Corvia Medical receives FDA investigational device exemption approval for REDUCE LAP-HF study

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Corvia Medical has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) for a multicentre clinical 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,” comments Martin Leon, director of the Centre 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 randomised 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, multicentre, randomised 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 enrol patients at up to 20 sites in the USA and up to 8 sites outside the USA.

“The IDE approval and strategic funding solidify our commitment to advancing our breakthrough therapy for patients suffering from chronic heart failure,” says George Fazio, president and chief executive officer 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 commercialisation.”