J. J. Scutti PE, C. A. Devellian, NMT Medical, Inc., Boston, MA
Noninvasive interventional catheterization techniques are commonly used to close congenital defects (holes) within the heart. Such defects are typically repaired to correct the hemodynamic function of the heart. Recently, closure of a common defect within the heart called a patent foramen ovale (PFO) has been studied as a treatment in certain stroke and migraine patients, potentially expanding the patient population that could benefit, to be comparable to that of coronary stents. Currently available septal repair devices are fabricated from metallic frameworks combined with polymeric tissue scaffolds designed to promote healing and endothelialization. A new septal repair implant, called the BioSTAR®, incorporates a bioabsorbable collagen matrix to facilitate rapid defect closure and endothelialization. The design, materials, biocompatibility, immune response, and clinical results of the BioSTAR will be reviewed.
Summary: The application of an important emerging materials technology will be presented in this paper. The technology platform is a noninvasively implantable bioabsorbable device used to close a hole in the heart. The implant's innovative materials of construction, including the bioabsorbable collagen matrix material, will be explored, as well as the healing response and performance of the device in animal studies and human clinical trials.
