April 9, 2009 - NMT Medical Inc. has received Pre-Market Approval (PMA) from the FDA to being commercial sales of the STARFlex cardiac septal repair implant for patients with ventricular septal defects (VSD).
STARFlex is constructed from a low profile, MP35N framework to which a knitted Dacron fabric is securely attached. The implant can be placed in the heart to close the VSD using a catheter during a minimally invasive procedure in the cath lab, providing an alternative to open-heart surgery.
Using spring coils in the framework, the STARFlex implant can be collapsed into a 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 design of the frame reportedly 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.
For information: www.nmtmedical.com.