NMT Medical Receives CE Mark Approval For BioSTAR
Boston, MA - NMT Medical, Inc. announced recently that it has received CE Mark approval in Europe for its BioSTAR bioabsorbable septal repair implant technology and Rapid Transport delivery system. The CE Mark is required in order to commercialize a product in the European Union and other select countries.
NMT's President and Chief Executive Officer John E. Ahern said, "Receiving CE Mark approval for BioSTAR in Europe is an important achievement for NMT and we are enthusiastic about the potential impact of our bioabsorbable implants. BioSTAR also recently received Canadian regulatory approval and we anticipate initiating a market launch for BioSTAR in both Europe and Canada early in the third quarter. Our first priority will be to accommodate the doctors currently using our STARFlex implant, as well as their patients, who have been eagerly awaiting the BioSTAR launch. In addition, BioSTAR has been approved for use in MIST II, our pivotal patent foramen ovale (PFO)/migraine trial in the U.S."
BioSTAR is designed to provide biological closure of atrial level defects using the patient's natural healing response. Data has shown that 90 to 95% of the implant is absorbed over time and replaced with healthy native tissue. The clinical data from the prospective multi-center BEST (BioSTAR Evaluation STudy) trial, published in the October 2006 edition of the peer-reviewed journal Circulation, demonstrated that BioSTAR provides a more rapid and complete closure of atrial septal defects, with a 92% closure rate at 30 days and 96% at six months.
"BioSTAR represents the first implant in a new generation of bioabsorbable technologies that NMT is developing in order to improve the treatment of structural heart disease," said Ahern. "As demonstrated by the BEST clinical trial, we believe the unique biomaterial, drug and device combination used in BioSTAR enhances positive septal closure outcomes.
We currently believe that receiving the CE Mark further underscores the advanced design and proven effectiveness of BioSTAR. We continue to remain focused on strengthening NMT's leadership position in this field by bringing to market the most innovative and technologically advanced products."
The BioSTAR bioabsorbable septal repair implant will be offered in three sizes: 23mm, 28mm and 32mm. Equipped with the latest available Rapid Transport delivery system, the average procedure time to close a septal defect with BioSTAR is approximately 40 minutes. BioSTAR incorporates a purified acellular collagen matrix delivered on the proven STARFlex alloy framework. The collagen used in BioSTAR also is a platform for timed release of biological response modifiers (genes, cells, proteins and drugs). An elutable heparin substrate has been included in the BioSTAR design and provides a means to minimize the thrombus formation that occasionally occurs in all intra-cardiac devices.
SOURCE: NMT Medical, Inc.