Alleviant Medical has raised $75 million to support a global pivotal trial of its catheter-delivered interatrial shunt to treat heart failure.
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 treatment option to millions of patients suffering from heart failure, and this highly informed study is a critical step forward,” CEO Adam Berman said in a news release. “We could not ask for a stronger group of institutional and strategic healthcare investors as we accelerate our global efforts to bring this technology to patients.”
Read more in our sister publication Medical Tubing + Extrusion.