Friday, September 29, 2023
Friday, September 29, 2023

Contact us 561.316.3330

FDA Grants NEXUS Aortic Arch Stent Graft System Breakthrough Designation

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.”

SourceEndospan
Medical Device News Magazinehttps://infomeddnews.com
Our publication is dedicated to bringing our readers the latest medical device news. We are proud to boast that our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall purpose and objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

OTHER NEWS

4SC Receives Orphan Drug Designation (ODD) for resminostat (Kinselby) in CTCL from the US FDA

Jason Loveridge, Ph.D., CEO of 4SC, commented: “Receiving orphan drug designation for resminostat provides us with a number of important benefits, most crucially 7 years’ market exclusivity in the US, a key foundation of our efforts to commercialise Kinselby.  We are currently preparing a marketing authorisation application for Kinselby in the EU, which remains on track for submission in Q1 2024.”

Abyrx Receives FDA Clearance for MONTAGE ® Settable Bone Putty for Use in Cardiothoracic Surgery

By expanding the range of FDA-cleared surgical applications for MONTAGE, this latest milestone positions Abyrx to build upon the more than 25,000 units of MONTAGE that have been used to date by surgeons in trauma, orthopedics, sports medicine, foot and ankle, and craniomaxillofacial procedures.

FDA Grants Fast Track Designation to 9MW3011

9MW3011 has been approved to clinical study by NMPA and FDA, respectively. The first person has been dosed in the clinical study in China in March, 2023.

MicuRx receives FDA Qualified Infectious Disease Product (QIDP) and Fast Track Designation for Contezolid and Contezolid acefosamil

"We are pleased to gain the QIDP and Fast Track designations for DFI as recognition that contezolid and contezolid acefosamil are novel new agents to meet an important unmet need in this common and challenging infection", stated Dr Zhengyu Yuan, Chief Executive Officer at MicuRx. 

Via Nova Therapeutics Announces FDA clearance of Investigational New Drug (IND) Application for VNT-101

"We look forward to evaluating VNT-101 in the clinic," said Don Ganem MD, Co-Founder and CEO of Via Nova Therapeutics. "This is an important step to developing a flu antiviral with a novel mechanism of action, and a milestone for Via Nova Therapeutics as we advance our first compound into the clinic."

By using this website you agree to accept Medical Device News Magazine Privacy Policy