Low profile knitted fabric gets FDA PMA
NMT Medical Inc announced that it received Pre-Market Approval (PMA) from the U.S. Food and Drug Administration (FDA) enabling commercial sale of the Company's STARFlex cardiac septal repair implant in the United States for patients with ventricular septal defects (VSD). The STARFlex implant can be placed in the heart to close the VSD using a catheter during a minimally invasive procedure, avoiding the need for the alternative treatment of open-heart surgery, which is considered a high-risk, invasive procedure.
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.
Commenting on the FDA approval, Frank Martin, NMT's President and Chief Executive Officer said, "The approval of STARFlex for VSD is welcome news for NMT and our customers, along with their patients, as we can now offer this next generation implant. STARFlex will replace our CardioSEAL implant, which had previously received FDA approval for VSD treatment. STARFlex features the addition of a unique self-centering mechanism, which accommodates easier implantation as well as the treatment of larger defects."
"It will be rewarding to provide this innovative treatment option to these VSD patients, and we are excited about its commercial introduction in the United States. STARFlex has been used in our CLOSURE Ipatent foramen ovale (PFO)/stroke and transient ischemic attack pivotal study and has been widely used in Europe for several years," Martin continued. "Over the next several weeks, we will be finalizing our plans for launching the product in the U.S. market."
VSD is an opening between the right and left ventricle in the lower chambers of the heart and is the most common type of congenital heart defect. When there is a large opening between these ventricles, a large amount of oxygen-rich (red) blood from the heart's left side is forced through the defect into the right side. It is then pumped back to the lungs, even though it has already been filtered and refreshed with oxygen.
This is inefficient, because oxygenated blood displaces blood that needs oxygen, which means the heart must pump more blood and may enlarge from the added work. In addition, high blood pressure may occur in the lungs' blood vessels. Over time, this increased pulmonary hypertension may permanently damage the blood vessel walls and could lead to heart failure.
NMT Medical Inc