Corvia Medical has received CE mark approval for its InterAtrial shunt device (IASD) to treat heart failure with preserved ejection fraction (HFpEF) or diastolic heart failure.
Also called as Corvia atrial decompression system, the IASD is claimed to be the first device for the treatment of heart failure with HFpEF.
The IASD implant will be deployed, after creating a small opening in the atrial septum. It helps to create a passage between the left and right atria, which allows the left atrium to decompress at rest and physical activity, enabling in reducing left atrial pressure.
According to the company, the IASD aims to improve heart failure symptoms by facilitating continuous and dynamic decompression of the left atrium.
The approval was based on the 64-patient Reduce Lap-HF trial, which demonstrated fewer heart failure symptoms in patients following IASD implantation.
Corvia has also enrolled first group of patients in the follow-on Reduce Lap-HF I trial. It is a multicenter and randomized controlled study that will assess the IASD in patients at up to 20 sites in the US, as well as eight sites outside the US.
Corvia Medical president and CEO George Fazio said: "We are very excited with the start of the randomized study and expect enrollment to progress quickly with the world-class US and International sites that are participating.
"CE mark approval is a significant milestone for Corvia as it sets the groundwork for our reimbursement and brings us one step closer to bringing our innovative technology to the millions of patients who suffer from heart failure."
Image: Corvia Medical has secured CE mark approval for InterAtrial shunt device to treat heart failure with preserved ejection fraction. Photo: courtesy of dream designs / FreeDigitalPhotos.net.