FDA Grants NEXUS Aortic Arch Stent Graft System Breakthrough Designation

Summation

  • “This recognition is important for Endospan in that it allows FDA to expedite the review of an Investigational Device Exemption (IDE) study for the NEXUS Stent Graft System that is expected to start enrolling patients later in 2020.
  • The FDA's Breakthrough Device Designation Program is intended to provide timely access to medical devices that have the potential to provide a more effective treatment for life-threatening or irreversibly debilitating diseases or conditions by prioritizing review of its regulatory submissions, thereby expediting the device development process.
  • It will also allow prioritized review of a subsequent Pre-Market Approval (PMA) application at the conclusion of the study to seek approval to commercialize the device in the U.

Israeli based Endospan, (a pioneer in off-the-shelf endovascular repair of aortic arch disease) announced they were recently granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the NEXUS Aortic Arch Stent Graft System.

The FDA’s Breakthrough Device Designation Program is intended to provide timely access to medical devices that have the potential to provide a more effective treatment for life-threatening or irreversibly debilitating diseases or conditions by prioritizing review of its regulatory submissions, thereby expediting the device development process. The designation of NEXUSTM Aortic Arch Stent Graft System as a breakthrough device acknowledges the unmet need in this patient population and the potential for improvements over current standard treatments.

Minimally invasive techniques are standard-of-care for treating descending aortic disease and heart disease, but highly invasive, high-mortality open surgery is still being used in the difficult-to-treat aortic arch anatomy. The NEXUS™ Aortic Arch Stent Graft System is uniquely engineered to address this significant area of unmet clinical need. More than 120,000 patients suffer thoracic aortic arch disease every year in the USA and Europe, with only about 25% being diagnosed or treated. This global market opportunity is over $1.3 billion in a high average selling segment with no other off-the-shelf competition to the NEXUS™ technology.

“Receiving the Breakthrough Device Designation from FDA acknowledges our novel technology has the potential to provide a unique and innovative endovascular treatment for patients with aortic arch disease”, said Kevin Mayberry, CEO of Endospan. “This recognition is important for Endospan in that it allows FDA to expedite the review of an Investigational Device Exemption (IDE) study for the NEXUS Stent Graft System that is expected to start enrolling patients later in 2020. It will also allow prioritized review of a subsequent Pre-Market Approval (PMA) application at the conclusion of the study to seek approval to commercialize the device in the U.S.”

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