Corvia Medical has announced one-year follow-up data from the REDUCE LAP-HF clinical study of its InterAtrial shunt device. The device is the world’s first transcatheter device designed to treat heart failure with preserved ejection fraction. The data were presented in the late-breaking sessions at the 2016 American Heart Association (AHA) scientific sessions (12–16 November, New Orleans, USA).
The results of the ongoing 64-patient study confirm a good safety profile, sustained device performance and clinically meaningful patient-focused outcomes including fewer heart failure symptoms, the ability to exercise longer, and a substantially improved quality of life. Highlights include:
- Median New York Heart Association (NYHA) functional class improved from 3 to 2 (p<0.001)
- Mean quality of life score (Minnesota Living with Heart Failure questionnaire) improved 15 points from 49 to 34 (p<0.001)
- Mean six-minute walk distance improved over 30m, from 331m to 363m (p=0.001)
David Kaye (Baker IDI Heart and Diabetes Institute; The Alfred Hospital, Melbourne, Australia) comments: “Patients with heart failure in the context of preserved ejection fraction currently have few, if any, effective treatment options. As such, there is a major unmet clinical need for effective approaches to improve the quality of lives of these patients.Elevated left atrial pressures are a key contributor to heart failure symptoms. The Corvia InterAtrial shunt device system is designed to facilitate continuous and dynamic decompression of the left atrium to improve exercise capacity and quality of life for patients with heart failure with preserved ejection fraction. The compelling one-year data demonstrating sustained benefit shows the clear promise of this breakthrough technology.”
A press release reports that the InterAtrial shunt device is approved in the European Union to treat heart failure with preserved or mildly reduced ejection fraction. It notes that after a small opening in the atrial septum is created, the device implant is deployed—forming a passage between the left and right atria that enables the left atrium to decompress at rest and physical activity, with the aim of lowering left atrial pressure. By facilitating continuous and dynamic decompression of the left atrium, the device aims to improve heart failure symptoms and quality of life, decrease heart failure hospitalisation rates, and reduce the overall cost burden of managing heart failure patients.