The PINNACLE I study demonstrated that Hertz Contact intravascular lithotripsy (HC-IVL) effectively modifies calcified coronary lesions, enabling consistent plaque fracture and improved vessel expansion during PCI. Imaging results confirmed treatment effectiveness across a range of calcium morphologies.
Unlike traditional lithotripsy systems that require an external generator, HC-IVL is designed to operate without a console, simplifying procedural workflow and enabling greater flexibility in the cath lab.
target lesion failure out to 6 months
met primary safety and effectiveness endpoint of clinical success
lesions achieved <30% residual diameter steonsis
| Type of calcified lesion | Final stent expansion at minimum stent area | Fracture depth* | Fracture width* |
|---|---|---|---|
| Eccentric | 101.38% | 0.76 mm | 0.51 mm |
| Concentric | 93.95% | 0.85 mm | 0.75 mm |
| Nodules | 91.40% | 0.81 mm | 0.57 mm |
LithiX™ HC-IVL offers a safe, effective approach for calcium fragmentation to optimize stent implantation, without a need for external energy source and a simplified IVL workflow and learning curve
PINNACLE I outcomes demonstrated the effectiveness and safety of LithiX Hertz Contact IVL for calcium fragmentation in a broad complex range of calcium morphologies
OCT analysis demonstrated effectiveness of the novel mechanism of action (N = 32; L = 32#)
In PINNACLE I, OCT Imaging confirmed high fracture depth and width, even in complex calcified lesions.
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The PINNACLE I study demonstrated that Hertz Contact intravascular lithotripsy (HC-IVL) effectively modifies calcified coronary lesions, with imaging confirming plaque fracture and improved vessel expansion during PCI.
Calcified coronary lesions introduce variability and resistance that can limit device delivery, prevent full balloon expansion, and ultimately compromise stent deployment. When calcium is not adequately modified, it can lead to under-expanded stents, malapposition, and poorer long-term outcomes.
Effective lesion preparation is critical to achieving optimal PCI results.
Calcium fragmentation creates fractures within the calcified plaque in a coronary artery, allowing the vessel to expand more naturally during balloon dilation and stent deployment.
When fractures are:
They enable:
In the PINNACLE I study, calcium fracture and fragmentation were identified in over 90% of lesions. This data supports the role of controlled fracture using LithiX Hertz Contact intravascular lithotripsy in PCI for eccentric, concentric, and nodular calcium morphologies.
Traditional IVL systems rely on external generators to produce acoustic pressure waves that fracture calcium. While effective, these systems introduce additional equipment and workflow considerations in the cath lab.
Newer approaches, such as Hertz Contact IVL, are evolving IVL by:
These approaches represent a shift from energy-based systems to mechanically driven precision calcium modification.
Yes, but not all technologies perform equally across all morphologies. Calcified lesions can present as:
In the PINNACLE I study, LithiX demonstrated effective calcium fracture across a broad range of these morphologies, with imaging confirming deep and consistent fractures even in complex lesions.
Stent expansion is directly dependent on how well the underlying calcium is modified. If calcium remains rigid:
When calcium is effectively fractured:
PINNACLE I data demonstrated high levels of stent expansion across multiple measurement points, reinforcing this relationship.
Hertz Contact intravascular lithotripsy is designed to operate without an external power source or console, simplifying workflow and enabling greater flexibility in the catheterization lab compared to traditional systems.
The system utilizes mechanical force from small metal hemispheres delivered on a catheter similar to a ballon. The force causes fractures in the calcium without damaging the vessel soft tissue.
PMN 2503 Rev A
PMN 1777 Rev A
