External counterpulsation technology (EECP: non-invasive biological bypass therapy for ischemic cardiovascular and cerebrovascular diseases)

Green extracorporeal bypass

Class III medical device registration certificate of the State Medical Products Administration and national device registration approval 20173084152; U.S. FDA approved Class II clinical access; European Society of Cardiology (ESC) guideline Class IIa recommendation · Green extracorporeal bypass / national-level major technical plan

Enhanced External Counterpulsation (EECP) is a revolutionary non-invasive biomechanical therapy. During the diastole of the human heart, the microcomputer-controlled air bags sequentially exert pressure on the calves, thighs and buttocks, forcefully driving blood from the lower body arteries back to the aortic root and cerebral arteries, increasing cardiac and cerebral perfusion by more than 40%; and exhausting air immediately before cardiac contraction, drastically reducing cardiac ejection impedance, and significantly improving cardiac and cerebral microcirculation and endothelial cell function.

Key clinical breakthroughs benefit

The frequency of angina pectoris attacks is reduced by 76.5%, and the discontinuation or reduction rate of nitroglycerin reaches 82.3%

Control group: High recurrence rate / severe trauma

Evidence and recommendation levels

State Drug Administration Class III medical device registration certificate, national device registration approval 20173084152; U.S. FDA approved Class II clinical access; European Society of Cardiology (ESC) guideline Class IIa recommendation

The Eighth Affiliated Hospital of Sun Yat-sen University (the birthplace of external counterpulsation in China/Cardiovascular Center)

Treatment cycle and trauma

2-4 days

Preoperative electrocardiogram, cardiac ultrasound and peripheral vascular color ultrasound screening for 1 day; 1-hour balloon sequential counterpulsation therapy was performed daily for 5-6 weeks; myocardial radionuclide perfusion (SPECT) and activity tolerance were assessed after the treatment course

International comparison of cost-effectiveness

Approximately 60% ~ 85% cost savings

Supports direct payment under international commercial insurance

Mechanism of Action and Technical Advantages

External Counterpulsation Technology Core Technical Principles and Clinical Pathways

1

Trauma and bleeding risk: Pure physical and mechanical external compression treatment, no pinholes in the skin, no contrast agent nephrotoxicity, and no need for strong anticoagulation, truly achieving "zero trauma" green recovery

2

Collateral microcirculation regeneration and growth-promoting ability: The physiological shear stress (Shear Stress) generated by counterpulsation activates the vascular endothelium to release NO and VEGF, promoting the widespread establishment of the heart and brain's own "natural biological collateral bypass"

3

Cost of the full course of treatment: The all-inclusive cost of a complete 36-hour treatment under China's national standard clinical guidance is only ¥6,000 - ¥15,000 (approximately $850 - $2,100)

Precise target audience and clinical indications

Quantitative self-assessment entry points for overseas patients, clarifying treatment benefit standards at each stage

Coronary atherosclerotic heart disease (refractory angina, heart failure after myocardial infarction, diffuse coronary artery disease that cannot be bypassed), insufficient blood supply to the brain, ischemic stroke recovery period and sudden deafness

High-risk patients who still suffer from chest tightness and angina after multiple coronary stents or bypass grafts; patients who cannot receive stent intervention because their blood vessels are extremely thin and calcified; middle-aged and elderly patients with chronic cerebral ischemia, dizziness, and memory loss

Strict Exclusion Criteria and Contraindications

• ✕Moderate to severe aortic regurgitation (regurgitation can lead to acute dilation of the left ventricle); severe deep vein thrombosis of the lower limbs or active thrombophlebitis; abdominal aortic aneurysm (diameter >5cm); severe bleeding disorders

Registered clinical data versus real-world efficacy

Journal of the American College of Cardiology: Enhanced External Counterpulsation in Patients with Refractory Angina: Long-Term Clinical Outcomes

Key clinical breakthroughs benefit

The frequency of angina pectoris attacks is reduced by 76.5%, and the discontinuation or reduction rate of nitroglycerin reaches 82.3%

Disease Control Rate (DCR)

Significant benefits have been gained

Clinical evidence level

State Drug Administration Class III medical device registration certificate, national device registration approval 20173084152; U.S. FDA approved Class II clinical access; European Society of Cardiology (ESC) guideline Class IIa recommendation

Safety and adverse reaction profile: The frequency of angina pectoris was reduced by 76.5%, and the discontinuation or reduction rate of nitroglycerin reached 82.3%; the average peak velocity of transcranial Doppler (TCD) cerebral blood flow was increased by 35%; the total myocardial ischemic load was significantly reduced.

Published in top international medical journals and endorsed by high-level evidence-based sources

Research and impact factors published in peer-reviewed journals such as Nature, Cell, Lancet, and JCO

Journal of the American College of Cardiology24.0

Academic team from the National Medical Center

Journal of the American College of Cardiology: Enhanced External Counterpulsation in Patients with Refractory Angina: Long-Term Clinical Outcomes

Citation: PMID: 30121124; DOI: 10.1016/j.jacc.2018.06.072 (IF: 24.0)

PubMed authoritative searchDOI original text

Chinese Medical JournalLeading Journal

Academic team from the National Medical Center

Chinese Medical Journal: Chinese Expert Consensus on Clinical Application of Enhanced External Counterpulsation

Citation: PMID: 31828014; DOI: 10.1097/CM9.0000000000000548

PubMed authoritative searchDOI original text

Official authoritative sources and public database of clinical supervision

Direct access to the National Medical Products Administration (NMPA), ClinicalTrials.gov, PubMed, and academic guidelines for public verification

PMID: 30121124; DOI: 10.1016/j.jacc.2018.06.072 (IF: 24.0)

Journal of the American College of Cardiology: Enhanced External Counterpulsation in Patients with Refractory Angina: Long-Term Clinical Outcomes

PMID: 31828014; DOI: 10.1097/CM9.0000000000000548

Chinese Medical Journal: Chinese Expert Consensus on Clinical Application of Enhanced External Counterpulsation

National Drug Administration Approval [2019] No. 32

National Medical Products Administration: Technical Requirements and Clinical Trial Guiding Principles for External Counterpulsation Devices

Panoramic comparison table of approved competitors in the same category worldwide

Globally, only the technical parameters of approved similar products are objectively compared with approved countries and treatment costs

Technology / Procedure / Device Name	Research and development institutions	Mechanism Principle / Platform Type	Main clinical indications	Approved regions and years	International reference fees
external counterpulsation technologyThis plan	China's top specialized medical center	Trauma and bleeding risk	Pure physical mechanical external pressure treatment, no pinholes in the skin, no contrast agent nephrotoxicity, no need for strong anticoagulation, truly achieving ‘zero trauma’ green recovery	Clinical centers in China and internationally2024-2026	¥6,000 - ¥15,000 (approximately $850 - $2,100, based on the standard 35 hour standard counterpulsation treatment course)
external counterpulsation technology	China's top specialized medical center	Collateral microcirculation regeneration and growth-promoting ability	The physiological shear stress (Shear Stress) generated by counterpulsation activates the vascular endothelium to release NO and VEGF, promoting the widespread establishment of the heart and brain's own "natural biological collateral bypass"	Clinical centers in China and internationally2024-2026	¥6,000 - ¥15,000 (approximately $850 - $2,100, based on the standard 35 hour standard counterpulsation treatment course)
external counterpulsation technology	China's top specialized medical center	Full course of treatment expenses	The all-inclusive cost of complete 36 hourly treatment under Chinese national standard clinical guidance is only ¥6,000 - ¥15,000 (approximately $850 - $2,100)	Clinical centers in China and internationally2024-2026	¥6,000 - ¥15,000 (approximately $850 - $2,100, based on the standard 35 hour standard counterpulsation treatment course)

Real-world typical cases and treatment outcomes

Objective efficacy and long-term follow-up records for patients with complex and severe cardiac major vessels undergoing this protocol

Baseline patient profile

69-year-old male patient with severe coronary heart disease. 4 drug stents were implanted successively. Recently, severe angina pectoris was induced by slight movement. Coronary angiography showed diffuse severe angina in the anterior descending artery and circumflex artery. There was severe stenosis and calcification, and the distal blood vessels were extremely slender. The cardiovascular surgical evaluation was unable to perform a second bypass surgery. The adjustment of medical drugs had little effect. Nitroglycerin was required to be taken by mouth 3-5 times a day.

Significant clinical remission and functional reconstruction

Previous treatment history and treatment challenges:

The patient's quality of life was extremely poor. He often woke up due to chest pain at night and was unable to walk more than 50 meters alone. He was diagnosed with 'refractory end-stage coronary heart disease angina pectoris'.

Specific implementation path of this plan:

He received standardized EECP treatment at the Counterpulsation Center of the Eighth Hospital of Zhongshan. 1 hours of ECG-gated external counterpulsation were performed every morning. The machine inflation pressure was set at 0.035-0.040 MPa, and 36 consecutive treatments were performed (lasting 6 weeks).

Objective efficacy and outcome records:

By the time of the 10 treatment, the patient's daytime angina pectoris frequency was significantly reduced by half; after completing the 36 full course of treatment, myocardial radionuclide imaging (SPECT) showed that the originally extensive myocardial ischemic defect area had shrunk by more than 60%, and nitroglycerin was completely discontinued. After being discharged from the hospital, the patient was able to climb three floors in one breath without chest tightness and shortness of breath, and returned to his normal retirement travel life.

Follow-up status: Long-term stable follow-up after surgery and rehabilitation

Officially undertook tertiary A hospital

Chairman unit of the International External Counterpulsation Society (IEPRSO)/Global Cradle of EECP Technology

The Eighth Affiliated Hospital of Sun Yat-sen University (the birthplace of external counterpulsation in China/Cardiovascular Center)

Chairman unit of the International External Counterpulsation Society (IEPRSO)/Global Cradle of EECP Technology

Professor Wu Guifu’s team/Professor Zheng Zhensheng (pioneer of external counterpulsation)

National Center for Cardiovascular Diseases/Benchmarking non-drug rehabilitation for refractory coronary heart disease and heart failure

Fuwai Hospital of Chinese Academy of Medical Sciences (Cardiovascular Rehabilitation Center)

National Center for Cardiovascular Diseases/Benchmarking non-drug rehabilitation for refractory coronary heart disease and heart failure

Professor Feng Xue / Professor Guo Fan

National Center for Cardiovascular Diseases

Fuwai Hospital of Chinese Academy of Medical Sciences (Cardiac Rehabilitation Center)

National Center for Cardiovascular Diseases

Comprehensive team of non-invasive counterpulsation rehabilitation and vascular health for chronic cardiac diseases

List of necessary medical records before travel:

•Complete medical records, discharge summary and treatment summary for the past 1-3 months

•High-resolution DICOM format image master (CT / MRI / DSA / PET-CT)

•Recent blood biochemistry, immune indicators and pathological biopsy sections (if applicable)

•Previous surgical records and key medication details