Elixir Medical Releases LithiX HC-IVL System Data from PINNACLE I Trial

Elixir Medical, a developer of disruptive technologies used to treat cardiovascular disease, announced positive six-month data from the PINNACLE I study. The study evaluated the safety and performance of its LithiX Hertz Contact (HC) Intravascular Lithotripsy System (IVL) to treat moderate to severely calcified coronary artery lesions, demonstrating safety and efficacy. 

“We developed LithiX to improve the IVL treatment of calcified lesions with shorter procedure times and effectiveness across a broad range of calcified lesions, and we’re delighted with the PINNACLE I study outcomes demonstrating its sustained safety and effectiveness,” said Motasim Sirhan, CEO of Elixir Medical. “Our team is committed to developing transformative cardiovascular technologies that deliver improved physician experiences and, most importantly, better clinical outcomes for patients.”

The data was presented at the annual scientific symposium of the Cardiovascular Research Foundation (CRF)— Transcatheter Cardiovascular Therapeutics (TCT). 

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 in a broad range of moderate to severe calcium morphologies by creating multiple discrete focal stress forces across hemisphere contact points.

The novel LithiX Hertz Contact IVL system is the first non-energy-based IVL technology designed to fragment moderate to severely calcified lesions resistant to optimal stent expansion.1 The LithiX IVL mechanism of action is based on the physics principle of Hertz Contact Stress. 

It propagates the required discrete forces to fragment calcium without causing vessel injury, with no need for energy source or capital equipment. The LithiX Hertz system also positively impacts PCI procedure workflow with short procedure times and a simpler learning curve.

The PINNACLE I study was a prospective, multicenter, single-arm clinical study evaluating the safety, effectiveness, and performance of the LithiX Hertz Contact Intravascular Lithotripsy (IVL) System to treat calcified lesions. 

The trial includes 60 patients across seven sites in Belgium and the Netherlands. An imaging subset of 32 patients underwent intravascular imaging assessment by OCT.

An intravascular imaging sub-study using optical coherence tomography (OCT) was conducted to assess lesion complexity and calcium fragmentation effectiveness of LithiX IVL across a range of complex calcium morphologies.

Key Results

• Excellent safety and efficacy with only one peri-procedural non-Q-wave myocardial infarction resulting in a 1.7% TLF event rate through 6 months.
• 98.3% clinical success (primary effectiveness and safety endpoint) with 100% angiographic success across a range of moderate to severe calcium morphologies.
• No procedural angiographic complications, including no severe dissections, perforation, or abrupt closure post-stenting.
• < 30% residual diameter stenosis was achieved in 100% of the lesions.
• 84.6% of eccentric lesions had documented fractures and 61.5% of lesions with 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) and 101.38% stent expansion at Minimum Stent Area (MSA) site.
• 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.

“The cardiology community has long sought solutions that can better treat patients with calcified lesions to achieve optimal PCI outcomes,” said Johan Bennett, M.D., study principal investigator and director of CTO/CHIP program at the University Hospital Leuven in Leuven, Belgium. “The six-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.”