Interatrial Shunt Helps Decompress Failing Heart

Once in place, a permanent passage is created in the septum between the atria, resulting in reduction in HF symptoms, improved quality of life, and reduced hospitalization rates.

The IASD, which has been granted “Breakthrough Device” designation by the U.S. Food and Drug Administration (FDA), is being studied in the REDUCE LAP-HF II study, a large multi-national prospective, double-blind, sham-controlled trial randomizing 608 HFpEF and HFmrEF patients in the United States, European Union, Australia, Japan, and Canada. One-year follow-up data of the IASD clinical study, held in 64 patients implanted at 18 centers, demonstrated shunt patency for all participants who received the implant.

“Receiving Breakthrough Device designation from the FDA underscores the significant unmet need for more effective treatment options for heart failure patients,” said George Fazio, President and CEO of Corvia Medical. “We look forward to continuing our work with the FDA through our ongoing pivotal trial in more than 100 hospitals, and providing the clinical evidence which will accelerate the timeline to bring the IASD to the U.S. market.”

There are two types of HF; HF with reduced ejection fraction (HFrEF, systolic heart failure), and heart failure with preserved or mid‐range ejection fraction (HFpEF/HFmrEF), previously called diastolic heart failure. HFpEF accounts for approximately 50% of all HF, but treatment options are limited, consisting mainly of diuretics and fluid balance control. Although the pathophysiology of HFpEF is complex, many of the symptoms are a result of excessive rises in left atrial pressure, in particular during exercise.

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