NMT Medical (Boston) said it has received approvals to initiate a multi-center clinical study in the United Kingdom to evaluate its new BioSTAR PFO (patent foramen ovale) closure technology. The BioSTAR Evaluation Study (BEST) will be the first in-human use of a bioresorbable collagen matrix incorporated on the company’s STARFlex platform.
Noting that the goal of the study is to secure European commercial approval for the BioSTAR technology through the CE mark process, NMT President and CEO John Ahern termed the approval of the BEST study “another important milestone for NMT and for our clinical researchers seeking better ways to treat their PFO patients.”
Michael Mullen, MD, interventional cardiologist at Royal Brompton Hospital (London) and chief investigator for the BEST trial, said, “Based on preclinical research results, we believe that BioSTAR potentially offers a more natural, rapid and complete sealing of atrial level heart defects such as PFO.”
He said that once delivered, BioSTAR creates a bioscaffold that promotes native tissue deposition. “During that process, the collagen matrix dissolves, leaving behind natural tissue that completely covers the STARFlex alloy framework.”
The preclinical research was conducted in Germany by Christian Jux, MD, of the University of Goettingen, and Peter Wohlsein, DVM, of the Institute of Pathology in the School of Veterinary Medicine at Hannover. NMT said additional research support was provided by researchers at Johns Hopkins School of Medicine (Baltimore).
Ahern said that NMT has developed numerous research and technology collaborations over the past few years that “are now evolving into new, improved PFO closure therapies.”
He said that BioSTAR, “which combines an advanced biomaterial and our well-established STARFlex delivery platform, [is] one important outcome of that ongoing innovation process.”
According to Ahern, BioSTAR has “remarkable characteristics.” The collagen matrix, he said, “has the potential to deliver and localize drugs, genes, cells and other materials that may further enhance PFO closure outcomes.” The BioSTAR implant to be evaluated in the BEST clinical study, for example, will incorporate an ionically bound heparin substrate that elutes over time.
“We believe this feature improves device hemacompatibility by minimizing protein deposition that could lead to thrombus formation, a potential drawback to all current PFO closure implants,” Ahern said.
NMT Medical is investigating the potential connection between PFOs and brain attacks such as migraine headaches, stroke and transient ischemic attacks (TIAs). More than 16,000 PFOs have been closed worldwide with NMT’s technology.