[NEWS] First Post-Market Clinical Application of EF-cross® Transseptal Puncture System in Chinese Hospital

WUXI, China – On October 24, 2025, Dr. Wang Xiaoyan, Director of the Department of Cardiology at Jiangnan University Affiliated Hospital, led Dr. Su Heng’s team in successfully performing the first post-market clinical application of the EF-cross® Transseptal Puncture System in Jiangsu Province during a pulsed-field ablation procedure. The entire process, from delivering the EF-cross® system to completing the transseptal puncture, took approximately three minutes. Dr. Wang commented, “Traditional transseptal puncture methods require multiple steps and pre-shaping of the puncture needle. The EF-cross® system, paired with an adjustable sheath, streamlines the process into a single, seamless operation, eliminating unnecessary complications associated with sheath and guidewire exchanges.”

Significance of Transseptal Puncture

Transseptal puncture is a critical procedure in interventional cardiology, enabling access from the right atrium to the left atrium through the atrial septum to establish a pathway for left heart treatments. This technique is widely used in procedures such as catheter ablation, percutaneous left atrial appendage closure, congenital heart disease interventions, and other therapies requiring transseptal access.

Patient Profile

The patient, a 72-year-old female with a history of hypertension and coronary artery disease, presented with a one-week history of palpitations and occasional chest tightness. She reported no chest pain, dizziness, syncope, fever, cough, or nocturnal paroxysmal dyspnea. Her appetite, bowel movements, and weight remained stable. Preoperative diagnoses included:

1. Palpitations

2. Arrhythmia (paroxysmal atrial fibrillation)

3. Coronary artery disease

4. NYHA Class I heart function

5. Grade 3 hypertension

Procedure Details

The patient underwent pulsed-field ablation for paroxysmal atrial fibrillation. Her baseline heart rhythm was sinus rhythm with a heart rate of 65 beats per minute. The procedure involved:

• Puncturing the left femoral vein and inserting two 7F sheaths, through which a decapolar mapping electrode was placed in the coronary sinus and a quadripolar electrode in the right ventricle.

• Puncturing the right femoral vein, inserting a long guidewire, and advancing a Vizigo® adjustable sheath.

• Delivering the EF-cross® Transseptal Puncture System through the sheath, successfully puncturing the atrial septum, and advancing the adjustable sheath into the left atrium, followed by heparinization.

• Deploying a circular pulsed-field ablation catheter via the adjustable sheath to perform ablation in the left atrium.

Expert Feedback

Post-procedure, Dr. Wang praised the EF-cross® system, highlighting its “3A” performance: Accurate, Agile, and Assured. Compared to traditional devices, the EF-cross® integrates a puncture needle, guidewire, and adjustable sheath into a single system, enabling a true “one-step” transseptal puncture. This innovation significantly enhances procedural efficiency, reduces complications associated with guidewire and sheath exchanges, and eliminates the need for manual needle shaping, thereby improving safety and operational precision.

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About Dr. Wang Xiaoyan

Dr. Wang Xiaoyan, Director of Cardiology, Chest Pain Center, and Functional Department at Jiangnan University Affiliated Hospital, is a distinguished professor, master’s supervisor, and branch secretary. Her credentials include:

• Expert for National Basic Medical Insurance Drug Catalog Adjustment

• Jiangsu Provincial Medical Insurance Bureau Expert for Consumables and Drug Evaluation

• Training Expert for Jiangsu Heart Failure Branch of China Cardiovascular Health Alliance

• Member of the Wuxi Medical Accident Appraisal Expert Pool

• Member of Jiangsu Provincial Work Injury and Social Security Appraisal Expert Pool

• Jiangsu Special Drug Expert

• Editorial Board Member of United Journal of Cardiology and Cardiovascular Medicine

• Member of the Society for Cardiovascular Angiography and Interventions (SCAI), USA

• Member of various national and provincial cardiovascular and arrhythmia committees

• President of the Wuxi Physicians Association Cardiovascular Branch

• Chair of the Wuxi Medical Association Hypertension Branch

• Vice-Chair of the Wuxi Medical Association Cardiovascular Branch

The successful application of the EF-cross® system marks a significant advancement in transseptal puncture technology, offering a safer, more efficient solution for complex cardiac interventions. This milestone underscores Jiangnan University Affiliated Hospital’s commitment to pioneering innovative medical technologies for improved patient outcomes. In collaboration with REBIO, a leader in cross-border medical services, the hospital is dedicated to providing cutting-edge cardiovascular care to a global patient base. Through this partnership, REBIO facilitates access to advanced treatments like the EF-cross® procedure, connecting international patients with world-class medical expertise and innovative technologies at Jiangnan University Affiliated Hospital. For more information on accessing these services, visit REBIO’s cross-border medical platform.