Initial clinical experience with a novel mechanical thrombectomy device-the ThrombX retriever

Area of Science:

• Neurology
• Interventional Neuroradiology
• Medical Devices

Background:

• Acute ischemic stroke due to large artery occlusion requires rapid reperfusion.
• Mechanical thrombectomy is a key treatment for restoring blood flow.
• Novel devices aim to improve thrombectomy safety and efficacy.

Purpose of the Study:

• To assess the safety and performance of the ThrombX Retriever, a new mechanical thrombectomy device.
• To evaluate the device's ability to axially hold thrombus using adjustable mesh segments.
• To analyze outcomes in patients with acute ischemic stroke and large artery occlusion.

Main Methods:

• A prospective, single-arm, multi-center study in 5 European centers.
• Inclusion criteria: symptomatic large-artery occlusion (Internal Carotid Artery or MCA M1 segment).
• Primary outcome: modified Treatment in Cerebral Infarction (mTICI) score post-procedure (up to 3 passes). Secondary outcomes: mTICI after one pass and 90-day functional independence (mRS ≤ 2).

Main Results:

• 30 patients treated (mean age 72, NIHSS 15.5).
• 93% achieved mTICI 2b-3 within 3 passes; 80% achieved this on the first pass.
• 100% achieved mTICI 2b-3 post-intervention; 73% achieved functional independence at 90 days. No device-related serious adverse events.

Conclusions:

• The ThrombX Retriever demonstrates safety and high rates of substantial reperfusion in acute ischemic stroke.
• The device shows potential for improving outcomes in large artery occlusion treatment.
• A larger prospective trial is planned to further evaluate device effectiveness.