Occlutech, a privately-held company, announced today that the US Food and Drug 
Administration (FDA) has granted the company a Breakthrough Device designation 
for its first-in-class, implantable Atrial Flow Regulator (AFR) for Pulmonary 
Arterial Hypertension (PAH).
 
PAH affects hundreds of thousands in the U.S. and globally and is resulting 
from changes in cells that causes damages of the lung arteries. 
Consequentially, the heart is forced to work harder to supply enough oxygen. 
The patient experiences symptoms such as shortness of breath, dizziness and 
fatigue. The severity of these symptoms usually correlates with progression of 
the disease and significantly reduced quality of life. Over time, the right 
ventricle enlarges to hold more blood and the additional strain gradually 
causes the heart to fail. By placing the Occlutech AFR device into the septum 
and creating a restrictive atrial septal opening by maintaining the correct 
sizing of a created shunt, the intra cardiac pressure is substantially reduced, 
thereby improving the heart's function.

Breakthrough Device Designations are aimed to accelerate the development, 
assessment, and approval of new treatments in severe diseases, including a 
prioritized review all the way through market approval.

“It is an important milestone for us to have received this breakthrough 
designation,” says Sabine Bois, Co-CEO Occlutech Group. “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.”

Occlutech is one of the leading companies in its field, with several major 
products including state-of-the-art PFO occluders, ASD occluders among others. 
Occlutech has sales of congenital and structural heart products in over 80 
countries and maintains manufacturing and R&D facilities in Jena, Germany and 
Istanbul, Turkey. Occlutech has developed many novel products and technologies 
to improve treatment of patients in these and related areas.

For additional information about the Company’s products, the Occlutech AFR, or 
to inquire about participation in our patient registries, please visit 
Occlutech's website at www.occlutech.com, or contact us directly at 
AFR@occlutech.com.


The AFR is not approved in the United States.  Product availability is subject 
to local regulatory clearance. The AFR is under clinical investigation for use 
in patients with pulmonary arterial hypertension and use in these patients is 
limited by applicable national laws.

Contact:
Sabine Bois
Co-CEO Occlutech Group
Mobile: +49 160 90792130
Email: sabine.bois@occlutech.com

Source: Occlutech International