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Admedus receives European CE Mark for CardioCel 3D® and VascuCel®

CE marking is a certification mark that indicates conformity with European health, safety, and environmental protection standards.
surgeon holding CardioCel 3D® heart product
The first phase of the commercial launch of CardioCel 3D® in Europe begins later this month

Admedus Ltd (ASX:AHZ) has received regulatory approval in the form of the CE Mark for its CardioCel® 3D product portfolio and its collagen bioscaffold VascuCel® in Europe.

Regulatory approval is an important step forward as the company continues to increase global sales.

Admedus intends to commence the first phase of its commercial launch of CardioCel 3D® later this month, initially working with selected key opinion leaders familiar with the technology.

Professor Tomasz Mroczek of Poland said: “After our initial positive experience with ADAPT® we are excited to have the choice of these 3D shaped products that will produce better reconstructions for complex aortic arch repair surgeries.

READ: Admedus delivers $25.6 million in total group revenue for the 2018 financial year

Admedus’s CEO Wayne Paterson said: “Obtaining CE Mark approval for the 3D portfolio is a further endorsement of the medical need and effectiveness of our 3D shaped collagen bioscaffold; a world first technology with proven anticalcification properties and zero DNA.

“Today’s approval of the 3D portfolio in Europe further reinforces the company’s focus on global strategic growth with geographic expansion into key markets and portfolio expansion of ADAPT® tissue technology products.”

Admedus’s ADAPT® products are sold globally under the product names CardioCel®, CardioCel Neo®, CardioCel 3D®, and VascuCel®.

Proven and peer-reviewed clinical benefits

The ADAPT® tissue technology portfolio has published scientifically proven and peer-reviewed clinical benefits leading to better outcomes for patients, surgeons and savings to overall healthcare expenditure.

Paterson added: “The 3D single piece aortic valve is unique in the industry and forms the backbone of the company’s TAVR developmental project which has been expedited.

“We have now confirmed that human clinical trials will commence earlier than planned, and the development project has already generated great interest within the global medical community as the ADAPT® portfolio of products expand from mainly paediatric use to a wider patient population in the future.”

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