Solitaire FR revascularization device 4×40: safety study and effectiveness in preclinical models

Area of Science:

• Neurology
• Interventional Cardiology
• Biomedical Engineering

Background:

• Endovascular intervention with stent retrievers is beneficial for acute ischemic stroke.
• The Solitaire 2 FR 4×40 device was developed to manage longer clots and procedural challenges.

Purpose of the Study:

• To evaluate the safety and in vitro effectiveness of the Solitaire 2 FR 4×40 stent retriever.
• To compare the safety and usability of the 4×40 device with the 4×20 device.

Main Methods:

• In vitro testing of the Solitaire 2 FR 4×40 device.
• In vivo safety evaluation in a swine model at 0, 30, and 90 days.

Main Results:

• No significant differences in overall animal health, tissue injury, or hemorrhagic/thrombogenic events were observed.
• The Solitaire 2 4×40 device demonstrated comparable safety and usability to the Solitaire 2 4×20 device.
• The longer device may offer additional technical advantages in neurothrombectomy.

Conclusions:

• The Solitaire 2 FR 4×40 stent retriever is safe and effective for acute ischemic stroke treatment.
• The device shows promise for improving neurothrombectomy procedures.
• Further clinical evaluation is warranted to confirm these findings.