Revolutionary Breakthrough: Elixir Medical Launches LithiX Hertz Contact IVL System, Redefining Treatment of Calcified Lesions

1. Major Release in Europe: With CE Certification, Clinical Application Officially Launches

On April 10, 2025, the medical technology field welcomed an exciting piece of news: Elixir Medical proudly announced the successful development of itsLithiX Hertz Contact (HC) Intravascular Lithotripsy System (IVL) Successfully Obtains EU Medical Device Regulation (MDR) CE Mark Certification and Immediately Embarks on Full Commercial Launch in the European Market.This milestone breakthrough not only signifies that the product has met the stringent standards of the EU in terms of technology and safety, but also heralds a new hope for cardiovascular disease patients across Europe and even globally.

It is worth mentioning that,LithiX Hertz Contact IVL System Quickly Applied in Clinical Practice After Certification, First Clinical Cases Successfully Completed.This clinical procedure was personally performed by three authoritative experts renowned in the field of cardiovascular intervention: Stefano Galli from Centro Cardiologico Monzino in Milan, Italy; Eric Van Belle from Lille University Hospital in France; and Nikos Werner from Barmherzigen Bruder Trier Hospital in Trier, Germany. Relying on their extensive clinical experience and exceptional professional skills, these three experts provided solid technical support for the first clinical application of the LithiX Hertz Contact IVL system, filling the medical community with high expectations for its clinical outcomes.

2. Technological Innovation: Hertz Contact Stress Principle, Precise Treatment Without Energy Dependence

The key reason why LithiX HC-IVL stands out among many intravascular lithotripsy systems lies in its breakthrough technical principle ——Exquisite Design Based on Hertz Contact Stress Principle. This innovative design is like opening a brand-new door for the field of cardiovascular interventional treatment, leading the industry towards a more efficient and safer direction with great strides.

The core component of the system isMultiple low-profile metal hemispheres integrated on the surface of a semi-compliant balloonThese seemingly ordinary metal hemispheres actually conceal a hidden mystery.When the balloon is applied to the calcified plaque at a low inflation pressure, the metal hemispheres quickly form highly localized contact points with the calcified plaque. At this moment, the magical effect of mechanics begins to manifest, as the concentrated mechanical force is precisely released, acting like precise "scalpels" that delicately "carve" the calcified plaque, promoting deep and wide fractures in the calcium.This fracture pattern is not a random disruption but rather a carefully considered approach that ensures treatment efficacy while maximizing the preservation of vascular structural integrity.

Compared with traditional energy-dependent IVL technology, the non-energy-driven feature of LithiX HC-IVL is undoubtedly one of its highlights.Traditional techniques, in relying on external energy sources, often struggle to avoid the risk of thermal damage to blood vessel walls caused by energy conduction—essentially planting a "time bomb" within the fragile vascular environment that could trigger a series of severe complications at any moment. In contrast, LithiX HC-IVL ingeniously avoids this risk as it operates without the need for external energy. Relying solely on its unique mechanical structure and principles of mechanics, it achieves highly efficient calcium modification, offering a more reliable safeguard for patients' vascular health.

In practical clinical applications,Precise control is an important indicator for measuring treatment effectiveness. LithiX HC-IVL achieves targeted effects on calcified lesions through the precise adjustment of balloon pressure.Like an experienced archer who can precisely hit the target, doctors can flexibly adjust the balloon pressure based on the specific condition and lesion characteristics of the patient, ensuring that the treatment process is both efficient and safe. This precise and controllable treatment method not only increases the success rate of the surgery but also significantly reduces unnecessary damage to the patient's body.

Moreover, LithiX HC-IVL has demonstrated exceptional capabilities in addressing complex lesion morphologies.Whether it is complex lesions such as concentric, eccentric, or nodular calcification, it can treat them with ease.This multifunctional adaptability empowers doctors with a more powerful treatment tool when facing various challenging cardiovascular diseases, bringing more hope of recovery to patients.

3. Clinical Validation: Highly Recognized by Experts, Research Data Supporting Efficacy

(1) Clinical Expert Evaluation

The clinical application effects of the LithiX Hertz Contact IVL system have received high praise from authoritative experts.Professor Stefano Galli excitedly stated after completing the first batch of cases"Optimal calcium modification is crucial for achieving good PCI outcomes, and LithiX Hertz Contact IVL, as an easy-to-use, versatile option with excellent clinical performance, achieves this goal." In his view, the system provides a safer and more efficient solution for calcification management in PCI procedures, with its operational simplicity and clinical effectiveness being highly impressive.

Professor Nikos Werner also spoke highly of the performance of LithiX HC-IVL, noting: "We are delighted to incorporate LithiX into our daily practice as a highly deliverable tool designed to safely modify calcified lesions. It is easy to use, with a high degree of precision and controllability." During the treatment of complex calcified lesions, LithiX HC-IVL demonstrated excellent controllability and stability, significantly optimizing the surgical workflow and allowing physicians to address various challenges with greater confidence.

Professor Eric Van Belle added, "In our first case, we have already seen the recent results of the PINNACLE study on the treatment of calcified coronary artery lesions with LithiX HC-IVL confirmed, achieving excellent procedural outcomes in both eccentric and concentric calcium." This means that the results of the first cases are highly consistent with the PINNACLE I study data, further validating the long-term effectiveness of LithiX in the treatment of calcified lesions and providing strong clinical evidence for the widespread application of this system.

(II) PINNACLE I Study Results

In addition to the validation by experts' clinical experience, the outstanding performance of the LithiX Hertz Contact IVL system has been fully demonstrated in rigorous scientific research. The six-month data from the company's recently published PINNACLE I study has created a strong impact in the medical community, like a blockbuster.

In terms of stent expansion rate, LithiX HC-IVL has demonstrated astonishing capabilities. For eccentric calcified lesions, the stent expansion rate is as high as 101.38%, meaning that the blood vessel can achieve nearly perfect expansion under the treatment of this system, providing a spacious passage for smooth blood flow; the stent expansion rate for concentric calcified lesions also reached 93.95%, which is equally satisfactory; and in nodular calcified lesions, the stent expansion rate is even higher at 102.81%, fully demonstrating the system's strong ability to handle various complex calcified lesions.

Through in-depth analysis using optical coherence tomography (OCT) imaging technology, researchers were pleasantly surprised to discover that LithiX HC-IVL excels in controlling vascular injury. During the treatment process, the integrity of the vessel wall in non-calcified areas was significantly preserved, with minimal damage compared to traditional techniques. This advantage not only reduces risks during the procedure but also creates favorable conditions for post-operative recovery, greatly decreasing the likelihood of complications.

In terms of long-term safety, LithiX HC-IVL has also delivered satisfactory results. The incidence of postoperative complications is lower than that of similar products, providing a solid guarantee for patients' health. More notably, after long-term follow-up observations, the system shows no risk of late thrombosis post-surgery. This important finding undoubtedly provides a strong boost to patients' long-term health, offering greater peace of mind to both patients and doctors.

IV. Industry Impact: Ushering in a New Era of Calcification Treatment

The unveiling of the LithiX Hertz Contact IVL system is like a brilliant new star, sparking a monumental transformation in the field of cardiovascular interventional therapy, with a profound impact that is enough to reshape the industry's development trajectory.

Elixir Medical CEO Motasim Sirhan confidently stated, "The launch of LithiX HC-IVL marks the entry of intravascular lithotripsy into the 'era of mechanical precision.' Its energy-independent feature not only lowers the clinical operation threshold but also overcomes the limitations of traditional technologies in complex lesions through innovative design." This statement accurately summarizes the core advantages of LithiX HC-IVL and highlights its revolutionary significance in the industry.

With the acceleration of the global aging population and changes in lifestyle, the incidence of coronary heart disease has shown a continuously rising trend, becoming the number one killer threatening human health. According to statistics from the World Health Organization (WHO), more than 17 million people die from cardiovascular diseases worldwide each year, with coronary heart disease accounting for a significant proportion. In light of this severe situation, the demand for treating calcified lesions has become increasingly urgent, posing a critical challenge that the medical community needs to address.

The emergence of LithiX HC-IVL undoubtedly provides a perfect solution to this challenging problem. With its unique Hertzian contact stress principle, the system has demonstrated unparalleled advantages in treating calcified lesions. Compared with traditional treatment technologies, it not only breaks up calcified plaques more effectively, achieving full vascular expansion, but also minimizes damage to the vessel wall, reduces surgical risks, and improves patients' postoperative quality of life.

From the perspective of clinical practice, the application prospect of LithiX HC-IVL is extremely broad. In the field of percutaneous coronary intervention (PCI), it is expected to become the preferred solution for treating calcified lesions. Its precise therapeutic effect and good safety can provide patients with more reliable treatment assurance, reduce the incidence of postoperative complications, and shorten the rehabilitation cycle. For doctors, the ease of operation and high controllability of LithiX HC-IVL also greatly reduce surgical stress, improving the success rate and efficiency of the surgery.

In addition to its application in the PCI field, LithiX HC-IVL also has the potential to expand into the treatment of other vascular diseases. Whether it is peripheral vascular disease or cerebrovascular disease, as long as it involves calcified lesions, LithiX HC-IVL may play an important role and bring hope to more patients.

From the initial launch in the European market to the future full-scale expansion into global markets, Elixir Medical is driving the innovative wave in the treatment of calcified lesions with LithiX HC-IVL as its core driver. Behind this groundbreaking achievement lies not only Elixir Medical's deep accumulation and relentless efforts in medical technology R&D over the years but also a solemn commitment to the quality of patients' lives. It makes us believe that, with the power of technology, every cardiovascular interventional procedure will become more precise, safe, and efficient, bringing a brighter future to cardiovascular disease patients worldwide.