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 mortalitiescompared 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.

ConFlow MedTech's FreeFlow percutaneous atrial septal shunt represents a significant leap forward in product design and performance.