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Tuesday, September 27, 2022

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FDA Conditionally Grants Occlutech an IDE for PFO Study in U.S.

Occlutech in the news:

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]


References

[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 Cardiology12(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

Occlutech Atrial Flow Regulator news here.

 

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