Occlutech takes important step towards approval in China
SCHAFFHAUSEN, Switzerland, June 1, 2021 / PRNewswire / – Occlutech AG (“Occlutech” or the “Company”) today announced that the planned enrollment of 180 patients has been achieved in the Company’s trial in China for its ASD occluder. The Occlutech ASD Occluder is used in the treatment of atrial septal abnormalities (ASD), which is a congenital heart disease. The completion of patient recruitment represents an important step in the approval process of the Occlutech ASD Occluder in China. The trial is being conducted as a prospective, multicenter, randomized trial. It starts now and supports Occlutech’s request for the Occluder ASD market approval in China. Once the 12-month follow-up for all patients is complete, the company plans to file for regulatory approval with the Chinese National Medical Products Administration (NMPA).
Approval in China will be an important addition to Occlutech’s global expansion. ASD Occluder is now approved in more than 60 countries around the world, among others Canada, Japan, South Korea and CE marked countries as Germany, France and Sweden. In addition, the ASD Occluder is in its final review with the FDA in the application for pre-market approval (PMA) in United States.
Sabine Bois, CEO of the Occlutech group, comments:
“Reaching the planned recruitment target despite the difficult impact of the Corona pandemic is an important step for Occlutech. China is a key part of our strategic ambition to drive sales growth over the next few years and the trial is another important step in moving us closer to the market approval record by the Chinese National Medical Products Administration (NMPA), a times the 12-month follow-up for all patients is completed. ”
About atrial septal defect occluders (ASDs)
Atrial septal obturators are minimally invasive heart devices, treating congenital heart defects. Atrial septal defect (ASD) is one of the most common types of congenital heart disease and is formed due to an unclosed connection between the upper chambers of the heart that appears during fetal development.
For more information about the company’s products, Occlutech ASD, or to inquire about participating in our patient registries, please visit the Occlutech website at www.occlutech.com, or contact us directly at [email protected]
Occlutech is a leading specialist in minimally invasive cardiac devices, treating congenital heart defects, stroke prevention and heart failure. Since 2003, we have been developing, manufacturing and marketing structural heart and interatrial shunt products. We have more than 15 years of experience in gaining market share, developing and launching innovative products and building solid positions in the market. Occlutech has a large proven portfolio with 10 CE marked products covered by more than 200 patents. We market and sell our products to hospitals and clinics in more than 85 countries.
Occlutech has manufacturing and R&D facilities in Germany and Turkey, with a global sourcing and customer support center located in Sweden.
Marketing Communications Manager Occlutech Group
Phone: +46 735 199782
E-mail: [email protected]
Vice-President Sales and Marketing Occlutech Group
Phone: +49 176 31514136
E-mail: [email protected]
SOURCE Occlutech International