On May 25, 2022, a team led by Academician Ge Junbo and Director Zhou Daxin at Zhongshan Hospital Affiliated to Fudan University applied the FreeFlow® percutaneous atrial septal shunt developed by ConFlow MedTech in the treatment of the inaugural patient with pulmonary arterial hypertension (PAH). Currently, 5 PAH subjects have been successfully enrolled, with 2 having completed a 12-month post-surgery follow-up, showing positive clinical data.
Patient Basic Profile & History
49 year old, female, 65kg, 165cm.
Admitted for the diagnosis of pulmonary arterial hypertension, repair of an atrial septal defect, and cardiac radiofrequency ablation. After evaluation by the research team, the patient was enrolled in a clinical trial investigating the FreeFlow® percutaneous atrial septal shunt. The percutaneous atrial septal shunt implantation procedure was successfully performed on August 17, 2022
Preoperative: The patient presented with severe symptoms, making it impossible to effectively measure her 6-minute walking distance. NT-proBNP levels were elevated at 5229 pg/ml, and the patient was classified as NYHA grade III. Intraoperatively, a 7mm instrument specification was applied. Immediate post-surgery ultrasound confirmed appropriate shunt placement with stable right-to-left shunt flow. Discharge examination results indicated an improvement in the patient's clinical symptoms of pulmonary hypertension.
Intraoperative release
24-hour postoperative ultrasound
Ultrasound 6 months after surgery
Ultrasound 12 months postoperatively
12-Month Clinical Follow-up:
At the 12-month post-surgery follow-up, the patient reported no discomfort, maintained postive mental state, and experienced a significant enhancement in her quality of life and physical condition compared to her preoperative state.
The follow-up examination revealed a remarkable improvement in the subject's motor function, as evidenced by a 6-minute walking distance of 314 meters. The KCCQ score also demonstrated a substantial increase in the subject's quality of life. Meanwhile, NT-proBNP levels decreased to 2730 pg/ml, and the patient's NYHA classification improved to grade II. Parameters such as pulmonary artery mean pressure and cardiac structural indicators revealed that the patient's condition had not worsened. The glomerular filtration rate increased, and cardiac ultrasound findings revealed no significant changes in position, shape, or right-to-left shunt flow rate compared to the immediate post-surgery assessment. Furthermore, a comprehensive analysis of clinical follow-up data from relevant examinations at 3 and 6 months post-surgery consistently demonstrated improvements in clinical symptoms, motor function, and quality of life for the patient.
FreeFlow® Percutaneous Atrial Septal Shunt: National Multicenter Registered Clinical Trial has been initiated. Patients meeting the following criteria are eligible to participate in this study:
- Age Range: 18 to 70 years, regardless of gender;
- 10 mmHg ≤ mean right atrial pressure (mRAP) ≤ 20 mmHg;
- The patient suffers from severe idiopathic pulmonary hypertension (mean pulmonary artery pressure>45 mmHg);
- WHO grade III or IV;
- NT proBNP ≥ 650 ng/L;
- The subjects are informed of the nature of this study and agree to participate in all the requirements of this study, signing the informed consent form, and agreeing to complete the follow-up and the required examinations during follow-up.
ConFlow MedTech, in collaboration with researchers from various research centers, will rigorously adhere to stringent inclusion criteria for study participants. This approach aims to generate more robust clinical data, thereby bolstering the efficacy and safety profile of our product. Ultimately, this effort is geared towards benefiting a broader population of individuals afflicted with pulmonary arterial hypertension (PAH)
Pulmonary arterial hypertension
PAH is a complex clinical and pathophysiological syndrome deriving from diverse etiologies and distinct pathogenic mechanisms, resulting in elevated pulmonary vascular resistance and pulmonary arterial pressure. It represents a grave, progressive, irreversible, and ultimately fatal condition.
While in recent years, tremendous breakthroughs have been achieved in pharmacological and therapeutic approaches for various forms of PAH, a substantial cohort of patients continues to experience disease progression despite optimal drug regimens. This deterioration negatively impacts patients’ quality of life, increases hospital readmission rates, and escalates healthcare expenditures. The annual mortality for idiopathic pulmonary arterial hypertension (IPAH) stands at approximately 10%, with no known cure. Certain PAH subtypes, such as scleroderma-related PAH, exhibit even higher mortalities. For patients resistant to pharmacotherapy and deemed high-risk, emergency dual lung transplantation remains the sole recourse. Regrettably, most PAH patients are not candidates for this procedure, as only 3% of individuals with pulmonary arterial hypertension are eligible for lung transplantation. Furthermore, although the median post-transplant survival period is 6.7 years, PAH patients still face higher mortalities compared to those with other medical conditions.
At present, pulmonary arterial hypertension (PAH) treatment options include general measures, basic therapy, specific therapy , as well as balloon atrial septostomy (BAS) and lung transplantation. BAS involves creating a controlled right-to-left shunt through an atrial septal balloon to reduce right heart pressure and alleviate right heart failure. However, an excessively large shunt can lead to acute severe hypoxia and an increased risk of mortality. Conversely, a too-small shunt may result in rapid spontaneous healing in approximately 25% of atrial septal stoma patients, necessitating a repeat BAS procedure. Therefore, precise flow rate control to limit the right-to-left shunt is of great importance. The development of atrial septal shunts tailored for this purpose represents a burgeoning frontier in PAH treatment.
Key Features of FreeFlow® Percutaneous Atrial Septal Shunt
- The world's first atrial septal shunt featuring a polymer membrane for rapid endothelialization and secondary recycling.
- Distinguished by its innovative elliptical disc design, offering a more compact implant size.
- Engineered with a range of aperture options, including 5mm, 7mm, 9mm, and 11mm, to better cater to diverse patient treatment requirements.
- Equipped with an 8-10F delivery system, incorporating a unique bending angle to facilitate seamless surgical procedures.
- Our project has applied for 2 invention patents, 4 utility model patents (3 authorized), and 6 design patents (5 authorized) to date.
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September 17,2021Celebrating its one-year milestone, ConFlow MedTech successfully concluded its first-anniversary event, joined by supporters and partners.
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July 24,2023Good News | ConFlow MedTech was awarded as "Specialized and Sophisticated SME" in Shanghai City
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September 18,2023Thank you for being with us as we celebrate the third anniversary of ConFlow MedTech's establishment!
Pursue further excellence!
