The FDA provided the Austin, Texas–based company with an Investigational Device Exemption for the clinical trial in November 2022. Researchers have designed the ALLAY-HF study to demonstrate the safety and effectiveness of the Alleviant System.
The Alleviant System is a transcatheter device that uses a short pulse of energy to create a durable passage between the heart’s left and right atrium. The goal is to reduce excess pressure within the left atrium. Alleviant Medical officials describe it as a less-invasive approach.
“Alleviant’s mission is to bring a safe, effective no-implant t…