Clinical Evidence

100%

technical success and procedural safety

0%

device-related serious adverse events

>12 months

of patient follow-up data confirming
shunt patency and durability with
sustained improvement in clinical
(symptomatic and functional) outcomes.

Hemodynamic Measures

Exercise intolerance is a defining characteristic of HFpEF. A marked rise in pulmonary capillary wedge pressure (PCWP, a surrogate measure for left atrial pressure) during exertion is thought to be a key cause of exercise intolerance.¹
Significant reduction of peak exercise pulmonary capillary wedge pressure (PCWP) by 5.4 mmHg.

Functional Capacity

The NYHA Classification system is a simple and widely used tool that classifies patients with heart failure into one of four classes according to their degree of symptoms at rest and with activity.¹
The 6-Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.¹
At 6 months, improvement in NYHA classification by one or more classes was reported in 66.7% of patients. Six-minute walk distance increased 37% (101 meters).

Quality of Life

The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item self-administered questionnaire developed to independently measure the patient’s perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life (QOL) within a 2-week recall period. The Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.¹
At 6 months, subjects reported 83% improvement in their Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score.

Safety

No reported incidence of cardiovascular death or major cardiovascular-related adverse events, embolic stroke, systemic or pulmonary embolism, or any device-related or access site complications.

100% Technical Success and Procedural Safety

Successful shunt creation following transseptal puncture with echocardiographic confirmation of left-to-right flow and confirmation of excised septal tissue with no procedure-related serious adverse cardiac events.

100% Shunt Patency and Durability

Echocardiographic confirmation of left-to-right flow detected at one year or beyond.