Microvention, a wholly owned subsidiary of Terumo Corporation, has today announced the publication of data from SOFAST—a prospective, multicentre US study assessing the efficacy and safety of the 6Fr Sofia flow plus aspiration catheter as a first-line endovascular stroke thrombectomy technique. Findings from the study have been published in the Journal of NeuroInterventional Surgery (JNIS).
The SOFAST study assessed the Sofia flow plus aspiration catheter in the treatment of acute ischaemic stroke caused by large vessel occlusion. It involved 108 patients, and aimed to confirm the catheter’s safety, speed and effectiveness in revascularisation.
As per a Microvention press release, the “long-standing legacy of Sofia” is reinforced by several datapoints observed in this publication—including the following:
- Speed: 12-minute median groin puncture to clot contact time and 17-minute median groin puncture to recanalisation time
- Efficacy: 75% first-pass modified thrombolysis in cerebral infarction (mTICI) ≥2b using Sofia 6Fr
- Safety: 0% embolisation to new territories (ENT) and symptomatic intracranial haemorrhage (ICH) rate within 24 hours
- Clinical outcomes: 66.7% of patients experienced good functional outcomes at 90 days
“The efficacy and safety data from this prospective, multicentre, independent core lab-adjudicated SOFAST study are very impressive and set a new innovation standard,” said Dheeraj Gandhi (University of Maryland School of Medicine, Baltimore, USA). “High rates of mTICI ≥2b [97.2%] revascularisation at the procedure end, 70.4% rate of mTICI 2c or better after the first pass, median time to recanalisation of 17 minutes, and 66.7% rate of good clinical outcomes, are amongst the very best metrics reported with contemporary thrombectomy devices.”
“The SOFAST study further underscores that our Sofia aspiration catheters have set the standard for more than a decade with its renowned trackability, speed and, now, with further proven clinical performance,” added Carsten Schroeder, president and chief executive officer, Microvention. “We will continue to participate in critical clinical research such as SOFAST, work side-by-side with leading physicians around the world to identify the evolving needs in patient care, and then transform those insights into innovative technologies that help to save patient lives.”
Microvention also recently celebrated a decade of legacy innovation commemorating the anniversary of Sofia and Sofia flow plus aspiration catheters, with more than half a million worldwide procedures performed across 170 countries, and more than 30 articles published globally since it was first introduced over 10 years ago.