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CorMatrix Gets FDA Nod For Heart Valve Study

Tuesday, March 3, 2015 5:14:00 AM PDT | VentureDeal
   Roswell, Georgia  --  CorMatrix Cardiovascular said that it has received FDA approval for an Investigational Device Exemption (IDE).

The company will now be able to institute an early feasibility study of its CorMatrix ECM Tricuspid Heart Valve.

The purpose of the trial will be to evaluate the proof of principle and initial clinical safety for up to 15 subjects at five separate US centers.

The technology will provide replacement of the tricuspid valve with the company's valve in patients with tricuspid valve disease that is not amenable to annuloplasty or other repair.

CorMatrix says that it to valve has a unique 3-D scaffold characteristics that enables it to remodel itself over time into a fully functional heart valve and should not represent a long-term "foreign body".

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