NMT Medical, Inc received FDA Pre-Market Approval for the company’s ventricular septal defect (VSD) closure device called STARFlex®. The device, a percutaneously delivered double umbrella, has already been extensively used in Europe.
About the device from the product page:
STARFlex® is constructed from a low profile, MP35N framework to which a knitted Dacron® fabric 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.
Press release: NMT Medical Receives PMA Approval for STARFlex(R) as a Ventricular Septal Defect Repair Implant…
Product page: STARFlex …