Austin, Texas-based Alleviant develops a no-implant atrial shunt for treating heart failure. That includes reduced ejection fraction (HFrEF), a common form of heart failure. Its novel shunt leaves behind no permanent implant in the body.

The IDE allows the company to begin a pivotal trial focused on patients with HFrEF. Alleviant can now investigate its technology for patients with the full spectrum of heart failure. That includes both reduced and preserved ejection fraction (HFpEF), for which it already holds FDA breakthrough designation.

Alleviant’s transcatheter device uses a short pulse of energy to create a durable passage between the heart’s left and right atrium. It aims to reduce excess pressure within the left atrium through a less-invasive approach.