EU approves drug delivery technology studies
initiate studies designed to evaluate its new closure technology.
The collagen matrix used in the technology has the potential to
deliver and localise drugs and other materials that may further
enhance PFO closure outcomes.
The BioSTAR PFO (Patent Foramen Ovale) closure technology will become part of an NMT-sponsored study, named BEST (BioSTAR Evaluation Study), which will be the first in-human use of a bioresorbable collagen matrix incorporated on the STARFlex platform.
The goal of the multi-centre study is to secure European commercial approval for its novel BioSTAR technology through the CE Mark process.
The BioSTAR technology potentially offers a more rapid and complete sealing of atrial level heart defects such as PFO. 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.
Patent foramen ovale, or PFO, results from an incomplete closure of the atrial septum. This type of defect is transient, meaning it is present only under certain conditions. Typically, this defect works like a flap valve, and opens up when the patient creates more pressure inside their chest.
This is called a Valsalva manoeuvre, and can occur when people cough, sneeze, or strain at stool. If the pressure is enough to open the defect, blood can flow from the right atrium to left atrium. If there is debris present in the blood that is at the site of the defect or crosses it, this can lodge in the brain causing a stroke, or in the heart causing a heart attack.
In patients for whom the patent foramen ovale has been demonstrated to open, the current standard of care is blood thinners. Drugs, such as Coumadin (Warfarin), Aspirin or Plavix, thin out the blood or keep it from sticking together and hopefully reduce the risk of a clot returning to the right atrium from the venous circulation.
"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 minimising protein deposition that could lead to thrombus formation, a potential drawback to all current PFO closure implants," said John Ahern, NMT's president and chief executive officer.
"The collagen matrix used in BioSTAR has the potential to deliver and localise genes, cells and other materials as well as drugs that may further enhance PFO closure outcomes," he added.
