Occlutech takes important step towards approval in China
PR89849
SCHAFFHAUSEN, Switzerland, June 1, 2021 /PRNewswire=KYODO JBN/ --
Occlutech AG ("Occlutech" or the "Company") today announces that the planned
recruitment of 180 patients has been reached in the Company's trial in China
for its ASD Occluder. The Occlutech ASD Occluder is used in the treatment of
Atrial Septal Defects (ASD), which is a congenital heart condition. The
completion of the patient recruitment represents a significant milestone in the
process towards approval of Occlutech's ASD Occluder in China. The trial is
conducted as a multicenter, randomized, prospective trial. It is commencing now
and is supporting Occlutech's application for market approval of the ASD
Occluder in China. Once the 12 months follow-up for all patients is completed
the Company expects to file for regulatory approval by the Chinese National
Medical Products Administration (NMPA).
An approval in China will be an important addition to Occlutech's global
expansion. The ASD Occluder is today approved in more than 60 countries
worldwide, among others Canada, Japan, South Korea and CE marked countries like
Germany, France and Sweden. Furthermore, the ASD Occluder is in its final
review with the FDA in the premarket approval (PMA) application in the United
States.
Sabine Bois, CEO Occlutech Group, comments:
"To reach the intended recruitment goal despite the challenging impact of the
Corona pandemic is an important milestone for Occlutech. The expansion towards
China is a key part of our strategic ambition to drive sales growth over the
coming years and the trial is another important step to bring us closer to file
for market approval by the Chinese National Medical Products Administration
(NMPA), once the 12 months follow up for all patients is completed."
About Atrial Septal Defect (ASD) Occluders
Atrial septal occluders are minimally invasive cardiac devices, addressing
congenital heart defects. Atrial Septal Defect (ASD) is one of the most common
types of congenital heart diseases and formed due to an unclosed connection
between the upper chambers of the heart appearing during fetal development.
For additional information about the Company's products, the Occlutech ASD, or
to inquire about participation in our patient registries, please visit
Occlutech's website at www.occlutech.com, or contact us directly at
info@occlutech.com.
About Occlutech
Occlutech is a leading specialist in minimally invasive cardiac devices,
addressing congenital heart defects, stroke prevention and heart failure. Since
2003, we have been developing, manufacturing, and commercializing structural
heart and interatrial shunt products. We have a track record of over 15 years
of gaining market share, developing and launching innovative products and
building solid market positions. Occlutech has a broad and proven portfolio
with 10 CE marked products covered by over 200 patents. We market and sell our
products to hospitals and clinics in over 85 countries.
Occlutech maintains manufacturing and R&D facilities in Germany and Turkey,
with a global supply, customer support hub located in Sweden.
Contact
Claudia Scalia
Marketing Communications Manager Occlutech Group
Tel: +46 735 199782
Email: claudia.scalia@occlutech.com
Stefan Kleidon
Vice President Sales & Marketing Occlutech Group
Tel: +49 176 31514136
Email: stefan.kleidon@occlutech.com
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SOURCE: Occlutech International
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