Lvdong Medical's World-First 3D Intracardiac Guidance System Enters Green Channel for Innovative Medical Device Approval

Innovations that drive the industry often emerge from obscurity, much like a butterfly flapping its wings in the Amazon, never imagining that it would trigger a hurricane in Texas two months later.

Bioelectricity is widely present in the human body, maintaining normal physiological functions. When electrical currents pass rhythmically through the atria and ventricles, the atrial and ventricular muscles contract sequentially, resulting in the heartbeat. The heartbeat has its own intrinsic rhythm and is not easily disturbed by extra-cardiac factors. Pacemaker activity of cardiomyocytes has also been discovered in the distal pulmonary veins, which act as parallel islands of atrial myocardium. Under normal conditions, these areas exhibit synchronized electrical activity; however, they may occasionally generate delayed afterpotentials and triggered activity. The conduction of such abnormal electrical activity to the atria may trigger atrial fibrillation.

Atrial fibrillation itself can lead to sudden cardiac death; it may also cause secondary thrombus formation, with clots circulating systemically through the bloodstream and potentially occluding cerebral vessels, resulting in stroke.

Therefore, a single episode of abnormal electrical activity in the distal pulmonary veins can trigger atrial fibrillation (AF) or even death in patients. Of course, the triggering mechanisms of AF are complex; not every episode of AF is caused by abnormal electrical activity in the pulmonary veins, just as not every hurricane is caused by a butterfly.

Treatment options for atrial fibrillation include pharmacological cardioversion and catheter ablation, with the latest guidelines strongly recommending catheter ablation as a first-line therapy., such as circumferential pulmonary vein ablation, which involves first performing transseptal puncture, followed by isolation and ablation of the primary substrates and maintenance mechanisms of atrial fibrillation. In 1895, Wilhelm Röntgen discovered X-rays, which were widely applied in the medical field, thereby facilitating the rapid development of interventional procedures. Traditional ablation procedures are performed under fluoroscopic guidance, where puncture and ablation are carried out by assessing the relative positions between devices and anatomical structures on two-dimensional images.

With advancements in 3D mapping technology and its broader clinical adoption, 3D cardiac electrophysiology procedures have gradually replaced 2D procedures, becoming the mainstream approach for electrophysiological interventions.Atrial fibrillation ablation can basically be performed in 3D mapping mode, but transseptal puncture still requires X-ray guidance. Therefore, transseptal puncture has become the last critical step requiring radiation during atrial fibrillation ablation procedures and represents the final bottleneck to achieving a completely radiation-free procedure.

2022Year7Month, the world's first no-needXThe “3D Positioning Intracardiac Guidance System,” a product that utilizes wire assistance and ultrasound guidance to precisely locate the optimal atrial septal puncture site—the fossa ovalis—has been admitted into the “Special Examination and Approval Procedure for Innovative Medical Devices,” also known as the green channel.

This product was developed by Lvdong Medical, with its technology originating from Professor Yu Ronghui, one of the company’s founders. Lvdong Medical holds several proprietary core technologies and possesses complete intellectual property rights. Professor Yu is a Chief Physician at the Heart Center of Beijing Anzhen Hospital, Capital Medical University, and serves as the Chairman of the Academic Committee of the China Green Electrophysiology Alliance. He is a top-tier operator who has ranked first in China for the annual volume of 3D radiofrequency ablation procedures for seven consecutive years, and he is a recipient of the “Second National Renowned Doctor: Excellent Demeanor” award by People’s Daily Online.

The founders of Lvdong Medical, Yu Ronghui and Ouyang Xingdong, have both personally witnessed the twenty-year evolution of electrophysiology procedures from two-dimensional to three-dimensional mapping.

Before founding Lvdong Medical, Ouyang Xingdong spent two decades deeply immersed in the field of cardiovascular intervention, accumulating extensive sales and management experience in interventional consumables and electrophysiology (EP) consumables. He was personally involved in the widespread promotion of 3D mapping systems and possesses profound industry insights into green electrophysiology. He understands thatGreen electrophysiology is an essential necessity for pregnant women, children, patients with arrhythmias who have a history of severe allergy to iodinated contrast media, and interventional cardiologists suffering from occupational diseases due to chronic radiation exposure.Nowadays, 3D mapping systems such as Carto and EnSite have become standard equipment for interventional electrophysiology procedures, with transseptal puncture remaining the final barrier to achieving completely fluoroscopy-free electrophysiology.

The interatrial septum is located between the left and right atria, with the fossa ovalis being its thinnest region; therefore, the fossa ovalis is the ideal site for transseptal puncture to access the left atrium., the location, size, and shape of the fossa ovalis vary from person to person.In conventional surgery, fossa ovalis puncture typically relies on X-ray guidance and the physician’s experience.The physician slides the tip of the instrument along the interatrial septum. Since the fossa ovalis is a concave structure, a distinct “loss of resistance” sensation is perceived when the tip reaches this area. This technique is highly dependent on the operator’s experience, and cardiac tamponade resulting from erroneous puncture is the most frequent and severe complication.

The fossa ovalis is characterized not only by its thinness but also by distinct electrophysiological properties compared to the surrounding tissue, a significant clinical finding reported by Professor Yu Ronghui. Professor Yu conducted three-dimensional electroanatomic mapping of the fossa ovalis in 276 patients undergoing their first radiofrequency ablation for atrial fibrillation, demonstrating that the morphology of the fossa ovalis can be reconstructed electrically and used as a landmark for localization.

“Having spent many years in the industry, I clearly recognized the market opportunities for Professor Yu’s technology. Meanwhile, Professor Yu had a strong desire to translate his scientific research achievements into practical applications. Thus, riding the wave of innovation in medical devices, we founded Lvdong Medical,” introduced Ouyang Xingdong. In June 2018, Lvdong Medical was established in the Wuhan Gaoke Medical Device Park, dedicated to the research, development, and production of innovative green cardiac intervention devices.

Lvdong Medical’s globally pioneering “3D Positioning Intracardiac Guidance System” leverages the mature technology of “3D mapping systems” and utilizes the principles of electrophysiological mapping. Compared with traditional transseptal puncture, Lvdong Medical’s product features two core technologies: first, an electrical localization method for the fossa ovalis; and second, 3D visualization of devices with real-time tracking of their movement trajectories, enabling precise identification of the optimal puncture site under scientific guidance.

Currently, the majority of cardiac electrophysiology procedures are three-dimensional (3D) interventions, which involve modeling via 3D mapping systems and performing surgeries under the guidance of these 3D models. The foundation of electrophysiology procedures lies in the heart's electrical activity. Both domestically produced and imported 3D mapping systems feature electrical localization capabilities. The Lvdong Medical 3D Intracardiac Guidance System employs electrical localization technology, is compatible with all 3D mapping systems available on the market, and enables precise visualization and positioning within these systems.

Product Image of 3D Positioning Intracardiac Guidance System — Provided by the Company

Atrial septal puncture is a mandatory skill for interventional cardiologists and a critical step in atrial fibrillation ablation; however, it poses significant challenges in practical training. Lvdong Medical’s pioneering “3D-Positioned Intracardiac Guidance System” transforms atrial septal puncture into fossa ovalis puncture with real-time, precise positioning, thereby reducing the learning curve for physicians.

Given that the product is a global first-of-its-kind innovation with significant clinical value, the Lvdong team decided to apply for the Special Approval Procedure for Innovative Medical Devices (commonly known as the “Green Channel”) after finalizing mass production specifications and passing all required inspections. “In fact, many medical device companies aspire to secure Green Channel status, but the requirements are stringent. After careful benchmarking, we believe our product possesses the necessary capabilities to qualify.”

Special Approval Procedure for Innovative Medical Devices refers to the review and approval process implemented for medical devices that meet specific criteria. Under the premise of ensuring the safety and effectiveness of marketed products, this procedure applies to devices that hold invention patents for core technologies, are first-of-their-kind in China, lead internationally in technology, and demonstrate significant clinical application value.

Therefore, for medical device companies, the Green Channel represents not only tangible benefits, such as accelerated registration processes and fee reductions, but also official recognition of a product’s innovativeness and clinical value. In July 2022, Lvdong Medical’s 3D Positioning Intracardiac Guidance System was admitted to the Green Channel. The drug regulatory authorities and relevant technical institutions will conduct review and approval in accordance with the principles of early intervention, dedicated personnel oversight, and scientific evaluation, while ensuring that standards are not lowered and procedures are not reduced.

The “3D Positioning Intracardiac Guidance System” has currently entered the registration phase. According to Ouyang Xingdong, inclusion in the Green Channel has reduced the timeline by 6 to 9 months, and the product’s registration certificate is expected to be obtained in August 2023.

Regarding the post-market promotion of the product,Ouyang Xingdong stated that physicians with experience in 3D mapping and modeling would find it easy to adopt Lvdong Medical’s 3D positioning intracardiac guidance system, and that safer and more effective methods for transseptal puncture have long been pursued by electrophysiologists.Professor Yu Ronghui’s perspective, which uses the electrophysiological characteristics of the fossa ovalis potential as a basis for localizing the fossa ovalis, has sparked extensive discussion in both academic and clinical circles. His first-authored paper, “Three-Dimensional Transseptal Puncture Based on Fossa Ovalis Electrogram Characteristics: A Fluoroscopy- and Echocardiography-Free Approach,” published in JACC: Cardiovascular Interventions, is among the most highly cited green electrophysiology clinical research articles internationally in recent years.

In addition to atrial fibrillation ablation, Lvdong Medical’s 3D positioning intracardiac guidance system can be used for all procedures requiring left-heart access, such as left atrial appendage closure and valve interventions—a major hotspot in cardiovascular interventional therapy. Ouyang Xingdong stated that preliminary estimates suggest the population in China requiring left-heart system treatment via transseptal puncture to establish left-heart access reaches 40 million.

Currently, Lvdong Medical holds 21 patents, with two Class III prototype products and one Class II prototype product. Additionally, there are two Class III devices and one Class II device under development. In April last year, Lvdong Medical launched an innovative Class II product—the thoracentesis needle—which was the first product in Hubei Province approved under the Medical Device Registrant System. This launch also represents Lvdong’s proactive response to national policies encouraging innovation and accelerating commercialization.

In the future, Lvdong Medical will continue to delve deeper into the application of 3D mapping technology, promote the widespread adoption of 3D localization techniques in interventional procedures, deploy innovative green electrophysiology products, achieve radiation-free outcomes for more procedures, and pioneer green coronary interventions.

“Lvdong Medical’s vision is to pioneer and lead green cardiac interventions. Our mission is to develop and manufacture innovative cardiovascular interventional devices, address physicians’ pain points, serve healthcare professionals, and benefit patients,” said Ouyang Xingdong. “Numerous challenges will inevitably arise in realizing this vision, but entrepreneurship is precisely a continuous process of confronting and overcoming difficulties.”