BioSTAR^®

Organogenesis has teamed with an advanced medical device technology company, NMT Medical, Inc., to develop implant technologies that allow interventional cardiologists to treat cardiac sources of migraine headaches, stroke and other potential brain attacks. The company is investigating the potential connection between a common heart defect called patent foramen ovale (PFO) and the aforementioned brain attacks.

A PFO is an opening between the right and left atria (upper chambers of the heart) in the fetal heart that allows for circulation to bypass the non-functioning fetal lungs. Usually during the first several months after birth, the PFO completely closes, preventing venous blood and arterial blood from mixing. In up to 25% of the population, the defect does not completely seal. This defect may allow the movement of unfiltered blood (shunting) from one atrial chamber to the other, allowing blood flow that may contain micro-emboli and other debris to travel to the brain. This may be a risk factor for stroke and severe migraine headaches in some patients.

PFOs have been associated with:

• Transient ischemic attack (a warning sign of a stroke)
• Decompression illness (found in divers)
• Embolic stroke
• Migraine headaches
• Dementia
• Cognitive decline

Ten percent of the general population suffers from migraine headaches. That means there are approximately 30 million Americans with this debilitating disorder. It is further estimated that worldwide approximately four million patients may benefit from PFO closure.

It has been said that having a PFO closed with a device results in tremendous savings in healthcare. The cost of a patient with a migraine (over a lifetime), as a result of PFO and not having it closed, surpasses the cost of having the closure performed.

Organogenesis supplies its proprietary technology, FortaFlex^® that is then incorporated into the STARflex^® device, replacing the synthetic material. The resulting product is called BioSTAR^®.

BioSTAR^® gained European and Canadian regulatory approval in 2007.

BioSTAR® PFO Implant
30 days		90 days
BioSTAR® photos provided by: Dr. Christian Jux, University of Goettingen/Germany and Dr. Peter Wohlsein, Institute of Pathology, School of Veterinary Medicine Hannover, Hannover/Germany.

STARflex^® is a registered trademark of NMT Medical.
FortaFlex^® is a registered trademark of Organogenesis Inc.
BioSTAR^® is a registered trademark of NMT Medical.