> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Breakthrough Designation for Heart Failure Shunt
- URL: https://www.fdaweb.com/breakthrough-designation-for-heart-failure-shunt/
- Published: 2019-08-15T12:00:00.000Z
- Updated: 2026-09-15T01:44:04.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144779

FDA has granted V-Wave a breakthrough device designation for its interatrial shunt for heart failure (HF). The implanted interatrial shunt is being evaluated in a global, randomized, controlled, double-blinded, 500 patient [pivotal trial](https://c212.net/c/link/?t=0&l=en&o=2552918-1&h=2706152438&u=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT03499236&a=global%2C+randomized%2C+controlled%2C+double-blinded%2C+500+patient+pivotal+IDE+trial+called+RELIEVE-HF&ref=fdaweb.com) called RELIEVE-HF. The study is enrolling advanced HF patients with preserved or reduced left ventricular ejection fraction who remain symptomatic despite the use of guideline directed medical and device therapies, according to the company. The device is intended to relieve excessive pressure in the left-side of the heart thereby reducing the build-up of fluid in the lungs, which is known to be the most common reason for HF hospitalizations and exercise limitation, it says.