, Jan. 10, 2020
/PRNewswire/ -- AVVie GmbH ("Angel Valve") completed the 90 days chronic animal safety trial for the Mitral Butterfly
® device for degenerative mitral regurgitation.
® is a proprietary chordal repair technique restoring the coaptation plane of a flail leaflet in degenerative mitral regurgitation. Additionally, the unique deployment technique restores the support apparatus of the mitral valve in one step
. It is a unparalleled technique and a differentiated method from presently known repair concepts. The primary advantage of the mechanism of action containing the prolapsing segment is the introduction of an artificial papillary muscle as valvular support.
The Mitral Butterfly
® device is intended to advance chordal repair. The present chronic animal study was to demonstrate safety of the device at 90-day follow-up. There were no device related adverse effects and no deterioration of valve function during follow up. All safety endpoints were met, and structural integrity was maintained out to an average of 12 million cycles per animal.
MD, MBA, said: "The successful completion of the chronic animal study is a major step in the development of a feasible mitral repair system and an advancement of mitral innovation." Werner Mohl, MD, PhD, Founder of AVVie, added: "We are pleased to reach this important milestone in line with our ambitious development plan. We are committed to bring a safe and effective device to the clinical arena."
About AVVie GmbH ('Angel Valve')
AVVie GmbH (www.angelvalve.com), located in Vienna, Austria
, founded in 2018, is a privately held start-up and is a spin-off of the Medical University of Vienna. It provides innovative solutions for the treatment of severe mitral regurgitation, aiming to improve short and long-term clinical outcomes and reduce associated costs.
AVVie, in a first step, has developed a "Mitral Butterfly
®" transcatheter repair device, targeting degenerative mitral dysfunction (DMR). It may also provide more device options for functional mitral regurgitation (FMR), with a derivative of this device that allows annular modification with combined concepts in the pipeline.
Learn more at: www.angelvalve.com.
NOTE: The Mitral Butterfly
® System is not commercially available.
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SOURCE AVVie GmbH