LithiX: The First Energy-Free IVL Balloon Receives CE Mark and Completes Initial Clinical Use in Europe

Apr 10, 2025 22:15 CST Updated 22:15

Elixir Medical

Medical Device R&D and Manufacturing Company

Elixir MedicalAnnouncing its IVL product ---LithiXReceived CE approval for marketing and completed the first batch of clinical applications in Europe.

Expert Evaluation

"Optimizing calcium modification is crucial for PCI prognosis. LithiX is easy to operate, has a wide range of indications, and demonstrates excellent clinical performance, making it an ideal choice for achieving this goal."

---Stefano Galli Centro Cardiologico Monzino

"LithiX is a highly controllable tool that safely modifies calcified lesions, bringing innovation to daily practice with its precision and maneuverability."

---Nikos Werner Hospital Barmherzigen Bruder Trier

"The first batch of cases validated the recent PINNACLE study results, with LithiX demonstrating excellent procedural outcomes in treating eccentric and concentric calcified lesions."
---Eric Van Belle Lille University Hospital

Executive Evaluation

"Lithotripsy, which has evolved from its application in urology decades ago to encompass both mechanical and energy-driven mechanisms today, must avoid potential damage to non-calcified vessels when using energy-based intravascular lithotripsy for effective calcium modification. LithiX, as the first mechanical IVL platform, achieves excellent outcomes across a wide range of calcified lesion morphologies while offering maximum vascular protection."

---Motasim Sirhan ECEO of Elixir Medical

Due to Johnson & Johnson's tremendous clinical and commercial success, an increasing number of devices have entered the IVL field. Boston Scientific has just recently completedBolt Medical officially enters the IVL field (peripheral IVL products have received FDA approval for market release), while Abbott and Philips have also initiated IVL clinical research. Other small companies such as FastWave Medical, Vantis Vascular, and AVS have successively introduced innovative IVL technologies.

The IVL products of the above-mentioned company share many similarities with Johnson & Johnson's IVL products. Both require the use of a main unit together with a shockwave balloon catheter.Johnson & Johnson's IVL is actually very similar.LithiXCompletely different from Johnson & Johnson's IVL, this is an impact balloon catheter that does not require a host machine (external energy source). Similar to using a traditional balloon catheter, it can achieve lithotripsy simply by inflating it. This can be said to completely颠覆传统的IVL球囊导管理解.

This disruptive IVL product offers many advantages over traditional IVL. Hospitals do not need to invest more money in purchasing equipment; they only need to buy consumables (which can save a lot of costs). Moreover,LithiXFully integrated into PCI procedures, making the surgery simpler and reducing operation time.The learning curve is smoother.

The true innovation lies in breaking conventions, not indulging in replication.

LithiX

LithiXIt is a passive IVL balloon catheter, which integrates multiple low-profile metal hemispheres evenly on the surface of a semi-compliant balloon. At low balloon inflation pressure, these hemispheres interact with calcium.The formation of highly localized contact points in the tissue. Through the mechanical amplification effect,LithiXCan create deep and extensive calcified cracks while minimizing damage to soft non-calcified vascular tissue.

Due toLithiXNo external energy source or host is required, thus significantly optimizing the PCI procedure compared to traditional IVL technology—shorter operation time and a more gradual learning curve.

LithiX Technology Principle

LithiXThe mechanism of lithotripsy is based onHertz Contact Stress Principle, without the need for external energy or large equipment, it achieves the expected performance of IVL through unique design while possessing the versatility to treat complex calcified lesions. It creates deep and wide fissures in calcified plaques through focal stress while minimizing damage to non-calcified vascular tissue.

LithiX Clinical Study

Announced at last year's TCT conferenceLithiX Six-Month Clinical Study:

98.3% Clinical Success Rate(Primary Efficacy and Safety Endpoints),100% Angiography Success RateCovering Various Types of Moderate to Severe Calcification Morphologies
100% LesionAchieve <30% residual diameter stenosis
Zero Intraoperative Angiography Complications, including no severe dissection, perforation, or acute occlusion after stenting
Superior Safety: Only one case of perioperative non-Q-wave myocardial infarction, with a 6-month target lesion failure rate1.7%

Subgroup Study of Intravascular Imaging
Subgroup analysis via optical coherence tomography (OCT) accurately evaluated the fragmentation effects of LithiX on different complex calcified morphologies:

Eccentric Lesion Group(Maximum continuous calcification arc 184.38±56.42 degrees, 33.3% with calcified nodules):

84.6% of lesions exhibited calcification rupture, 61.5% of lesions had ≥2 ruptures

Average Rupture Depth0.76±0.28 mm, average rupture width0.51±0.23 mm

Maximum Calcification Site Stent Expansion Rate97.86%, Minimum stent area site101.38%

Concentric Lesion Group(Maximum continuous calcification arc 317.47±22.51 degrees, 29.4% with calcified nodules):

94.7% of lesions exhibited calcification rupture, 84.2% of lesions had ≥2 breaks

Average Rupture Depth0.85±0.36 mm, Average Rupture Width0.75±0.29 mm

Maximum Calcification Site Stent Expansion Rate106.58%, Minimum stent area site93.95%

Elixir Medical

Elixir Medical Elixir Medical Corporation, located in California, USA, is a medical device company that develops next-generation platforms for the treatment of coronary and peripheral artery diseases, aiming to restore adaptive remodeling and pulsatile motion of blood vessels. Its mission is to transform the care of patients with heart and vascular diseases through innovation.