Technology | March 03, 2014

FDA Clears Admedus's CardioCel

Ademedus CardioCel Stem Cell Therapy

March 3, 2014 — The U.S. Food and Drug Administration (FDA) cleared Admedus’s CardioCel, a tissue product to repair and treat a range of cardiovascular and vascular defects. The company is looking to complement its existing product launch in Europe with preparation for initial sales in the United States.

The intended use of CardioCel in the United States is in pericardial closure and for the repair of cardiac and vascular defects in both adults and paediatrics.

Admedus can sell CardioCel in both Europe and the US and will pursue market approvals in Asia and other jurisdictions.

CardioCel is engineered by the group’s ADAPT tissue engineering process. It intends to be a durable, pure collagen scaffold that avoids calcification, supports native cell infiltration, growth and differentiation and which promotes a regenerative healing process.

CardioCel has shown that it does not calcify and can facilitate autologous tissue regeneration once surgically implanted, while retaining strength and natural elasticity. CardioCel is a ready to use, off the shelf product that has the potential to prevent follow up surgeries for patients because of its anti-calcification and regenerative properties.

For more information: 

Related Content

Secant Introduces First Synthetic Regenerative Cardiovascular Graft for CABG
News | Stem Cell Therapies | January 17, 2018
Secant Group, in partnership with its sister company SanaVita Medical, announced new technology to advance...
News | Stem Cell Therapies | October 24, 2017
October 24, 2017 — Roche and Ncardia have reached a broad licensing agreement whereby Roche and its affiliate compani
BioCardia Announces 12-Month Results from TRIDENT Trial of Stem Cell Delivery System
News | Stem Cell Therapies | September 26, 2017
BioCardia Inc. recently announced 12-month results from the Phase II TRIDENT clinical trial, conducted by the...
New Jersey Researcher Exploring New Stem Cell Therapies for Heart Attacks
News | Stem Cell Therapies | August 04, 2017
In petri dishes in her campus laboratory at New Jersey Institute of Technology, Alice Lee is developing colonies of...

An example of porcine cartdiac stem cells. Photo from the University of Miami Miller School of Medicine.


News | Stem Cell Therapies | June 12, 2017
June 12, 2017 — Heart muscle is one of the least renewable tissues in the body, which is one of the reasons that hear
Stem Cell Therapy Holds Promise for Treating Most Severe Cases of Angina
News | Stem Cell Therapies | May 12, 2017
An analysis of data from the entire development program consisting of three trials assessing the feasibility of using a...
3-D Printed Patch Can Help Mend a ‘Broken’ Heart

This photo shows the 3D-bioprinted cell patch in comparison to a mouse heart. When the patch was placed on a live mouse following a simulated heart attack, the researchers saw significant increase in functional capacity after just four weeks. Image courtesy of Patrick O’Leary, University of Minnesota.

News | Stem Cell Therapies | April 18, 2017
April 18, 2017 — A team of biomedical engineering researchers, led by the University of Minnesota, has created a revo
Texas Heart Institute, ischemic heart failure, adult stem cell therapy, CONCERT-HF clinical trial
News | Stem Cell Therapies | February 03, 2017
Physicians and researchers at Texas Heart Institute are recruiting patients who suffer from heart failure to...
News | Stem Cell Therapies | January 09, 2017
BioCardia Inc. announced in December the issuance of United States Patent No. 9,517,199 relating to a method of...
Overlay Init