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Published on: September 9, 2011
Novel Embolic Protection Device: a Feasibility Study
Elon Reshef1, Doron Bushi1, Udi Nussinovitch2,3,4
1InVatin Technologies, Ltd., Katzrin, Israel.
Insights
A novel device reroutes emboli in the aortic arch, offering a new stroke prevention method for high-risk patients. This endovascular approach avoids the bleeding risks associated with anticoagulant therapies.
Area of Science:
- Biomedical Engineering
- Cardiovascular Research
- Neurology
Background:
- Stroke is a leading global cause of death, with ischemic stroke often caused by cardiac emboli in patients with conditions like atrial fibrillation.
- Current treatments, primarily anticoagulants, carry risks of severe bleeding, necessitating alternative stroke prevention strategies.
- There is a critical need for device-based interventions for continuous stroke prevention in high-risk populations.
Purpose of the Study:
- To develop and evaluate a novel endovascular device for continuous stroke prevention.
- To assess the feasibility of an implantable device in the aortic arch to reroute emboli away from cerebral arteries.
- To provide an alternative stroke prevention method for patients with contraindications to anticoagulation.
Main Methods:
- Design of a novel endovascular tubular mesh device intended for implantation in the aortic arch.
- In vitro testing to evaluate the device's performance in preventing ischemic stroke.
- Simulation of cerebral perfusion pressures and assessment of embolic particle diversion efficacy.
Main Results:
- The endovascular device did not negatively impact simulated cerebral perfusion pressures.
- The device demonstrated efficient diversion of clinically relevant embolic particles away from cerebral circulation.
- Feasibility of the device for rerouting cardio-emboli was confirmed in vitro.
Conclusions:
- The novel endovascular tubular mesh device shows promise as a new approach for stroke prevention.
- This device offers a potential alternative to anticoagulation for high-risk patients, particularly those with contraindications.
- Further investigation into this device-based strategy could significantly impact ischemic stroke prevention.
Abstract:
Stroke is ranked as the second leading cause of death worldwide. Ischemic stroke commonly results from emboli that originate in the heart among high-risk patients, such as those who develop atrial fibrillation. Yet, treatment is currently limited to anticoagulants, which may be associated with life-threatening bleeding. Our aim was to develop an alternative, device-based approach for continuous stroke prevention in high-risk patients. To this end, a novel endovascular tubular mesh was designed to be implanted in the aortic arch and to reroute emboli away from critical cerebral arteries. The feasibility of this approach as a means of ischemic stroke prevention was tested in vitro. The simulated cerebral perfusion pressures were not affected by the device. Also, the device efficiently diverted clinically meaningful embolic particles away from the cerebral circulation. It is proposed that this device could be used to reroute cardio-emboli away from intracranial vessels as a means of stroke prevention among patients for which anticoagulants are contraindicated.
