# Interventional Cardiology

Endologix：Percutaneous Peripheral Covered Stent Bypass Graft System

Endologix's Percutaneous Peripheral Stent Graft Bypass System (DETOUR™)InJune 7, 2023Received FDA approval for marketing.DETOUR™PreviouslyReceived FDA Breakthrough Device Designation on September 2, 2020. The device is mainlyComposed of a peripheral covered stent and a vascular puncture system., a covered stent blood bypass is established in the vein accompanying the artery through a vascular puncture system, thereby alleviating symptoms caused by vascular stenosis and occlusion. (For details, see "Major Release! Innovative PAD Product Used for Surgery Treatment for the First Time》）

The DETOUR™ system is suitable for patients with femoropopliteal artery stenosis or occlusion who have target lesion lengths ranging from 200mm to 460mm, and present with chronic total occlusions (100mm to 425mm) or diffuse stenosis >70%, and exhibit clinical symptoms. These patients are typically difficult to treat through surgical or other endovascular methods. The DETOUR™ system or any of its components are not intended for use in coronary or cerebral vessels.In addition to winning awards in the field of interventional cardiology,DETOUR™ SystemStillSelected as the innovative device in the cardiac surgery field for the first Global Cardiovascular Award.。

Canon Medical: Evolve Technology

As the number of people suffering from cardiovascular diseases increases and cardiovascular diseases become more complex, the challenges faced by the interventional cardiology department are growing. Canon Medical Systems has launchedAlphenix / Evolve Edition Angiography Equipment to Assist Interventional CardiologyTheseChallenge.

Canon Medical's proprietary αEvolve technology,Leveraging artificial intelligence to provide innovative solutions for supporting high-quality, safe, and efficient diagnosis and treatment of cardiovascular diseases.Alphenix / Evolve Brings New Value to Interventional Cardiology.Alphenix / Evolve EditionIt was also selected as an innovative device in the field of cardiac imaging for the inaugural Global Cardiovascular Award.。

Concept Medical：Sirolimus-Coated Balloon

In May 2023, Concept Medical announced,Company's Product MagicTouch Sirolimus Coated Balloon (SCB) Receives FDA Investigational Device Exemption (IDE), marking the third IDE approval for the company's MagicTouch SCB series of products.The IDE approval covers devices used for treating small coronary arteries.The IDE approval will allow Concept Medical to initiate pivotal clinical studies to investigate the safety and efficacy of the device in small vessel coronary artery disease. (Details available at:《FDA IDE Approved! Sirolimus-Coated Balloon》）

MagicTouch SCB has been awarded the "Breakthrough Device" designation by the FDA.SuitableFor Percutaneous Transluminal Coronary Angioplasty, suitable for small coronary arteries with a vascular diameter of 1.50-2.75mm and lesions with a length of 6-36mm.In addition to the IDE approval for treating small vessels, Concept Medical has also received two additional IDE approvals for its MagicTouch SCB series products.Product for the treatment of in-stent restenosis in coronary arteries and below-the-knee indications。

Radiaction Medical：Automated Radiation Protection System

Radiaction, founded in 2014, is an innovative company dedicated to providing radiation protection for interventional physicians at risk of radiation exposure.RadiactionSelf-developed Radiation Shield System Automated Radiation Protection System,Is oneA Novel Radiation Protection System Installed on the C-arm. It combines sensor technology with highly automated robotic mechanics technology,Can be installed as an independent accessory on different existing C-arms in the market and is compatible with any professional program.. It has currently been proven to be compatible with Siemens Healthineers' Artis series fluoroscopic C-arm machines.

This Automated Radiation Protection SystemReceived FDA 510(k) approval in March 2022 and has a CE mark., isThe only fully automatic, integrated comprehensive protection device system。Automated Radiation Protection System isThe First Innovative Radiation Protection System to Block Radiation at the Source. This system enables full-body protection for medical staff without the need for them to wear protective gear, directly transforming the way radiation protection is provided for interventional medical personnel.TheAutomated Radiation Protection SystemAlso selected for the first-ever Global Cardiovascular Award in the field of patient safety.InnovatorInstrument。

Thubrikar：Optimum TAV

Optimum TAV is a product launched by Thubrikar Aortic Valve, Inc.Using nickel-titanium stents and bovine pericardium to prepare valve leaflet technologySelf-expanding TAVR.Optimum TAVThe shortest length among currently publicly available self-expanding TAVRs., its short profile facilitates coronary access, with a length similar to balloon-expandable TAVR products. The height of Optimum TAV is less than half that of commercially available self-expanding platforms, allowing for full coronary access. ItOptimal geometry and leaflet dynamics mimicking the natural aortic valve, with no suture holes in the flexure area。

According to Thubrikar,Optimum TAVThe biggest advantage is, adopting a design that mimics the normal aortic valve of the human body,Thereby creating an effective structure,Reduce stress configuration and extend durability.

In December 2023, Thubrikar announced that it had received authorization from Polish regulatory authorities to expand the TAVI-1 CE Mark trial for its Optimum Transcatheter Aortic Valve Implantation (TAVI) System.The authorization allows 15 additional patients to receive Optimum TAV treatment using the company's second-generation delivery catheter, Precision 2.

Precision 2 Catheter is meticulously designed to allow repositioning and recapturing of the Optimum TAV for retrieval during TAVI procedures. The short frame deployment of the Optimum TAV is enabled by the innovative catheter design.It will be reoriented in the diseased valve, thereby achieving automatic axial alignment of the valve.。

Dot Medical：iVAC 2L Short-Term Percutaneous Circulatory Cardiac Assist Device

The outer diameter of the iVAC 2L short-term percutaneous circulatory cardiac assist device is 17Fr, with a length of 100cm. It is inserted via the femoral artery, pneumatically driven, and can generate a circulatory assist flow of 2L/min. By actively reducing ventricular load, iVAC 2L provides hemodynamic support in HRPCI and CS treatment, with an assisting efficacy slightly higher than IABP (Intra-Aortic Balloon Pump (IABP)`, lower than ECMO`(Extracorporeal Membrane Oxygenation)Or Impella series products (artificial heart assist devices).

iVAC 2L is essentially a single-lumen catheter with an integrated rotating bidirectional valve at the tip, connected to an additional extracorporeal membrane pump.During operation, it is triggered by heart rhythm like IABP. When the heart is in systole, blood is drawn from the left ventricle into the membrane pump through the catheter tip and lumen; during diastole, the membrane pump discharges blood through the catheter, then opens the front valve of the catheter, and delivers the blood to the ascending aorta via the side-flow outlet. The closure of the aortic valve and the opening of the catheter valve maintain synchronized pulsation to ensure that the function of the aortic valve is not impaired.

Elixir Medical：DynamX® Coronary Bioadaption System

DynamX® Coronary Bioadaption SystemIt is Elixir Medical forOvercoming the Limitations of Drug-Eluting Stents and Bioresorbable ScaffoldsAnd developed.

DynamX®It is a new type of coronary implant,Its design purpose is to unlock stents, unseal blood vessels, and provide necessary dynamic support after unsealing during percutaneous coronary intervention, in order to restore normal vascular movement and function.。In October 2023, Elixir Medical announced that it had submitted a regulatory approval application for the DynamX® Coronary Bioadaptor System to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for the treatment of coronary artery disease.

GE Healthcare: Prucka 3 │ Cardiolab

On February 2, 2024, GE Healthcare announced the launch of its latest innovative product in the field of electrophysiology, equipped with the CardioLab EP recording system.Prucka 3，To help clinicians diagnose and treat arrhythmias。

Prucka 3 with CardioLab EP Recording System builds on over 20 years of success in the field of electrophysiology, offering a powerful ecosystem of mapping technologies., which helps provide accurate, efficient, and advanced analysis for the diagnosis and treatment of arrhythmia.

The digital platform of this system maintains high signal fidelity while reducing ambient noise through new signal filtering capabilities and enhanced power line noise reduction software. This forward-looking platform also provides a pathway for emerging technologies in electrophysiology that rely on quality signals for rapid interpretation of clinical outcomes.

Edwards Lifesciences: EvoqueTranscatheter Tricuspid Valve Replacement System

EVOQUE is a self-expanding tricuspid valve launched by Edwards Lifesciences.Composed of a self-expanding nitinol stent, bovine pericardial leaflets, a fabric skirt, and a leaflet clamping device, it features a unique anchoring mechanism that ensures stable implantation using the valve annulus, leaflets, and chordae tendineae through nine ventricular anchors. In February 2024, Edwards Lifesciences announced that its tricuspid valve product, EVOQUE, received FDA approval for market release.This isThe first FDA-approved transcatheter tricuspid valve replacement product. (For details, see "Milestone! The World's First TTVR System Receives FDA Approval for Market Launch》）

The EVOQUE Transcatheter Tricuspid Valve Replacement System is designed to replace the patient's native tricuspid valve without the need for open-heart surgery.The valve is implanted using a minimally invasive delivery system, where the doctor threads a thin tube through a vein in the patient's leg to reach the heart and perform the valve replacement surgery.。The EVOQUE valve is available in three sizes (44 mm, 48 mm, and 52 mm), all implanted through a low-profile 28F transfemoral delivery system.

# Cardiac Surgery

Philips Showcased at the 2023 Transcatheter Cardiovascular Therapeutics Annual MeetingA New Type3D Intracardiac Echocardiography (ICE) CatheterVeriSight Pro。TheThe catheter can generate three-dimensional images of cardiac structures, including valves, from inside the patient's heart without the need for general anesthesia.This solution can give experienced clinicians more confidence and control during interventional procedures.

VeriSight Pro can be integrated with Philips' advanced cardiac ultrasound systems.EPIQ CVx and EPIQ CVxi are used together,Can provide excellent 2D and 3D real-time image guidance for various procedures in structural heart disease and electrophysiology. Additionally,In an observational study,VeriSight ProDemonstrated safety and surgical efficacy comparable to transesophageal echocardiography (TEE).The latter requires inserting the ultrasound probe into the patient's esophagus and requires general anesthesia.VeriSight ProAlso selected as an innovative device in the field of cardiac imaging for the first Global Cardiovascular Award.。

# Patient and Doctor Safety

Stereotaxis: Magnetic Navigation Surgical Robot

In 2003, Stereotaxis (NYSE:STXSW), the pioneer and global leader in minimally invasive endovascular interventional magnetic navigation surgical robotics, launched the world's first magnetic navigation electrophysiology robot, Niobe. Subsequently, an upgraded version was introduced.Genesis RMN System Obtained FDA Approval for Market Launch in 2020The core components of the electrophysiology robotic system developed by Stereotaxis have received regulatory approval in China, Japan, the European Union, Canada, and other countries and regions. (More information available at: 'First Batch! Magnetic Navigation Surgical Robot Completes Cardiac Ablation Surgery》）

Genesis RMN uses smaller magnets, rotating along its center of mass,Allows for precise response to physician control.In the navigation program, the Genesis RMN System is 70% to 80% faster than the Stereotaxis Niobe.。Genesis RMNThe entire system is significantly smaller, designed to enhance the patient's experience on the operating table, provide doctors and nurses with more access to the patient during surgery, and increase laboratory space to improve the working environment.

Egg Medical：ScatteringRadiation Protection System

EggNest isEgg Medical, Inc. launched

A Comprehensive Scattered Radiation Protection System

，

Can be fully integrated into the workflow of modern catheterization laboratories.

EggNest is built on aNovel Carbon Fiber PlatformAbove, with integrated radiation shielding, replaces the patient mattress on the X-ray table.It can protect the entire medical team., significantly reducing scatter radiation exposure for both medical staff and patients. Proven by testing and independent hospital research,EggNest can bring the catheterization lab'sScattered radiation reduced by more than 91%。

# Digital Cardiovascular Devices

DASI Simulations provides decision support products driven by AI-powered computational predictive models. Its AI-based fully automated measurements offer high accuracy, repeatability, and reproducibility while accelerating the workflow of cardiac teams to reach optimal decisions more quickly.

June 2023,DASI SimulationsThe company announced its use for pre-TAVR modeling in transcatheter aortic valve replacement (TAVR).AI Model Receives FDA ApprovalAccording to reports, this artificial intelligence model (Precision TAVI) isDASI SimulationsThe First Product to Receive FDA Approval。

The solution provided by DASI Simulation starts with a simple click,Upload the patient's CT angiogram to the company's secure cloud server.. Based on proprietary technology, the company's cloud-based artificial intelligence platformRun simulations across integrated scenarios for each patient, and the resultsPresented as interactive content to doctors and cardiac teams, guiding them to reach the best decisions. Finally, the company's high-quality biomedical engineers conduct quality checks and can consult with the cardiac team around the clock, providing personalized support.

Egnite: Cardiac Patient Management Platform

Egnite is a healthcare startup spun off from Edwards Lifesciences.Using Artificial Intelligence and Big Data to Improve the Treatment of Heart DiseaseThe company's digital platform, CardioCare, can identify patients diagnosed with heart valve disease who have not received treatment. The platform uses artificial intelligence and data management to manage the population of cardiovascular disease patients for appropriate follow-up treatment. Despite the challenges of launching healthcare services during the pandemic,The platform has been recognized by clinicians and hospitals.。

Elem Biotech: Virtual Heart

ELEM BiotechCloud SuperComputers have developed simulation and modelingModel ""Virtual Human".Virtual humans can demonstrate how diseased organs function and predict treatment outcomes., can support virtual patient trials, helping doctors develop innovative treatment methods.

A virtual heart utilizes the powerful computing and graphic display capabilities of computers. By assigning the computer heart model with the myocardial, hemodynamic, dynamic electrical conduction, and biochemical characteristics of a living heart, and integrating various physiological and pathological knowledge, it replicates the morphology, structure, and functions of a real heart.Realistically reproduce the true activity of a living heart, including electrical activity, cardiac contraction and beating, and the continuous pumping of blood, among other processes. In short,Virtual HeartIntegratedHuman HeartElectrical Activity, Mechanical Deformation, and Fluid DynamicsThese three principles of physics, and can simulate the human heartChambers and Vascular System, Displaying the Human HeartConditions under different health, disease, and treatment scenarios.

FibriCheck：Atrial FibrillationRemote MonitoringSoftware

In 2017, the Belgian digital health company Qompium emerged among a group of digital health companies, and with its business unit FibriCheck, it was named the best digital health company by the European Society of Cardiology. Founded in 2014, FibriCheck isThe world's first medically certified（CE Class IIA，FDA Approval) applications that can remotely detect irregular heart rhythms, including atrial fibrillation。

FibriCheck Measurements Are Conducted via Smartphone，Users only need to place their finger on the smartphone camera for 60 seconds.Thereafter, the application will provide real-time analysis and display the results in a visual report to support evidence-based (remote) consultations and subsequent medical decision-making.

Health Innovation East Collaborates with West Suffolk Hospital Foundation Trust to Launch New Atrial Fibrillation Remote Monitoring Pilot Using FibriCheck Smartphone AppFibriCheck can be installed on smartphones and smartwatches., using the smartphone's camera to monitor arrhythmiaIf monitoring indicates that a patient may have atrial fibrillation, the hospital foundation will promptly contact the patient and take further actions.