Atrial Flow Regulator Receives FDA’s Breakthrough Device Designation
Occlutech’s atrial flow regulator (AFR) — a cardiac implant — received breakthrough device designation from the U.S. Food and Drug Administration for the treatment of pulmonary arterial hypertension (PAH).
Breakthrough status is given to medical equipment that offer significant advantages over currently available options for the treatment of irreversibly debilitating or life-threatening conditions. The designation is intended to support and accelerate the device’s development and approval.
“It is an important milestone for us to have received this breakthrough designation,” Sabine Bois, co-CEO of Occlutech Group, said in a press release. “We are very proud and excited to work closely with the FDA in this opportunity to develop an important new therapy that positively impacts the lives of critically ill patients.”
PAH is characterized by high blood pressure in the pulmonary artery — the vessel that drives blood directly from the heart to the lungs — and can potentially result in heart failure.
The AFR device is designed to lower the blood pressure in the heart. It is a small implantable device made of nitinol, a metal alloy widely used in implantable cardiac devices. The device is implanted using minimally invasive (non-surgical) procedures via the femoral vein, into the interatrial septum of the heart where it controls the blood flow between the heart’s top chambers — the left and right atria.
In the case of PAH, the device has a two-disc configuration with a central fenestration to allow blood to flow from the right high-pressure atrium to the left atrium (low-pressure) of the heart.
According to Occlutech, the resulting “decompression” of the heart is expected to lead to a reduction in disease symptoms and to improve patients’ exercise capacity and quality of life.
For PAH patients, the AFR device is available with three different waist-heights to accommodate varying thicknesses of the atrial septal wall, and also in four different disc sizes based on the patient’s cardiac anatomy. Furthermore, the device is available with four different fenestration diameters.
The AFR device has been approved in Europe for the treatment of heart failure, a serious condition characterized by the heart’s inability to pump an adequate supply of blood to the body. Data from this patient population has shown that the device — in an interatrial left to right configuration — led to health improvements in most patients, namely in exercise capacity, quality of life, and functional New York Heart Association class.
It is not yet approved for use in the United States.