BRISBANE, Australia & EGAN, Minn.–(BUSINESS WIRE)–Anteris Technologies Ltd (Anteris or the Company) (ASX: AVR), a structural heart company developing DurAVR™, the world’s only balloon-expandable, 3D single-piece native shaped aortic valve, announced today the presentation of clinical data from its first-in-human (FIH) trial for DurAVR™at the annual meeting of the Transcatheter Cardiovascular Therapeutics (TCT) medical conference to be held in Boston September 16-19, 2022.
The FIH study commenced in November 2021 and thus far, has treated 13 patients with symptomatically severe aortic stenosis (AS). The study will continue to enroll patients through 2022 and details of FIH can be found at ClinicalTrials.gov (Identifier: NCT05182307). The primary and key secondary endpoints of this trial include device feasibility assessments such as success of implantation at the anatomically accurate position, and hemodynamic performance assessments including effective orifice area (EOA), mean gradient, aortic regurgitation, paravalvular leak (PVL) and Doppler Velocity Index (DVI). Patient outcomes such as stroke, myocardial infarction, life-threatening bleeds, and all-cause mortality are to be reported at 30 days and 1-year post implantation.
“DurAVR™ represents a transformational product, and we are excited to showcase its first clinical study at one of the most prestigious interventional cardiology congresses,” commented Dr. Chris Meduri, Chief Medical officer of Anteris and a practicing interventional cardiologist at the Karolinska University Hospital, Stockholm. “We have previously demonstrated that all Anteris tissue (including the FDA approved product CardioCel®) made from our patented ADAPT® technology, have zero-DNA, zero-glutaraldehyde and are hence ultradurable in the long-term because they remain calcification- free in 10-year longitudinal follow-ups. This will allow DurAVR™to be a true lifetime treatment for patients with AS. The FIH data produced to date now demonstrate the immediate hemodynamic benefits of Anteris’ 3D single-piece native shaped aortic valve delivering a larger EOA, excellent laminar flow, and improved exercise capacity. By combining immediate and long-term benefits, DurAVR™is perfectly suited for today’s younger, more active patients,” commented Wayne Paterson, Chief Executive Officer of Anteris Technologies.
Anteris events at the TCT 2022 conference include:
1. DurAVR™ – Design Concept and FIH Results
- Presenter: Dr. Vinayak N. Bapat, Minneapolis Heart Institute, Abbott Northwestern Hospital
- Session Name: TCT Innovation: TAVR Technologies and Ancillary Devices
- Session Date: Sept 18, 2022
- Presentation Time: 11:44AM ET
- Session Time: 11:30AM-12:00PM ET
- Room: Boston Convention and Exhibition Center | Level 2 | Innovation Theater, Room 210
2. Anteris Tech’s DurAVR™ THV: Novel Leaflet Design and its Impact on Physiology & Clinical Performance
- Session Chairs: Dr. Samir Kapadia–Chair of Cardiovascular Medicine, Cleveland Clinic and Dr. Anita Asgar- Director of the TAVR Research at the Institut Cardiologie de Montreal
- Presenters: Dr Van Miegham- Erasmus University, Rotterdam, Netherlands, Dr. Paul Sorajja – Director, Center of Valve and Structural Heart Disease, Minneapolis Heart Institute, Dr. Joao Cavalcante Minneapolis Heart Institute, Dr. Chris Meduri-CMO and Karolinska University Hospital, Stockholm, Sweden
- Session Date: Sept 18, 2022
- Session Time: 3:30-4:30PM ET
- Room: Boston Convention and Exhibition Center | Exhibition Level | Presentation Theater 1, Room 052
In conjunction with its clinical presentations at TCT on Sunday September 18, 2022, the Company will host an investor conference call/KOL forum to discuss the presented FIH data on Monday Sept 19, 2022 at 8AM ET. Participating doctors will include TAVR experts that performed the first-in-human implantations, Drs. Chris Meduri, Vinayak Bapat and Susheel Kodali-Director of the Structural Heart & Valve Center at NewYork-Presbyterian/Columbia University Medical Center.
The conference call can be accessed by dialing into 1 (888) 415-4305 (US Toll-free) or 1 (646) 960-0336
(International Participants) with Conference ID 2402570
or by live webcast link
About Anteris Technologies Ltd (ASX: AVR)
Anteris Technologies Ltd is a structural heart company that delivers clinically superior and durable solutions through better science and better design. Its focus is developing next-generation technologies that help healthcare professionals reproduce consistent life-changing outcomes for patients. Anteris’ DurAVR™ 3D single-piece native shaped valve replacement addresses the needs of tomorrow’s younger aortic stenosis patients by delivering superior performance with the promise of durability through innovations designed to last the remainder of a patient’s lifetime. The proven benefits of its patented ADAPT® tissue technology, paired with the unique single piece native valve shape of our DurAVR™ valve, have the potential to deliver a game-changing treatment to aortic stenosis patients worldwide and provide a much-needed solution to the challenges facing doctors today.
This announcement was authorized by Mr. Wayne Paterson, Chief Executive Officer.
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