CAUTION–Investigational Device. Limited by United States Law to Investigational Use.
TEWKSBURY, MA – March 11, 2019— Corvia Medical, Inc., a privately-held company with a first-in-class structural heart device to treat heart failure, today announced it has entered into an agreement with Edwards Lifesciences. The agreement includes a $35 million investment and provides the exclusive option for Edwards to acquire the company at a later date. Funds will be used to complete the REDUCE LAP-HF II clinical trial of the InterAtrial Shunt Device (IASD®), the world’s first transcatheter device for the treatment of heart failure with preserved (HFpEF) and mid-range ejection fraction (HFmrEF).
“We are extremely pleased to have the support of the global leader in patient-focused innovations for structural heart disease as we continue to advance this novel treatment for heart failure,” commented George Fazio, President and CEO of Corvia Medical. “We are proud of our accomplishments to date and look forward to completing the pivotal study with the support of our global clinical investigators.”
The IASD is designed to provide continuous and dynamic decompression of the left atrium, which may reduce symptoms and slow the progression of heart failure. The CE Mark designation was received in 2016 and NUB1 reimbursement status in Germany earlier this year. The device is being studied in REDUCE LAP-HF II, a large multi-national prospective, double-blind, sham-controlled trial randomizing 608 HFpEF and HFmrEF patients in the United States, European Union, Australia and Canada. Recruitment is ongoing.
About the InterAtrial Shunt Device (IASD®)
The Interatrial Shunt Device is the world’s first transcatheter device approved in the European Union to treat heart failure with preserved (HFpEF) or mid-range ejection fraction (HFmrEF). 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 during 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 an investigational device and not available for commercial distribution in the United States.
About Corvia Medical, Inc.
Corvia Medical, 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 Ventures, Edwards Lifesciences and an undisclosed strategic investor. For more information, please visit http://corviamedical.com/.