When we read the headline of this BBC report:
we were worried about more do-it-yourself surgery, this time for gunshot victims.
But instead, the BBC is ‘covering’ a new product from Organogenesis and NMT called BioStar that closes patent foramen ovales, the hole between the atria that’s used in fetal circulation. This hole should close at birth but persists in 25% of adults, sometimes problematically (leading to strokes and / or migraines). Some celebrities with PFO include Tedy Bruschi of the Patriots, and Ariel Sharon.
Currently, the PFO can be closed with graft material — but some patients end up with inflammation around the graft material. BioStar uses a biodegradable mesh that encourages “self-repair” — the body’s own cells migrate into the material, eventually replacing it:
In the womb, the opening is necessary to allow efficient circulation of blood and oxygen before the lungs start working.
After birth, the hole should close to separate the two chambers. Sometimes, however, this does not occur correctly.
…In turn, this means blood can bypass the filtering system of the lungs and if debris are present in the blood, such as small blood clots, these can travel to and lodge in the brain, causing a stroke.
Dr Michael Mullen, the consultant cardiologist who has been using the device to treat his patients, said: “Traditional grafts are permanent and so can cause an inflammatory reaction, which can lead to problems.
“Instead, this treatment does the repair job and then disappears in a natural way. The healing is very similar to how the body would heal itself normally.”
So far he has treated about 70 patients with the BioSTAR device, all who were deemed to be at high risk of stroke because of their PFO.
He said some of his patients have reported relief from their migraines since having the treatment.
The product is not available in the US but is being studied as part of the MIST II trial for PFOs and migraines.
More from Organogenesis and MIST II…
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