Stentrievers

Weaknesses:

Must pass through clot -> potential to fragment

Must drag clot -> potential to fragment

Multiple attempts required to extract clot (Range 1 - 6) ^5-7

Pain/Vessel wall damage from metal scraping

Low First Pass complete revascularisation (30%) ⁹

Need to bailout to alternative devices (24% of cases)⁸

Aspiration Catheter

Weaknesses:

Must drag clot -> potential to fragment

Multiple attempts required to extract clot (Range 1 - 6) ^5-7

Low First Pass complete revascularisation (30%)⁹

Need to bailout to alternative devices (33% of cases)⁸

CLINICAL RESULTS USING TODAY’S TECHNOLOGY

While outcomes for stroke patients have improved significantly over the past five years, currently more than 50% of patients treated today achieve a less than optimal outcome.^3,10

Time is Brain

WHY DO PATIENTS ACHIEVE POOR OUTCOMES TODAY?

Physicians cannot access the blocked vessel with a device diameter large enough to completely retrieve the clot.

Today, technology forces the physician to drag the clot from the brain, causing the clot to fragment, which can migrate to other locations inducing new vessel occlusion and ischemia.

Multiple passes (average number of passes, 2: range 1-6) and excessive time are required. Additional manoeuvres cause additional vessel trauma and ischemia.

WHAT IS THE FIRST PASS EFFECT

Achieving complete reperfusion on the first device pass is known as the First Pass Effect (FPE).

Achieving FPE results in a 1.8x increase in the likelihood of a good outcome after stroke. ¹¹

Today FPE is achieved in less than 30% of cases. ¹¹

We define the Unmet Clinical Need as a simple, repeatable way to completely reperfuse an occluded brain blood vessel in a single attempt.

Our Solution

Proportions of Patients with Good Outcomes

References

(3) Nogueira et al. Thrombectomy 6 to 24 Hours after Stroke with a Mismatch between Deficit and Infarct. N. Engl. J. Med. 2016

(4) Goyal et al. Endovascular Thrombectomy after Large-Vessel Ischaemic Stroke: A Meta-Analysis of Individual Patient Data from Five Randomised Trials. The Lancet 2016

(5) Tonetti et al. Successful Reperfusion, Rather than Number of Passes, Predicts Clinical Outcome after Mechanical Thrombectomy. J. NeuroInterventional Surg. 2020

(6) García-Tornel et al. When to Stop: Detrimental Effect of Device Passes in Acute Ischemic Stroke Secondary to Large Vessel Occlusion. Stroke 2019

(7) Duffy et al. Per-Pass Analysis of Thrombus Composition in Patients with Acute Ischemic Stroke Undergoing Mechanical Thrombectomy. Stroke 2019

(8) Lapergue et al. The ASTER Randomized Clinical Trial.. JAMA 2017

(9) Ducroux et al. First Pass Effect with Contact Aspiration and Stent Retrievers in the Aspiration versus Stent Retriever (ASTER) Trial. J. Neurointerventional Surg. 2020

(10) Albers etal.. Thrombectomy for Stroke at 6 to 16 Hours with Selection by Perfusion Imaging. N. Engl. J. Med. 2018

(11) Zaidat et al. First Pass Effect - A New Measure for Stroke Thrombectomy Devices. Stroke 2018

Unmet Clinical Need