NMT completes enrollment in study of BioSTAR implant for structural heart defects

By E. Janene Geiss

Philadelphia, Nov. 29 - NMT Medical, Inc. announced Tuesday that it completed patient enrollment in its BioSTAR Evaluation STudy (BEST) in the United Kingdom.

The multi-center study, which received regulatory approval in June, is evaluating the new bioabsorbable collagen matrix technology designed to promote biological closure of structural heart defects such as PFO (patent foramen ovale), according to a company news release.

The BioSTAR implant is delivered through a minimally invasive, catheter-based procedure.

"What is remarkable about BioSTAR is that once implanted, it seems to 'melt' onto the septal wall with little or no profile. We are seeing higher acute closure rates with this implant technology compared to what is currently available. I believe the concept of bioabsorbable devices for closing PFOs may now be a reality and represents a major milestone in patient management," Michael Mullen, interventional cardiologist at Royal Brompton Hospital in London and chief investigator for the study, said in the release.

About 60 patients were enrolled in the BEST study and will be followed for six months. The study was designed to gain European commercial approval for BioSTAR through the CE Mark process. Approval is expected by the end of 2006, officials said.

BioSTAR combines an advanced biomaterial and NMT's proven STARFlex delivery platform, officials said.

Once implanted, BioSTAR creates a bioscaffold that promotes native tissue deposition. During that biological closure process, the collagen matrix dissolves leaving behind natural tissue that completely covers the STARFlex alloy framework, officials said.

The bioabsorbable collagen matrix used in BioSTAR also has the potential to deliver and localize drugs, genes, cells and other materials that may further enhance PFO closure outcomes. The implant being evaluated in the BEST clinical study incorporates an ionically bound heparin substrate that elutes over time. This feature is designed to minimize device thrombus, a potential risk with all current intra-cardiac devices, officials said.

Officials said early results are encouraging and confirm what was observed in preclinical research.

NMT Medical, based in Boston, designs, develops and markets proprietary implant technologies that allow interventional cardiologists to treat cardiac sources of migraine headaches, stroke and other potential brain attacks through minimally invasive, catheter-based procedures.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.