Corvia Medical, a privately-held medical device company that developed a first-in-class transcatheter structural heart device to treat heart failure, announced that it has received Investigational Device Exemption (IDE) approval from the FDA for a multicenter study of the Company's InterAtrial Shunt Device (IASD®) for the treatment of heart failure.
The Company also announced that it has entered into an exclusive option-to-purchase agreement with an undisclosed strategic partner.
"Treating heart failure patients, especially those with preserved ejection fraction, continues to be a challenge as current pharmacological treatments are ineffective," commented Martin Leon, MD, Director of the Center for Interventional Vascular Therapy at Columbia University Medical Center in New York and chair of the Company’s Scientific Advisory Group.
"We expect the results of the REDUCE LAP-HF I randomized study to confirm the significant clinical benefits demonstrated in the observational studies and will show clinically meaningful improvements in NYHA functional class, exercise capacity, and quality of life for this patient population."
The REDUCE LAP-HF I study is a prospective, multicenter, randomized controlled study to evaluate the IASD® System to reduce elevated left atrial pressure in patients with heart failure with preserved ejection fraction, also known as diastolic heart failure. The study will enroll patients at up to 20 sites in the United States and up to 8 sites outside the United States.
"The IDE approval and strategic funding solidify our commitment to advancing our breakthrough therapy for patients suffering from chronic heart failure," said George Fazio, President and CEO of Corvia Medical.
"We look forward to providing physicians a technology that is designed to facilitate continuous and dynamic decompression of the left atrium and address the debilitating symptoms of heart failure." He continues, "We are especially pleased to have the support of a strategic partner with best-in-class global resources as we move this novel treatment toward international commercialization."
The Corvia™ Atrial Decompression System is the world’s first transcatheter device designed to treat heart failure with preserved ejection fraction (HFpEF). After creating a small opening in the atrial septum, the Corvia implant is deployed, forming a passage between the left and right atria that enables the left atrium to decompress with the aim of lowering left atrial pressure.
By facilitating continuous and dynamic decompression of the left atrium, the Corvia System 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.