Meta description: Learn about the upcoming clinical trial evaluating the SOFIA Flow 88 Aspiration Catheter for large vessel occlusions in acute ischemic stroke. Key stakeholders need updates.
A groundbreaking clinical trial is set to evaluate the performance and safety of the SOFIA Flow 88 Aspiration Catheter as an intervention for acute ischemic stroke caused by large vessel occlusion. Scheduled for launch under the sponsorship of Microvention-Terumo, Inc. and Bright Research Partners, this study addresses critical needs in medical device innovation. As of October 14, 2025, recruitment has yet to commence, marking an important developmental milestone in stroke treatment technologies.
About the SOFIA Flow 88 Aspiration Catheter
The SOFIA Flow 88 Aspiration Catheter is a state-of-the-art medical device designed for use in neurovascular procedures. Its intended purpose is to restore blood flow in patients experiencing acute ischemic stroke, specifically in cases involving large vessel occlusions. Using an aspiration-based approach, the catheter seeks to support rapid and effective clot removal with minimal invasiveness.
Manufactured by Microvention-Terumo, Inc., the catheter has been developed with precision and safety in mind. Its design aims to meet stringent regulatory standards and provide clinicians with a device that offers both reliability and high performance.
Clinical Trial Details
What is the scope of the trial?
This trial, sponsored by Microvention-Terumo, Inc. with collaboration from Bright Research Partners, will focus on evaluating the efficacy and safety profile of the SOFIA Flow 88 Aspiration Catheter. Targeted at patients suffering from acute ischemic strokes due to large vessel occlusion, the study seeks to confirm the device’s intended performance in real-world clinical settings.
Who will conduct the research?
Microvention-Terumo, Inc., a leading innovator in neurovascular technologies, along with Bright Research Partners, is spearheading this investigation. Both organizations are committed to advancing evidence-based therapeutic options for stroke care.
Why is this trial significant?
Acute ischemic stroke represents a leading cause of morbidity and mortality worldwide. Timely intervention in cases of large vessel occlusion can significantly alter patient outcomes. The SOFIA Flow 88 Aspiration Catheter aims to address current unmet clinical needs by providing physicians with a next-generation tool designed for both precision and efficiency.
The study’s findings will contribute critical data to the regulatory approval process, offering insights into the device’s clinical utility and safety for widespread use.
When will recruitment begin?
As of October 14, 2025, recruitment has not yet started. Stakeholders should monitor updates on ClinicalTrials.gov for further announcements regarding enrollment.
FAQ
- What is the purpose of the SOFIA Flow 88 Catheter?
The catheter is designed to assist in the removal of blood clots in large vessel occlusion cases of acute ischemic stroke, aiming to restore blood flow effectively. - Who is sponsoring the clinical trial?
The trial is sponsored by Microvention-Terumo, Inc., with support from Bright Research Partners. - When will recruitment for the trial start?
Recruitment has not yet begun as of the latest update on October 14, 2025. - Where can I find more information about the trial?
Further details are available on the ClinicalTrials.gov website.
Conclusion
The upcoming clinical trial for the SOFIA Flow 88 Aspiration Catheter represents an important advancement in stroke care. With the potential to address significant clinical challenges associated with acute ischemic stroke, this study is one to watch for all stakeholders, including clinical, quality, and regulatory teams.
As the start of recruitment approaches, staying informed ensures professionals can align with developments in device technology and regulatory progress.
Disclaimer
This article is intended for informational purposes only and does not constitute legal or regulatory advice. Always consult with appropriate professionals for guidance specific to your circumstances.
Full Announcement
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07216170?term=medical+device