Angiolutions has announced that the first patient has been successfully treated with its investigational A3-Shield system in the PRINCIPIIS FIH trial, a first-in-human (FIH) study evaluating the device’s safety and effectiveness.
The trial is being conducted at several centres in Tashkent, Uzbekistan, and is designed to evaluate the device—an implant that stops AAA growth by locally modulating aortic pulse waves—as an early interventional option for patients with small abdominal aortic aneurysms (AAAs).
“The first procedure in PRINCIPIIS-FIH is a major milestone for Angiolutions and for patients living with small AAAs,” said Uwe Raaz, chief executive officer of Angiolutions. “For too long, these patients have had to accept a ‘watch and wait’ approach in a progressive, life-threatening disease. With the A3-Shield system, we aim to open a new therapeutic window where we can intervene earlier and intercept the disease in a relatively benign state.”
“Treating the first patient in PRINCIPIIS-FIH is an important step toward offering an earlier, less invasive option to patients with AAAs who are currently managed by surveillance alone,” said Hubert Schelzig, director of the Clinic for Vascular and Endovascular Surgery at the University Hospital Düsseldorf (Düsseldorf, Germany) and a member of the medical board at Angiolutions. “By targeting a root biomechanical driver of AAA progression, the A3-Shield system aims to reduce the risk of future rupture and limit the need for complex aortic repair. The data from PRINCIPIIS-FIH will help us determine how this concept can be translated into routine clinical practice.”
