NEW ORLEANS, Nov. 16, 2016 /PRNewswire/ -- Corvia Medical, Inc., a privately-held medical device company developing first-in-class structural heart devices, today announced one-year follow-up data from the REDUCE LAP-HF clinical study of its InterAtrial Shunt Device (IASD®). The IASD is the world's first transcatheter device designed to treat heart failure with preserved ejection fraction (HFpEF), previously called diastolic heart failure. Data was presented in the late-breaking sessions at the American Heart Association Scientific Sessions 2016.
"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," commented Prof. David Kaye, Head of the Cardiology Division at the Baker IDI Heart and Diabetes Institute and Senior Cardiologist at The Alfred Hospital in Melbourne, Australia. "Elevated left atrial pressures are a key contributor to heart failure symptoms. The Corvia IASD System is designed to facilitate continuous and dynamic decompression of the left atrium to improve exercise capacity and quality of life for patients with HFpEF. The compelling one-year data demonstrating sustained benefit shows the clear promise of this breakthrough technology."
The results of the ongoing 64-patient study confirm a good safety profile, sustained device performance (blood flow from the left to right atrium) 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 6-minute walk distance improved over 30 meters, from 331 meters to 363 meters (p=0.001);
"The presentation of this one-year data at AHA is another exciting milestone for Corvia," said Jan Komtebedde, Senior Vice President and Chief Medical Officer at Corvia Medical. "We are encouraged that the longer-term follow-up continues to demonstrate statistically significant, and even more importantly, clinically-meaningful results as we aim to improve the lives of patients around the world who suffer from heart failure."
About the InterAtrial Shunt Device (IASD®) The InterAtrial Shunt Device (IASD) is the world's first transcatheter device approved in the European Union to treat heart failure with preserved or mildly reduced ejection fraction (HFpEF). After creating a small opening in the atrial septum, the IASD 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 IASD aims to improve heart failure symptoms and quality of life, decrease heart failure hospitalization rates, and reduce the overall cost burden of managing heart failure patients. For more information, please visit http://treatmyheartfailure.com/. The IASD is not available for commercial distribution in the United States.
About Corvia Medical, Inc. Corvia Medical, Inc., formerly DC Devices Inc., is dedicated to revolutionizing the treatment of heart failure with first-in-class transcatheter structural heart devices. Privately held, the company is backed by Third Rock Ventures, General Catalyst Partners, AccelMed, Lumira Capital and an undisclosed strategic investor. For more information, please visit http://corviamedical.com/.