Data from a multicentre clinical study supporting the use of Anaconda Biomed’s Advanced Neurovascular Access (ANA) catheter system for treating ischaemic stroke have been published in the journal Stroke. The company’s mechanical thrombectomy system was shown to achieve a high rate of complete recanalisation and favourable 90-day outcomes in the SOLONDA (Solitaire in combination with the ANA catheter system manufactured by Anaconda) trial.
“The ANA system represents an exciting new treatment option in ischaemic stroke, where time is brain,” said lead author and principal investigator Alejandro Tomasello (Hospital Vall d’Hebron, Barcelona, Spain). “Achieving the highest degree of reperfusion with the minimum attempts, ideally in a single pass, has been described as a robust predictor of favourable outcome. The ANA system performed very well in this regard.”
The study in question is a 125-patient, prospective clinical trial designed to assess system safety, as well as reperfusion measured using the modified treatment in cerebral infarction (mTICI) score. According to an Anaconda press release, the steering committee decided to terminate the study after enrolment of 74 patients, at which point an interim analysis found “overwhelming evidence” confirming that safety and performance objectives were already met.
The published results are as follows:
- The primary endpoint, defined as successful reperfusion (mTICI 2b–3) within three passes before rescue therapy, was achieved in 83.3% of patients, with a complete reperfusion (mTICI 2c–3) rate of 60%.
- The ANA system showed superiority in the primary outcome analysis (p=0.02) after non-inferiority was confirmed (p<0.01).
- The rate of first-pass successful recanalisation (mTICI≥2b) was 56%, with a first-pass complete recanalisation rate of 39%.
- The rate of favourable functional outcomes (modified Rankin Scale [mRS] score 0–2) at 90 days was 57.5%, with a 90-day rate of excellent functional outcome (mRS 0–1) of 45.2%.
Anaconda’s investigational ANA catheter system consists of unique, funnel-shaped delivery and aspiration catheters to be used in combination with a stent retriever, the release details. When deployed, the funnel self-expands and directly conforms to the artery diameter up to 5mm. It is designed to locally restrict flow and allow full thrombus extraction without fragmentation. The SOLONDA study aims to validate earlier testing that achieved statistically significant improvement in revascularisation rates at both first and third pass.
“The SOLONDA multicentre study results are excellent, and consistent with early, single-centre findings that were published in the Journal of Neuroradiology in December 2020,” said Francois Salmon, CEO of Anaconda. “We look forward to the opportunity to bring the ANA system to the many physicians and patients affected by ischaemic stroke.”