EuroPCR 2024: Primary Outcomes from PINNACLE I Clinical Trial Establish Safety and Effectiveness of Elixir Medical’s Hertz Contact Intravascular Lithotripsy System for Calcium Fragmentation in Moderate to Severe Calcified Coronary Artery Lesions

• Primary safety and effectiveness endpoints were met with 98% clinical success rate and 100% angiographic success in achieving optimal stent expansion
• Unique IVL mechanism of action effective across broad range of moderate to severe calcified lesion morphologies with more than 90% of lesions demonstrating fractures

PARIS--(BUSINESS WIRE)-- Elixir Medical, a developer of transformative technologies to treat cardiovascular and peripheral disease, today announced that the PINNACLE I study evaluating the safety and performance of its LithiX™ Hertz Contact Intravascular Lithotripsy System (IVL) for treatment of moderate to severely calcified coronary artery lesions met its primary safety and effectiveness endpoint of clinical success. Clinical success was defined as optimal stent expansion after final treatment with no in-hospital major adverse cardiovascular event (MACE). The primary safety endpoint was MACE through 30 days. The data were presented at an innovation session at EuroPCR 2024 in Paris.

The novel LithiX Hertz Contact IVL system is designed to address challenges associated with the percutaneous treatment of nodular, concentric, and eccentric moderate to severe calcified lesions resistant to optimal stent expansion. The IVL mechanism of action is based on a physics principle of Hertz Contact Stress and requires no capital equipment making the procedure workflow and learning curve simpler and faster. The system incorporates plurality of small metal hemispheres on a flexible balloon designed to provide multiple discrete contact points with the calcium. Calcium fragmentation is achieved by discrete amplification of force through Hertz Contact Stress IVL to create a multitude of fractures through the calcium while having minimal effect on non-calcified segments of the lesion, minimizing vessel injury. The device was studied in the PINNACLE I clinical trial, a prospective, multi-center, single-arm trial including 60 patients across seven sites in Belgium and the Netherlands. OCT images of 32 patients were analyzed in the OCT sub-study. Angiographic and intravascular imaging results were adjudicated by an independent core lab.

Clinical Safety and Effectiveness Results:

• 98.3% clinical success (primary safety and effectiveness) with 100% angiographic success across a broad range of moderate to severe calcium morphologies including eccentric, concentric, and nodular calcifications
  • <50% and <30% residual diameter stenosis was achieved in 100% of the lesions
  • Excellent safety with only one peri-procedural non-Q-wave myocardial infarction resulting in a 1.7% MACE event rate through 30 days
  • No procedural angiographic complications, including no severe dissections, perforation, or abrupt closure post-procedure

A core lab adjudicated optical coherence tomography sub-study was conducted to accurately assess lesion complexity and calcium fragmentation effectiveness of the LithiX Hertz Contact IVL System.

OCT Sub-Study Results:

• Calcification severity confirmed with 263.4 degrees of maximum continuous calcium arc and 23.9 mm average calcium length. Calcium nodules were present in 31% of the lesions.
• Very high lesion fracture rate with significant depth and width of fractures:
  • >90% of lesions with documented fractures and 75% of lesions having two, three, or more fractures
  • 0.81(±33) mm average fracture depth and 0.66 (±29) mm average fracture width
• Optimal final stent expansion with high stent area by all measurement classifications
  • 103.4% stent expansion at Maximum Calcium Site
  • 96.7% stent expansion at Minimum Stent Area (MSA) site

“The PINNACLE I data are particularly exciting because they clearly demonstrate LithiX IVL’s ingenious and intuitive IVL mechanism of action, which is hard on calcium and atraumatic on the soft tissue,” said Stefen Verheye, M.D., Ph.D., interventional cardiologist at ZNA Cardiovascular Center in Antwerp, Belgium. “The multitude of clearly visible and deep fractures, which exceeded our expectations, contributed to the optimal and uniform final stent expansion. Ease of use and simple integration of the device into physician’s workflow also helps shorten the learning curve and procedure time, and reduces radiation exposure for the patient which is of significant value in these complex interventions.”

“We are thrilled with the outcome of the PINNACLE I study validating the safety and effectiveness of the LithiX HC IVL in fragmentation of a broad range of moderate to severe vessel calcifications that would elevate PCI treatment for patients with complex cardiovascular disease,” said Motasim Sirhan, CEO of Elixir Medical. “This builds on Elixir’s commitment to lead in cardiovascular disease treatment for years to come through Elixir’s differentiated portfolio of transformative cardiovascular disease treatment options including the DynamX bioadaptor, LithiX HC IVL, and TRx anti-thrombotic therapeutic.”

Today, nearly one-third of PCI patients present with a calcified coronary lesion and this number is expected to increase due to the aging population and increased presence of comorbidities.¹ Development of Hertz Contact intravascular lithotripsy as validated by PINNACLE I data offers an effective and safe treatment option for patients with short procedure time, simple learning curve, and utility in treatment of a broad range of moderate to severe calcified lesions.

About PINNACLE I Trial

The PINNACLE I is a prospective, multicenter, single-arm clinical study evaluating the safety, effectiveness, and performance of the LithiX Hertz Contact IVL Lithotripsy System for the treatment of calcified lesions. The trial includes 60 patients across five sites in Belgium and the Netherlands. An imaging subset of 30 patients underwent intravascular imaging assessment by OCT. Primary safety and effectiveness will continue to be reported through six months.

About LithiX Hertz Contact Intravascular Lithotripsy System

LithiX Hertz Contact IVL System is a transcatheter device comprising multiple discrete metal hemispheres incorporated on a semi-compliant balloon. The system is designed to deliver calcium fragmentation for a broad range of moderate to severe calcium morphologies by creating multiple discrete focal stress contact points. Using this unique mechanism of action, the LithiX Hertz Contact IVL System aims to enable treatment of moderate to severe calcified lesions without the need for capital equipment positively impacting PCI procedure workflow.

The LithiX IVL System is not approved for sale in the U.S.

About Elixir Medical

Elixir Medical Corporation, a privately-held company based in Milpitas, California, develops disruptive platforms to treat coronary and peripheral artery disease. Our transformative technologies have multiple applications across the cardiovascular space capable of delivering improved clinical outcomes for millions of patients. Visit us at www.elixirmedical.com and on LinkedIn and X.

Reference:

1. Cialdella P, Sergi SC, Zimbardo G, Donahue M, Talarico GP, Lombardi d’Aquino UM, Di Fusco P, Calò L. Calcified coronary lesions. Eur Heart J Suppl. 2023 Apr 26;25(Suppl C):C68-C73. doi: 10.1093/eurheartjsupp/suad009. PMID: 37125323; PMCID: PMC10132609.

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