US-based medical device company Corvia Medical has secured CE mark approval and has enrolled the first patients in the clinical study of its InterAtrial Shunt Device (IASD) to treat heart failure with preserved ejection fraction (HFpEF), previously known as diastolic heart failure.
The CE mark will authorise the company to market the product in the European Union.
In addition, the 64 patient CE mark study, labelled as the REDUCE LAP-HF TRIAL, has exhibited fewer heart failure symptoms with patients being able to exercise for a longer duration following an IASD implantation into them.
The company has also enrolled the first group of patients on the follow-on multicentre, randomised controlled study, REDUCE LAP-HF I TRIAL to assess the effect of the IASD on patients at up to 20 sites in the US and eight sites outside the US.
Ohio State University Richard M. Ross Heart Hospital heart failure cardiologist and principal investigator Dr Rami Kahwash randomised the first patient in the US.
Dr Kahwash said: "Finding new and effective treatment options for patients with HFpEF is crucial because none of the therapeutic treatments that work for systolic heart failure are effective for HFpEF.
"I have performed thousands of RHCs [right heart catheterisations] on patients with HFpEF only to prove the diagnosis and then walk away with nothing to offer them.
"This has made me very committed to finding hope for these patients and that is what I see in this trial."
The IASD also termed as the Corvia Atrial Decompression System, is claimed being world's first transcatheter device to treat heart failure with preserved or mildly reduced ejection fraction (HFpEF).
The IASD is implanted after creating a small opening in the atrial septum 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.
Triggering a continuous and dynamic decompression of the left atrium, the IASD intends to eliminate heart failure symptoms and quality of life, decrease heart failure hospitalisation rates, and subsequently decrease the overall cost burden of managing heart failure patients.