Coronary Intervention

LithiX™ HC-IVL

Hertz Contact Intravascular Lithotripsy for Calcified Coronary Lesions

The LithiX™ Hertz Contact IVL balloon catheter is designed for the treatment of severely calcified coronary lesions in patients with coronary artery disease (CAD). It enables targeted calcium modification and supports lesion preparation prior to PCI, balloon dilatation, or stent implantation.

Mechanical Generator-independent IVL for heavy calcium modification

LithiX™ uses precisely arranged metallic hemispheres to generate localized Hertz Contact Stress. This mechanical energy creates controlled fractures in calcified plaque, supporting effective coronary lesion preparation before balloon dilatation or stent deployment without the need for an external energy source.¹

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Versatile

For various calcification types (eccentric, concentric, and nodular) and supports consistent lesion preparation for optimal stent implantation.¹

Easy to use

A simplified workflow without external energy sources or an IVL generator enables efficient procedures, reduces complexity, and may lower cath lab resource needs.

Safe and effective

Only 1.7% MACE within 30 days and residual stenosis below 30% across all treated lesions in the PINNACLE-1 study.¹

Intravaskuläre Lithotripsie bei kalzifizierten koronaren Läsionen

Der HC-IVL Ballonkatheter LithiX™ dient der Behandlung stark kalzifizierter koronarer Läsionen im Rahmen der koronaren Herzkrankheit (KHK). Er wird zur Kalziummodifikation komplexer koronarer Gefäße eingesetzt und unterstützt die Läsionsvorbereitung für PCI, vor Ballondilatation oder Stentimplantation.

Hertz Contact Technologie: Mechanische Kalziummodifikation ohne externen IVL-Generator

LithiX™ nutzt präzise angeordnete metallische Halbkugeln zur Erzeugung von lokalem Hertz Contact Stress. Die mechanische Energie erzeugt gezielte Frakturen in kalzifizierten Plaques und unterstützt die koronare Läsionsvorbereitung für Ballondilatation oder Stentimplantation – ohne externe Energiequelle.¹

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Guidewire Lumen

Central lumen for precise advancement of the guidewire through the lesion.

Hemispheres

Concentrate mechanical stress on calcified plaque without a generator.

Inflation Lumen

Inner lumen enabling precise control of balloon inflation.

Balloon

Semi-compliant balloon allowing controlled dilation at low pressure.

Distal Tip

Soft, atraumatic tip designed for safe vessel entry.

Catheter Shaft

Flexible, reinforced shaft providing excellent pushability and manoeuvrability.

Clinical Evidence

Reliable Outcomes with LithiX™ HC-IVL: PINNACLE 1.

LithiX™ HC-IVL enables effective calcium modification in severely calcified coronary lesions and consistently achieves complete stent expansion while maintaining a strong safety profile.

In a multicentre study of 60 patients, LithiX™ demonstrated:

High safety profile (only 1.7% in-hospital MACE monitored within 30 days¹)
High efficacy (<30% residual stenosis in 100% of treated lesions¹)

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Clinical Success*

Angiographic Success**

32 patients from the study cohort underwent an additional OCT analysis. The data confirmed the mechanism of action and identified deep calcium fractures in both eccentric and concentric calcified lesions.

>94%

of lesions with visible calcium fractures on OCT imaging

75%

of lesions showed multiple fractures

>100%

mean final stent expansion in the OCT subgroup^§

Real-World Experience with LithiX™

SEVERE ANGULATION (LM/LCX) Case 1

Treatment of a severely calcified coronary artery

Before LithiX™ treatment

Final outcome

Before LithiX™ treatment

Final outcome

Multivessel disease with severe calcification Case 2

Treatment successfully completed with a single LithiX™ device

SCHWERE ANGULATION (LM/LCX) Fall 1

Behandlung einer stark verkalkten Koronar-arterie

Vor Einsatz von LithiX

Endergebnis

MEHRGEFÄSS-ERKRANKUNG MIT AUSGEPRÄGTER VERKALKUNG Fall 2

Erfolgreiche Behandlung mit nur einem LithiX-Gerät

Vor Einsatz von LithiX

Endergebnis

Clinical Evidence

Reliable Results with LithiX™ HC-IVL: Pinnacle-I

The PINNACLE I Clinical Study

The PINNACLE I clinical study evaluates the safety and performance of the LithiX™ Coronary Hertz Contact intravascular lithotripsy catheter for the treatment of moderately to severely calcified coronary lesions. Calcium fragmentation is achieved via Hertzian contact stresses delivered by the LithiX™ HC-IVL catheter.

Study Design

The study is multicenter, prospective, non-randomized, and single-arm. Up to 60 patients are enrolled. An imaging sub-study includes n = 32 patients.

Endpoints

Primary safety endpoint: MACE within 30 days (cardiac death, myocardial infarction, and TVR).
Primary efficacy endpoint: Procedural success, defined as residual stenosis <50% after stent implantation without in-hospital MACE.

Follow-up assessments are conducted at 30 days and 6 months.

Key Results

The PINNACLE I study demonstrates the safety and efficacy of LithiX™ Hertz Contact IVL for calcium fragmentation across a broad spectrum of complex calcified morphologies.

A total of 98.3% of patients achieved the primary safety and efficacy endpoint (procedural success), while angiographic success was achieved in 100% of cases at the target vessel, lesion level, and after stent implantation.

A low target lesion failure rate of 1.7% was observed, and no definite or probable stent thrombosis occurred during the 6-month follow-up period.

Acute lumen gain after final stent implantation was 1.60 ± 0.48 mm. Residual diameter stenosis was 12.5% ± 4.5. Median procedure duration was 59.5 minutes (40.5; 76.0).

OCT analysis confirmed the efficacy of the novel mechanism of action (N = 32; L = 32).

Calcium fractures and fragmentation were observed in more than 90% of calcified lesions, with multiple fractures present in 75% of lesions.

Fracture depth was 0.81 ± 0.33 mm, and fracture width was 0.66 ± 0.29 mm.

Deep calcium fractures following HC-IVL were also observed in both eccentric and concentric calcified lesions, supporting the proposed mechanism of action.

The maximum continuous calcium arc was 263.4° ± 77.1. Calcified nodules were present in 31% of cases.

Stent expansion was optimal, measuring 100.9 ± 24.3% at the minimal lumen area (MLA), 103.4 ± 25.6% at the maximum calcification site (MCS), and 96.7 ± 25.5% at the minimal stent area (MSA).

Optimal stent expansion (mean >90%) was achieved in both eccentric and concentric lesions, including those with calcified nodules.

OCT imaging confirmed high fracture depth and width even in complex calcified lesions

Coronary calcium score 4

Coronary calcium score 2, Calcified nodule

LithiX™ HC-IVL provides a safe and effective approach for calcium fragmentation to optimize stent implantation. No external energy source is required, and the procedure is characterized by a simplified workflow and a short learning curve.

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Safe intravascular lithotripsy in complex and high-risk PCI populations: My-IVL Study 2

The MY-IVL Clinical Study

The MY-IVL clinical study was an investigator-initiated, post-market study designed to evaluate the safety and performance of Hertz Contact intravascular lithotripsy (HC-IVL) for the treatment of calcified, stenotic coronary lesions prior to percutaneous coronary intervention (PCI) in real-world clinical practice. This all-comers study included a complex patient population with a wide range of calcified morphologies.

Study Design

A total of 102 consecutive patients were treated with HC-IVL.
Enrollment took place at Cardiac Vascular Sentral Kuala Lumpur (CVSKL) Hospital between April and September 2025.
All patients underwent angiography, and 100% received intravascular imaging (IVUS/OCT).
All imaging data were analyzed by an independent core laboratory (MedStar Health).

Endpoints

Primary safety endpoint: Freedom from MACE* within 30 days after the index procedure.

Co-primary efficacy endpoint 1: Proportion of patients achieving residual stenosis <30%, including both stent and drug-coated balloon (DCB) treatment, without intraprocedural MACE.

Weighted co-primary efficacy endpoint 2: Minimal stent area (MSA) compared with a ≥4.9 mm² performance goal (PG**), assessed by intravascular imaging (stent cohort only).

Follow-up was performed at 30 days.

MACE is defined as a composite of cardiovascular death, myocardial infarction, and target vessel revascularization.
The performance goal (PG) was derived from the mean MSA (5.65 mm²) reported in previous IVL and rotational atherectomy studies, with a statistical safety margin of 0.75 mm².

Baseline clinical presentation

§ Unstable angina, STEMI, or NSTEMI.
‡ Stable angina or silent ischemia.

Key lesion characteristics:

Key Results:

The results of the MY-IVL study demonstrated effective and safe fragmentation of a wide range of severely calcified lesion morphologies in a complex all-comers patient population.

Mean stent expansion after PCI:

Calcium Eccentricity	Eccentric Calcium		Concentric Calcium	Overall
Mean stent expansion‡, %	123.15 ± 13.81 (L=13)	106.77 ± 18.30 (L=13)	110.96 ± 17.97 (L=27)
Maximum continuous calcium arc, °	≤180°	>180° and ≤270°	>270° and ≤360°	113.71 ± 17.80 (L=58)

Of the 58 lesions with mean stent expansion, 53 had baseline calcium arc available.

Imaging Core Lab adjudicated.

Angiographische Ergebnisse

Final Post-PCI	L=116
Acute gain, mm	1.75 ± 0.58
Minimum lumen diameter, mm	2.65 ± 0.56
In-lesion DS, %	10.71 ± 11.49
In-lesion DS <50%	116 (100.0%)
In-lesion DS <30%	109 (94.0%)

Imaging Core Lab adjudicated.

Procedural safety endpoints:
No angiographic complications related to the IVL device*

Freedom from MACE (30 days): 98 (96,1 %)**

* Bei einem Patienten trat eine Perforation während der Stentimplantation auf (nicht im Zusammenhang mit HC-IVL).
** Es wurden keine gerätebedingten Ereignisse berichtet. Drei kardiovaskuläre Todesfälle wurden vom Prüfzentrum als nicht mit dem HC-IVL-Verfahren in Zusammenhang stehend bewertet; bei einem Todesfall war die Ursache unbekannt.

Co-primary efficacy endpoint – 1:
Proportion of patients with residual stenosis <30% and no intraprocedural MACE

96,3 %

((patients treated with a drug-eluting stent after HC-IVL)

Achieved co-primary efficacy endpoint – 2:
Minimal stent area‡ (MSA) of the stented lesion after HC-IVL (statistically evaluated)

Performance Goal † :

Mean MSA:

0 mm²

p < 0

0 mm²

(95% CI: 6.50–7.28)

View study results

¹Honton B, et al. ICARE trial, EuroPCR 2025²Abdelhakim A, et al. CCI. 2022 Nov;100(6):979-989³Ziad A, et al. Circ Interv. 2023, 16(10): e012898

Resources & Downloads

Product Information and Instructions for Use

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LithiX™

Product Flyer

Product Catalogue

Technical Product Documentation

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Instructions for Use

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1 Paradies V. TCT 381: Safety and Effectiveness of a Novel Intravascular Lithotripsy Device Using the Hertz Contact Stress Mechanism for Calcium Fragmentation: PINNACLE I Clinical Trial Six-Month Outcomes. Präsentiert auf der TCT 2024 im Namen der PINNACLE I-Investigatoren.

2 Muthusamy TS et al. Hertz contact intravascular lithotripsy for calcified coronary lesions in real-world practice: Primary outcomes of the MY-IVL post-market study. Cardiovasc Revasc Med. 2026. doi: 10.1016/S1553-8389(26)00101-6

3 LithiX HC-IVL Post-market Case Survey. Data on file.

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