Anteris Technologies Announces Presentation of First-In-Human Data for its Novel TAVR Product, DurAVR™ at the 2022 Annual TCT Congress in Boston
14 September 2022 - 8:34AM
Business Wire
Investor Conference Call and KOL Forum From
TCT 2022 Discussing DurAVR™ Clinical Data to be
Hosted on Sept 19, 2022 at 8AM ET
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
https://event.on24.com/wcc/r/3928771/05E4E4A527DE8E788445CC3EE4E99B61
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.
For more information:
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version on businesswire.com: https://www.businesswire.com/news/home/20220912005120/en/
Deanne Curry GRACosway E: investors@anteristech.com M: +61 414
388 997 Twitter: @AnterisTech Facebook:
www.facebook.com/AnterisTech LinkedIn:
https://www.linkedin.com/company/anteristech
Dejan Toracki Corporate Development Director Anteris
Technologies, Ltd. dtoracki@anteristech.com +61 409 340 641
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