Aura | Lasting Embolic Protection

The Problem

Transcatheter aortic valve implantation (TAVI) has emerged as an alternative treatment option for patients with severe aortic stenosis and high surgical risk. Yet, stroke remains a devastating complication confined mainly in the peri-procedural and following days after TAVI. (reference Giustino et al.)

Because TAVI is set to expand its indication to lower surgical-risk patients, stroke prophylaxis during and after TAVI becomes of paramount importance. Currently, it is estimated that between 2 to 5 percent of patients undergoing TAVI will suffer a stroke. (Seeger J et al. Eur Heart J. 2018 Dec 24. doi: 10.1093/eurheartj/ehy847)

A novel approach to stroke prevention

Percutaneous delivery and removal
Designed to protect all major arteries from emboli
Multi-day indwell
With fine mesh emboli deflector

How it Works

VeoSource’s first technology application is designed to protect the brain for a finite time following a heart procedure or TAVI. According to various key opinion leaders in the cardiovascular and neurovascular fields, protecting the brain during a few days following left heart procedures such as TAVI for instance will show a significant benefit for the patients as >80% of stroke events occurred during the first few days following the procedure. The Aura is to be deployed percutaneously via the brachial artery prior the heart intervention to deflect any potential emboli away from the brain. The Aura can be removed under sedation percutaneously.

Embolic Protection for Patients Undergoing TAVI

TAVI & Embolic Event Correlated

Cerebral emboli are associated to various degrees with heart procedures.

Embolic brain lesions may lead to potentially devastating outcomes:

Stroke
Dementia
Cognitive decline

Incidence of new brain lesions

Risk of cerebrovascular events according to time after TAVI and the risk of an age-, sex-, and risk factor–matched population

Risk of cerebrovascular events according to time after transcatheter aortic valve implantation (green line indicates patients undergoing transcatheter aortic valve implantation [TAVI]; red line displays the risk of an age-, sex-, and risk factor–matched population). AFib indicates atrial fibrillation; NOAFib, new onset atrial fibrillation; and (N)OAC, (novel) oral anticoagulants.

Adapted from S. Stortecky and S. Windecker. Circulation. 2012

Timing of stroke after TAVI

All current approved stroke prevention devices are used acutely during the TAVR procedure. No available devices are in the market to further protect patients from stroke for the “sub-acute events” between 2 and 30 days.

Providing an embolic deflection device for at least a 2-day period could change substantially the morbidity and mortality resulting from the TAVR.