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STARFlex^® Overview

STARFlex^® septal repair implant is constructed from a low profile, MP35N framework to which surgical polyester mesh matrix is securely attached. STARFlex^® is comprised of two umbrella shaped discs one for each side of the septum. Both the framework and fabric are made from the most biocompatible materials known for this application. The framework in particular has been selected for its excellent biocompatibility, compliance and profile. After all, this implant will be in place for the life of the patient.

Using spring coils in the framework, the STARFlex^® implant can be collapsed into a very small tube (catheter) for insertion into the heart. Once inserted through the catheter, the STARFlex^® implant is opened, with one umbrella positioned on each side of the defect. The spring coil design gives STARFlex^® three unique features:

• It holds the STARFlex^® septal repair implant securely in place at the site of the defect.
• The unique design of the frame allows the device to conform to variations in the anatomy of the septum, keeping a low profile without obstructing the flow of blood through the atria.
•  STARFlex^® adds a flexible, self centering system to the CardioSEAL^® implant. STARFlex^® is designed to make the implant more effective in sealing the defect and speeding up the healing process. It is implanted in the identical way as prior generations.

Once in position, the STARFlex^® septal repair implant is released from the catheter, and tissue grows into and around the fabric and metal framework.

Procedures using NMT’s STARFlex^® septal repair implants are less invasive and less costly than open-heart surgery. The procedure is performed by an interventional cardiologist in the catheterization laboratory and typically lasts less than one hour. The patient is usually allowed to return home the same day or the following morning. Since surgery is not involved, the patient is able to get back to an active lifestyle in just a short time following the procedure.

The STARFlex^® septal repair implant may offer an alternative to the traditional treatment of continuous drug therapy and the lifestyle restrictions that this may impose.

 Please contact NMT Medical, Inc. for questions regarding specific geographic areas.

In the United States, STARFlex^® is FDA approved for VSD closure.  STARFlex^® has received CE Mark and is commercially available in Europe.

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