate to severe CAC2, effective lesion preparation is essential for procedural success and long-term outcomes.
LithiX™ Hertz Contact Intravascular Lithotripsy (HC-IVL) offers a new way to harness intravascular lithotripsy without the procedural complexity of generator-powered IVL systems.
How LithiX uses Hertz Contact Stress for Targeted Intravascular Lithotripsy
LithiX lithotripsy mechanism of action to create calcium fractures is based on the Hertz Contact Stress principle and does not require an external energy source.
LithiX utilizes a balloon catheter with multiple rows of unique metallic hemispheres. The hemispheres deliver discrete, focused stress on the calcified plaque without damaging the surrounding tissue—hard on calcium and soft on tissue.
The results:
Deep, wide calcium cracks
- The additional versatility to treat complex and diverse calcific lesion morphologies (eccentric, concentric, lesions with calcific nodules)
- Simplified procedure and technique
With this unique mechanism of action, LithiX HC-IVL is designed to enable optimal device expansion and lumen gain with an optimized procedure workflow in the catheterization lab.
Clinical Evidence Demonstrates the Safety & Effectiveness of LithiX HC-IVL
Clinically proven and designed for versatility, LithiX maximizes stent expansion while minimizing procedural complexity. Backed by clinical evidence, it delivers optimized stent expansion, safely and effectively—setting a new standard in vascular intervention.
The PINNACLE I Study of LithiX HC-IVL3
Researchers documented the results of LithiX treatment from a multi-center, prospective, non-randomized single arm study in PINNACLE I. With 60 patients enrolled, the study focused on safety, tracking MACE within 30 days of the procedure, and efficacy, defining clinical success as residual stenosis <50% after stenting.
clinical success†
angiographic success‡
Of the study population, 32 patients had additional OCT analysis. The study confirmed the mechanism of action, identifying deep calcium fractures in both eccentric and concentric calcified lesions.
of lesions with calcium fracture visible on OCT imaging
of lesions had multiple fractures
†Residual stenosis <50% with no in-hospital MACE through hospital discharge
‡ Stent delivery success, with residual stenosis <50% and no serious angiographic complications
§ in eccentric and concentric calcific lesions and those with calcific nodules
Examples of Calcium Fractures Visualized with OCT3
Eccentric Calcified Lesion
Pre-procedure
Post-LithiX HC-IVL
Final Post-stent
Concentric Calcified Lesion
Pre-procedure
Post-LithiX HC-IVL
Final Post-stent
Lesion with Calcified Nodule
Pre-procedure
Post-LithiX HC-IVL
Dr. Johan Bennett, M.D., principal investigator of the PINNACLE I trial (University Hospital Leuven, Belgium) commented on the 6-month LithiX HC-IVL results:
“The six-month PINNACLE I data are a strong validation of LithiX IVL’s mechanism of action that can safely fragment calcium across a range of complex morphologies without trauma to the soft tissue and can be easily integrated into standard PCI procedure workflow without the need for an energy source.”
Ready to Redefine Your Approach to Calcified Lesions?
Experience a breakthrough in coronary calcium treatment with LithiX HC-IVL. Backed by strong clinical evidence and powered by a novel Hertz Contact Stress mechanism of action, LithiX delivers optimized vessel preparation with a versatile approach and without the need for capital equipment. Join the growing number of interventional cardiologists embracing a more versatile, simplified approach to lesion preparation.
If you’d like to talk with someone to discuss how you can utilize LithiX in the treatment of your patients, contact us.
- Abubakar M, Javed I, Rasool H, et al. (July 03, 2023) Advancements in Percutaneous Coronary Intervention Techniques: A Comprehensive Literature Review of Mixed Studies and Practice Guidelines. Cureus 15(7): e41311. doi:10.7759/cureus.41311
- Guedeney P. , et al. Coronary calcification and long-term outcomes according to drug-eluting stent generation. J Am Coll Cardiol Intv. 2020
- Bennett J. TCT 66794: Hertz Contact Intravascular Lithotripsy (HC-IVL) for Treating Complex Calcific Lesions: PINNACLE I Clinical Trial Six-Month and OCT Procedural Imaging Outcomes. Presented at TCT 2024 on behalf of the PINNACLE I Investigators.
PMN 2194 Rev A