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Stroke Prevention: The Newest Frontier in Interventional Cardiology

This article was originally published in Start Up

Executive Summary

The neurology community has amassed a great deal of evidence that a certain type of heart defect known as a PFO is associated with an increased risk of stroke. This finding has prompted companies with transcatheter devices developed for a niche pediatric congenital defect market to migrate to adult stroke prevention. In the new field, the risk isn't so much technical--a history of device use in the pediatric market has obviated alot of this risk--as clinical. In stroke prevention, clinical trials not only have to prove a negative, which is always difficult, but will also have to confirm the role of PFOs in stroke, as yet scientifically unproven, at the same time as they validate devices.

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Coherex Medical Inc.

These are tough times for companies developing PFO closure devices. Various energy-based approaches have hit the rocks, and clinical trial enrollment difficulties have derailed others. Coherex Medical hopes for better results with technology that it describes as safe, user-friendly, and more effective than competing technologies. The company's FlatStent PFO closure system combines a self-expanding stent with tissue growth materials, and a design that provides multiple means to close the PFO and thus boost the chances for long-term success.

Neuro Device Start-Ups Continue to Cause Headaches

Hopes have long been high for device innovations to treat a variety of neurological conditions ranging from stroke to migraines to depression. For all the promise these therapeutic areas hold, however, neurological device applications have proven to be among the most inscrutable for entrepreneurs and investors, replete with technological and clinical challenges. Several recent announcements have done nothing but confirm how challenging the neuro space is.

Cierra Inc.

Following on the pioneering work of NMT Medical and AGA Medical, Cierra has come onto the scene with a completely new way to close the PFO (a congenital opening in the heart that can cause stroke and migraine). Diverging from the implant developers that came before, Cierra has a device-based approach for migraine that leaves nothing behind in the body.

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