The Corvia Medical InterAtrial Shunt Device (IASD®) System II is indicated for the improvement in quality of life and reduction of heart failure related symptoms and events in patients with heart failure with preserved (HFpEF) or mid-range ejection fraction (HFmrEF) with elevated left atrial pressures, who remain symptomatic despite standard Guideline Directed Medical Therapy. The implant is supplied preloaded onto a delivery system consisting of a delivery catheter with an integrated handle. The implant is placed across the interatrial septum using a percutaneous trans-catheter approach. The procedure is performed in the cardiac catheterization laboratory by an interventional cardiologist. In the setting of high left atrial pressure, the center barrel section allows L→R flow to decompress the left atrium.
CRITERIA LIST/ QUALIFICATIONS:
> 40 years NYHA class II with prior history of >NYHA II, ambulatory class IV within past 12 months AND > 1 HF hospital admission, or treatment with IV diuretics or intensification of oral diuresis for HF in a healthcare facility; or NT-pro BNP elevation (per specific guidelines)
Ongoing stable GDMT HF management with no significant changes
LV EF > 40% within past 6 months, without documented EF < 30% in the past 5 years
Elevated PCWP as determined during supine ergometer exercise > 25mm Hg and > RAP by > 5 mm Hg