FDA clears PMA for NMT Medical

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NMT Medical, a developer and marketer of implant technologies for interventional cardiology, has received pre-market approval (PMA) from the FDA, enabling the commercial sale of its STARFlex cardiac septal repair implant in the U.S. for patients with ventricular septal defects (VSDs).

The STARFlex implant can be placed in the heart to close VSDs using a catheter during a minimally invasive procedure, avoiding the need for the alternative treatment of open-heart surgery, according to the Boston-based NMT.

The new implant. STARFlex will replace its CardioSEAL implant, which had previously received FDA approval for VSD treatment. STARFlex features the addition of a self-centering mechanism, according to Frank Martin, NMT's President and CEO.

"STARFlex has been used in our closure patent foramen ovale stroke and transient ischemic attack pivotal study and has been widely used in Europe for several years," Martin said. "Over the next several weeks, we will be finalizing our plans for launching the product in the U.S. market."