EuroPCR Spotlight: Two Breakthrough Technologies Target Cardiovascular 'Functional Restoration'

Jun 09, 2025 17:36 CST Updated 17:36

Elixir Medical

Medical Device R&D and Manufacturing Company

Cardiawave

Non-Invasive Ultrasound Therapy (NIUT) Medical Device Developer

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Heart Future

Recently, at the conference held in Paris2025 European Cardiovascular Intervention ConferenceAt EuroPCR 2025, two breakthrough technologies in the field of cardiovascular treatment stood out, namely:Elixir Medical CorporationThe DynamX Coronary Bioadaptor AndCardiawave CompanyofValvosoft Ultrasound System。

These two innovative products were respectively inCoronary ArteryAndHeart ValveThis treatment field has opened up new pathways, with its core concept being the restoration of the natural function of organs, rather than merely providing mechanical replacements for diseased structures.

# DynamX Coronary Bioadaptor

DynamX Coronary Bioadaptor(DynamX Coronary Bioadaptor System) is an innovative coronary interventional treatment device developed by Elixir Medical Corporation, designed to treat coronary artery disease (CAD).

The product consists of 3 units of 71.μmCobalt-chromium (CoCr) helical metal stentComposition, through lifeThingAbsorbable polymer coating (Novolimus) connection.

Unlike traditional drug-eluting stents (DES), DynamXIs the first kindDynamic Coronary Implantation Technology, itThrough itsUnique bioresorbable polymer coating and "unlock" mechanism, itsThe polymer coating is fully absorbed within six months after implantation, releasing an "unlocking" component that allows the helical stent to separate, enabling the vessel to regain pulsatility and undergo adaptive remodeling while maintaining dynamic support for the vessel.

Functional Advantages

Acute Performance: Similar to traditional DES, it can be used in the acute phase.Providing excellent initial vascular support and drug release, reducing the risk of restenosis.
Long-term Benefits: Through the "unlocking" mechanism,Restore the pulsatility, compliance, and blood flow adaptability of blood vessels, reducing long-term adverse events.
Biocompatibility：Spiral Collagen Fiber Structure Mimicking Vascular Wall, reduce mechanical constraints, and promote natural vascular healing.

The stent uses Novolimus, a sirolimus metabolite, as the drug coating.Low drug dosage (5μg/mm stent length), thin polymer coating (<3μm), no need for a primer layer, reducing the risk of inflammation。

Currently, this stentHas obtained EU CE certification and US FDA Breakthrough Device Designation, applicable for improving coronary artery lumen diameter, restoring hemodynamic regulation, and reducing plaque progression.

Test Data

BIOADAPTOR Randomized Controlled Trial (RCT)

Image Source: EuroPCR Official Website

This is a multicenter, single-blind, randomized controlled trial involving 445 patients (from 34 centers in Japan, Europe, and New Zealand), randomly assigned 1:1 toDynamX BioadaptorandResolute Onyx DES(Medtronic). The primary endpoint was1-Year Target Lesion Failure Rate (TLF)。

12-Month Results:

DynamX outperforms DES in imaging endpoints such as percentage of lumen diameter stenosis and late lumen narrowing.
Restoration of vascular pulsatility and compliance, with enhanced blood flow adaptability.

24-Month Results (EuroPCR 2024):

TLF Decreased by 65%（DynamX 1.9% vs. Resolute Onyx 5.5%，p=0.046）。
In the left anterior descending (LAD) artery,TLF Reduced by 78%（1.9% vs. 8.7%，p=0.028）。
No target vessel revascularization, myocardial infarction, or thrombotic events, demonstrating excellent safety.

INFINITY-SWEDEHEART Trial (TCT 2024)

In the complex percutaneous coronary intervention (PCI) population, 12-month data showed that DynamX performed well in patients with acute coronary syndrome.Significantly Reduced the Rate of Adverse Events。

European Mechanism Study (50 patients)

9-12-month late lumen loss (LLL) is only 0.08mm(Median: 0.02mm).
Intravascular ultrasound (IVUS) showed an increase in device area and vessel area, respectively.5% and 3%, the average lumen area remained stable.
Optical Coherence Tomography (OCT) showed the recovery of cyclic pulsatility, with approximately 11% variation in lumen area between systole and diastole.

# Valvosoft Non-invasive Ultrasound Therapy System

Valvosoft It is a non-invasive ultrasound treatment (NIUT) system developed by Cardiawave for the treatment ofSevere Symptomatic Aortic Stenosis (sSAS)。

The system throughHigh-Intensity Focused Ultrasound (HIFU) technology precisely performs micro-cracking on calcified tissue of aortic valve leaflets., thereby restoring the flexibility of the valve, enlarging the valve opening, and effectively alleviating heart failure symptoms caused by valve stenosis.

The entire treatment process does not require surgical opening of the chest or implantation of artificial valves, providing patients with a new, non-invasive treatment option. It has the following technical features:

Non-invasive treatment: Valvosoft UtilizationHigh-Intensity Focused Ultrasound, which can precisely target the calcified areas of the aortic valve,Softening Calcified Tissue Through Micro-Cracking, without causing damage to the surrounding soft tissues. This treatment method achieves its effects throughExternal Ultrasound ProbeCompleted, avoiding the invasive risks associated with traditional transcatheter aortic valve replacement (TAVR).
Therapeutic Mechanism: The working principle of the system isUtilizing the mechanical action of ultrasound to soften calcified valve tissue, thereby improving hemodynamics. The entire treatment process usually requires only one session to complete, without the need for long-term implantation of any device, thus reducing the need for postoperative anticoagulation therapy.
Safety: In the ongoing clinical trials, no risk of cerebrovascular abnormalities was found through MRI examinations, further demonstrating the safety of Valvosoft treatment.

Test Data

Valvosoft CompletedTwo First-in-Human Trials(FIM I and FIM II), the ongoing pivotal European study covers countries such as France, Germany, and the Netherlands, aiming to evaluate the system's safety, feasibility, and effectiveness in order to obtain CE certification.

Valvosoft's clinical trials include two first-in-human trials (Involving a total of40 patients, conducted respectively in France, the Netherlands, and Serbia) as well as the ongoing multicenter pivotal study, with the primary objective of comprehensively evaluating the safety, feasibility, and efficacy of Valvosoft in treating severe symptomatic aortic valve stenosis.

▲FigureTabletSource:EuroPCR official website

12-Month Results (May 2025)：

The feasibility of the treatment has been highly recognized.Successfully softened the calcified tissue of the aortic valve。
The aortic valve orifice area was significantly increased, while the mean transvalvular pressure gradient was reduced., which indicates that the patient's blood flow condition has significantly improved.
Excellent performance in terms of safety, no cerebrovascular abnormalities were found.
The patient's heart failure symptoms (such as shortness of breath, etc.) were significantly relieved, and the quality of life (KCCQ score) was significantly improved during the follow-up.85% of patients had improvement or stabilization in their New York Heart Association (NYHA) functional class.。
Throughout the treatment process, no serious adverse events were reported, such as stroke or valve damage, etc. (Within 30 days after treatment, 91% of patients had no major adverse cardiac events.）。

Principal Investigator of the study and Director of Cardiology at Rouen University Hospital, FranceHélène Eltchaninoff The results confirmed the technology's ability to improve hemodynamics and quality of life in a non-invasive manner, potentially becoming a long-term treatment option for aortic stenosis and possibly paving the way for other indications, such as pre-TAVI preparation.

Currently, ValvosoftStill in the clinical trial stage, not yet obtained CE or FDA certification, limited to research purposes only. The company is advancing pivotal studies in Europe, with expected CE certification in 2026-2027, and plans to enter the U.S. market.

# Company Introduction

Elixir Medical Corporation

Elixir Medical Corporation Founded in 2005, with its headquarters located in Milpitas, California, USA. With the goal of "Transforming Vascular Medicine," the company is committed to transforming the treatment of cardiovascular diseases through innovative technologies and improving patients' quality of life.

Elixir Medical focuses on the treatment of coronary artery and peripheral artery diseases, and its technical fields coverDrug-Eluting Stent (DES), Fully Absorbable Drug-Eluting Stent (BRS), and Drug-Eluting Bioadaptor System。

The company's core technology lies in the development of innovative cardiovascular treatment platforms that integrate drugs and devices, with the representative product being the DynamX Coronary Bioadaptor.

DynamX's "bio-adaptive" design goes beyond traditional DES, reducing long-term vascular constraint, and its market potential is mainly concentrated in high-end medical institutions in Europe, America, and the Asia-Pacific region.

Elixir Medical's products have been launched in Hong Kong (Completed the first DynamX implantation in 2020), Malaysia, Europe and other places have been applied, and Hong Kong expert Vincent Tsang has completedOver 100 Cases of DynamX Implantation。

In addition to DynamX, other products from Elixir Medical includeDESolve Series, this is a fully bioresorbable scaffold (BRS), whichCE certification by the European Union in 2013, using Novolimus, with a stent thickness of 0.081mm, featuring high flexibility.

In addition, the company'sLithiX HC-IVL SystemIn 2025 in the Asia-Pacific regionFirst Clinical Use，Using intravascular lithotripsy (IVL) to treat calcified lesions without an external energy source.

Cardiawave

Cardiawave Founded in 2014, with its headquarters in Levallois-Perret, France, Cardiawave SA is a company jointly established through the collaboration between the Langevin Institute (a global leader in the field of ultrasound imaging and therapy) and Georges Pompidou European Hospital (HEGP, a leader in valvular disease and cardiac ultrasound imaging).

Cardiawave Focuses onNon-invasive High-Intensity Focused Ultrasound (HIFU) Treatment Technology, with the goal of softening the calcified tissue of the aortic valve and restoring the function of the valve.

The core product of Cardiawave isValvosoft Non-Invasive Ultrasound Therapy System, forTreatment of Severe Symptomatic Aortic Stenosis, providing an alternative for patients who cannot undergo surgery, thereby improving their quality of life.

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