Elixir Medical made an exciting announcement regarding the PINNACLE , which assessed the safety and efficacy of their LithiX™ Hertz Contact Intravascular Lithotripsy System (IVL) for treating moderate to severely calcified coronary artery lesions.

This study met its primary endpoint of clinical success, defined as optimal stent expansion without major adverse cardiovascular events (MACE) during hospitalization. The results were presented at EuroPCR 2024 in Paris.

The LithiX Hertz Contact IVL system was designed to tackle challenges in treating calcified lesions resistant to optimal stent expansion. Its mechanism of action, based on Hertz Contact Stress physics principles, does not require capital equipment, making the procedure workflow simpler.

The system utilizes small metal hemispheres on a flexible balloon to provide multiple contact points with the calcium, achieving calcium fragmentation while minimizing damage to non-calcified segments.

In the PINNACLE I trial, conducted across multiple centers in Belgium and the Netherlands, an impressive 98.3% of patients achieved clinical success, with 100% angiographic success across various calcification morphologies.

Additionally, all lesions achieved <50% and <30% residual diameter stenosis. The study demonstrated excellent safety, with only one peri-procedural non-Q-wave myocardial infarction, resulting in a 1.7% MACE rate through 30 days, and no procedural angiographic complications.

An optical coherence tomography (OCT) sub-study confirmed the severity of calcification and showed a high lesion fracture rate, contributing to optimal final stent expansion. The LithiX system demonstrated ease of use and integration into physician workflows, reducing procedure time and patient radiation exposure.

CEO of Elixir Medical, expressed excitement over the study's outcomes, highlighting the system's potential to improve percutaneous coronary intervention (PCI) treatment for patients with complex cardiovascular diseases. The development of Hertz Contact IVL presents a safe and effective treatment option for calcified lesions, addressing the growing need in PCI procedures.

The PINNACLE I trial is a prospective, multicenter study evaluating the LithiX Hertz Contact IVL System's safety, effectiveness, and performance for treating calcified lesions. Further data on primary safety and effectiveness will be reported through six months.

 

 

Source: businesswire.com

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