PR91152

SCHAFFHAUSEN, Switzerland, Aug. 16, 2021 /PRNewswire=KYODO JBN/ --

Occlutech Holding AG ("Occlutech"), one of the world´s leading providers of

minimally invasive structural heart disease devices, announces the conditional

U.S. Food and Drug Administration ("FDA") approval of its Investigational

Device Exemption ("IDE") application to conduct a pivotal study, OCCLUFLEX,

comparing Patent Foramen Ovale ("PFO") closure by Occlutech's Flex II PFO

Occluder to the standard of care for PFO occlusion in patients with cryptogenic

stroke.

Occlutech today announces that the FDA has conditionally granted Occlutech an

IDE for a prospective, randomized, multi-center, controlled, clinical study

("OCCLUFLEX"), which aims to compare outcomes of PFO closure by Occlutech's

Flex II PFO Occluder to the standard of care in patients with cryptogenic

stroke.

The IDE allows Occlutech's PFO Occluder to be used in a clinical study to

collect safety and effectiveness data to support a Premarket Approval ("PMA").

This marks a key milestone in Occlutech's strategy of capturing the significant

U.S. market opportunity for the PFO Occluder, which today has regulatory

approvals in over 60 markets.

Sabine Bois, CEO Occlutech, comments:

"The conditional FDA approval is another significant milestone in our plan to

enter the U.S. Accounting for approximately 30 percent of the global Structural

Heart Defect occluder market, and characterized by an attractive pricing and

reimbursement system, the U.S. is a potential key market for Occlutech. Earlier

this year we set up a subsidiary in Chicago, focusing on marketing,

distribution, logistics and sales. We expect to complete the enrollment of

patients in 2025 while finalizing the Premarket Approval and anticipate to

receive an FDA market approval for the U.S. in 2026."

Patient enrollment is expected to commence during the second half of 2021. The

study's primary and secondary endpoints, PFO Closure and recurrent stroke,

respectively, will be evaluated at the 12-month patient follow-up.

About PFO

PFO is a common structural heart defect in which the foramen ovale does not

seal completely after birth, resulting in a flap opening between the left and

right atria of the heart. PFOs occurs in approximately 25 percent of the

general population.[1]

Blood clots that commonly develop outside the heart may pass directly through

the PFO from the right atrium without passing through the lungs, where they are

normally filtered out of the blood. Such clots may cause an occlusion of a

small blood vessel and, if located in the brain, cause a stroke.

Occlutech's Flex II PFO Occluder, which has regulatory approvals in over 60

markets globally, enables physicians to close the Patent Foramen Ovale through

a minimally invasive procedure. Occlutech's PFO Occluder is proven and

effective for stroke prevention, reducing the relative risk of recurrent stroke

by 97 percent.[2] The mean procedure time for PFO closure is less than 30

minutes with decreased fluoroscopic time[3] (X-ray exposure), contributing to

the device's excellent track-record of performance and safety.[4]

For additional information about the Company's products, the Occlutech PFO

Occluder, 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 provider of minimally invasive structural heart disease

devices. Occlutech develops, manufactures, and commercializes structural heart

and interatrial shunt products to improve the treatment of patients. Occlutech

has a broad and proven portfolio, with more than 135,000 products sold,

addressing congenital defects, stroke prevention and heart failure. Occlutech

markets and sells its structural heart and interatrial shunt products to

hospitals and clinics in approximately 85 countries through its direct sales

organization and international network of distribution partners. Occlutech has

approximately 250 employees and maintains manufacturing and R&D facilities in

Jena, Germany and Istanbul, Turkey, with a global supply and customer support

hub located in Helsingborg, Sweden.

Contact

Claudia Scalia

Marketing Communications Manager

Tel: +46 735 199782  

claudia.scalia@occlutech.com

Stefan Kleidon

Vice President Sales & Marketing

Tel: +49 176 31514136  

stefan.kleidon@occlutech.com

[1] Krasuski, R. (2017). Closure of Patent Foramen Ovale After Stroke: Who

Benefits? [PowerPoint presentation]. SlideShare.

https://www.slideshare.net/DukeHeartCenter/closure-of-patent-foramen-ovale-after-stroke-who-benefits

[2] Patent Foramen Ovale Closure or Anticoagulation vs. Antiplatelets after

Stroke Mas et al. (N Engl J Med 2017; 377:1011-1021).

[3] Trabattoni, D., Gaspardone, A., Sgueglia, G. A., Fabbiocchi, F., Gioffrè,

G., Montorsi, P., Calligaris, G., Iamele, M., De Santis, A., & Bartorelli, A.

L. (2017). AMPLATZER versus Figulla occluder for transcatheter patent foramen

ovale closure. EuroIntervention : journal of EuroPCR in collaboration with the

Working Group on Interventional Cardiology of the European Society of

Cardiology, 12(17), 2092–2099. https://doi.org/10.4244/EIJ-D-15-00499

[4] Snijder, R., Renes, L. E., Suttorp, M. J., Ten Berg, J. M., & Post, M. C.

(2019). Percutaneous patent foramen ovale closure using the Occlutech Figulla

device: More than 1,300 patient-years of follow up. Catheterization and

cardiovascular interventions : official journal of the Society for Cardiac

Angiography & Interventions, 93(6), 1080–1084. https://doi.org/10.1002/ccd.27984

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Source: Occlutech International