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
May 16 2024 - 8:45AM
Business Wire
—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
—
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:
- 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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