Elixir Medical, a developer of disruptive technologies to treat cardiovascular disease, today announced positive six-month data from the PINNACLE I study evaluating the safety and performance of its LithiX™ Hertz Contact (HC) Intravascular Lithotripsy System (IVL) for the treatment of moderate to severely calcified coronary artery lesions demonstrating safety and efficacy. The data were presented at Transcatheter Cardiovascular Therapeutics® (TCT®), the annual scientific symposium of the Cardiovascular Research Foundation® (CRF®).
“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.”
LithiX data results demonstrate:
- 98.3% clinical success (primary effectiveness and safety endpoint) with 100% angiographic success across a range of moderate to severe calcium morphologies
- < 30% residual diameter stenosis was achieved in 100% of the lesions
- No procedural angiographic complications, including no severe dissections, perforation, or abrupt closure post-stenting
- 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
An intravascular imaging sub-study using optical coherence tomography (OCT) was conducted to accurately assess lesion complexity and calcium fragmentation effectiveness of LithiX IVL across a range of complex calcium morphologies.
OCT sub-study results demonstrate LithiX IVL treatment effect across a broad range of lesions:
- In eccentric lesions with 184.38 (± 56.42) degrees of maximum continuous calcium arc with calcium nodules present in 33.3% of 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
- In concentric lesions with 317.47 (± 22.51) degrees of maximum continuous calcium arc with calcium nodules present in 29.4% of lesions:
- 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
“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 novel LithiX Hertz Contact IVL system is the first non-energy based IVL technology designed to fragment moderate to severe calcified lesions resistant to optimal stent expansion.1 The LithiX IVL mechanism of action is based on the physics principle of Hertz Contact Stress propagating the required discrete forces to fragment calcium without causing vessel injury, without the need for energy source or capital equipment, and positively impacting PCI procedure workflow with short procedure times and simpler learning curve.
About the PINNACLE I Trial
PINNACLE I is a prospective, multicenter, single-arm clinical study evaluating the safety, effectiveness, and performance of the LithiX Hertz Contact Intravascular Lithotripsy (IVL) System for the treatment of 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.
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 in a broad range of moderate to severe calcium morphologies by creating multiple discrete focal stress forces across hemisphere contact points. Using this unique mechanism of action, the LithiX Hertz Contact IVL System aims to improve treatment of moderate to severe calcified lesions without requiring an external power source, positively impacting PCI procedure safety, effectiveness, and workflow.
The LithiX IVL System is not approved for sale in the U.S.
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.