Elixir’s LithiX HC-IVL System’s 6-Month PINNACLE I Data Presented

November 3, 2024—Elixir Medical recently announced 6-month data from the PINNACLE I study evaluating the safety and efficacy of the company’s LithiX Hertz Contact (HC) intravascular lithotripsy (IVL) system for the treatment of moderate to severely calcified coronary artery lesions.

According to the company, the LithiX HC IVL device is a nonenergy-based IVL technology designed to fragment moderate to severe calcified lesions resistant to optimal stent expansion. It is a transcatheter device comprising multiple discrete metal hemispheres incorporated on a semicompliant balloon. The system is designed to deliver calcium fragmentation in a broad range of moderate to severe calcium morphologies by creating multiple discrete focal stress forces across hemisphere contact points. The LithiX system is not approved for sale in the United States, advised the company.

PINNACLE I is a prospective, multicenter, single-arm clinical study that includes 60 patients across seven sites in Belgium and the Netherlands. An imaging subset of 32 patients underwent intravascular imaging assessment by optical coherence tomography (OCT).

The data were presented at TCT 2024, the 36th annual Transcatheter Cardiovascular Therapeutics annual scientific symposium of the Cardiovascular Research Foundation held October 27-30 in Washington, DC.

According to the company, the 6-month study data demonstrated the following:

• 98.3% clinical success for the primary effectiveness and safety endpoint with 100% angiographic success across a range of moderate to severe calcium morphologies.
• Treatment with the device achieved < 30% residual diameter stenosis in 100% of the lesions.
• There were no procedural angiographic complications, including no severe dissection, perforation, or abrupt closure post stenting.
• Safety and efficacy were excellent, the company noted, with one periprocedural non-Q-wave myocardial infarction resulting in a 1.7% target lesion failure event rate through 6 months.

Elixir Medical advised that the intravascular imaging substudy using OCT was conducted to accurately assess lesion complexity and calcium fragmentation effectiveness of LithiX IVL across a range of complex calcium morphologies.

In eccentric lesions with 184.38º (± 56.42) of maximum continuous calcium arc with calcium nodules present in 33.3% of lesions, the findings showed:

• 84.6% of eccentric lesions had documented fractures.
• 61.5% of lesions had two or more fractures with 0.76 mm (± 0.28 mm) average fracture depth and 0.51 mm (± 0.23 mm) average fracture width.
• 97.86% stent expansion at maximum calcium site (MCS).
• 101.38% stent expansion at minimum stent area (MSA) site

In concentric lesions with 317.4º (± 22.51) of maximum continuous calcium arc with calcium nodules present in 29.4% of lesions, the findings showed:

• 94.7% of lesions had documented fractures and 84.2% of lesions with two or more fractures with 0.85 mm (± 0.36 mm) average fracture depth and 0.75 mm (± 0.29 mm) average fracture width.
• 106.58% stent expansion at MCS and 93.95% stent expansion at MSA site.

Johan Bennett, MD, director of the CTO/CHIP program at the University Hospital Leuven in Leuven, Belgium, is the study’s principal investigator.

“The cardiology community has long sought solutions that can better treat patients with calcified lesions to achieve optimal PCI outcomes,” commented Dr. Bennett in the Elixir press release. “The 6-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.”

Earlier this year, Elixir Medical announced that the PINNACLE I clinical success outcomes, defined as optimal stent expansion after final treatment with no in-hospital major adverse cardiovascular events through 30 days, were presented at EuroPCR 2024, which was held May 14-17 in Paris, France.