Preclinical evaluation of the ANCD thrombectomy device: safety and efficacy in a swine clot model

Sánchez, Sonia Ma García; Bailey, Lynn; Ducore, Rebecca; Andersson, Tommy; Nogueira, Raul G; Cognard, Christophe; Ribó, Marc; Villanova, Helena; Rios, Anna; Galve, Iñaki

doi:10.1136/neurintsurg-2019-015548

Cited by 6 publications

(3 citation statements)

References 14 publications

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“…In in vitro phantom and swine models of the human neurovascular anatomy, the ANA device showed better recanalization rates than SR in combination with a distal aspiration catheter or a balloon guiding catheter. 9,10 A preliminary first in human report indicated promising results in terms of safety and efficacy. 11 The SOLONDA study (Solitaire in Combination With the ANA Catheter System as Manufactured by Anaconda) aimed to assess the safety and performance of the ANA catheter system combined with a SR in acute ischemic stroke.…”

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Clinical Results of the Advanced Neurovascular Access Catheter System Combined With a Stent Retriever in Acute Ischemic Stroke (SOLONDA)

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Ribó

Zamarro

et al. 2022

Stroke

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Background: The Advanced Neurovascular Access (ANA) thrombectomy system is a novel stroke thrombectomy device comprising a self-expanding funnel designed to reduce clot fragmentation by locally restricting flow while becoming as wide as the lodging artery. Once deployed, the ANA device allows distal aspiration combined with a stent retriever to mobilize the clot into the funnel where it remains copped during extraction. We investigated the safety and efficacy of ANA catheter system. Methods: SOLONDA (Solitaire in Combination With the ANA Catheter System as Manufactured by Anaconda) was a prospective, open, single-arm, multicenter trial with blinded assessment of the primary outcome by an independent core lab. Patients with anterior circulation vessel occlusion admitted within 8 hours from symptom onset were eligible. The primary end point was successful reperfusion (modified Thrombolysis in Cerebral Infarction score 2b–3) with ≤3 passes of the ANA device in combination with stent retriever, before the use of rescue therapy in the intention to treat population. Primary predefined analysis was noninferiority as compared to the performance end point observed in HERMES (High Effective Reperfusion Using Multiple Endovascular Devices). Results: After enrollment of 74 patients, an interim analysis was conducted, and the trial Steering Committee decided to terminate recruitment due to safety and performance objectives were reached. Mean age was 71.6 (SD 8.9) years, 46.6% women and median National Institutes of Health Stroke Scale on admission 14 (interquartile range, 10–19). Successful reperfusion within 3 passes before rescue therapy was achieved in 60/72 (83.3% [95% CI, 74.7%–91.9%]) with a rate of complete reperfusion (modified Thrombolysis in Cerebral Infarction score 2c–3) of 60% (95% CI, 48.4%–71.1%; 43/72 patients). After noninferiority was confirmed ( P <0.01), the ANA device also showed superiority in the rate of successful reperfusion with ≤3 passes ( P =0.02). First-pass successful recanalization rate was 55.6% (95% CI, 44.1%–67.0%), with a first-pass complete recanalization rate of 38.9% (95% CI, 27.6%–50.1%). Rescue therapy to obtain a modified Thrombolysis in Cerebral Infarction score 2b–3 was needed in 12/72 (17%) patients. At 90 days, the rate of favorable functional outcome (modified Rankin Scale score 0–2) was 57.5% (95% CI, 46.2%–68.9%), and the rate of excellent functional outcome (modified Rankin Scale score 0–1) was 45.2% (95% CI, 33.8%–56.6%). The rate of severe adverse device related was 1.4%. Conclusions: In this clinical experience, the ANA device achieved a high rate of complete recanalization with a preliminary good safety profile and favorable 90 days clinical outcomes.

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Clinical Results of the Advanced Neurovascular Access Catheter System Combined With a Stent Retriever in Acute Ischemic Stroke (SOLONDA)

Requena

Ribó

Zamarro

et al. 2022

Stroke

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“…Most recently, a novel type of aspiration catheter has been introduced. The Anaconda advanced thrombectomy system (Biomed) is an aspiration catheter system that comprises a delivery catheter and a novel funnel-shaped aspiration catheter which can expand to fit the size of the vessel it is deployed in ( 44 ). The funnel shape is achieved by a stent mounted at and covered by the distal end of the catheter, which is deployed and can expand up to a maximum of 5 mm diameter, thus providing flow arrest for vessels of this size or smaller.…”

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confidence: 99%

Evidence-Based Updates to Thrombectomy: Targets, New Techniques, and Devices

et al. 2021

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Endovascular thrombectomy (EVT) has been validated in several randomized controlled trials in recent years for its efficacy in the treatment of acute ischemic strokes (AIS) and is now the standard of care according to international guidelines. However, in about 20% of EVT procedures, recanalization is not achieved, and over 50% of patients who undergo EVT still do not have good functional outcome. In this article, we provide an extensive review of the latest evidence and developments in the field of EVT, with particular focus on the factors that improve patient outcomes. These factors include new and adjunctive techniques such as combination of direct aspiration and stent retriever, intra-arterial urokinase or 2b/3a inhibitors, rescue stenting, as well as novel devices including balloon guide catheters and the newer generations of aspiration catheters and stent retrievers. We also examined the latest notion of using first-pass effect (FPE) as the target to achieve during EVT, which has been associated with an improved functional outcome. While the field of EVT has been rapidly evolving, further research is required in specific AIS patient populations such as those with large ischemic core, late presentation beyond 24 h, posterior circulation strokes, and with distal medium vessel occlusion or tandem lesions to better assess its efficacy and safety.

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Mechanical thrombectomy with a novel device: initial clinical experience with the ANA thrombectomy device

Hernández

Piñana

Requena

et al. 2022

Journal of Neuroradiology

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Preclinical evaluation of the ANCD thrombectomy device: safety and efficacy in a swine clot model

Cited by 6 publications

References 14 publications

Clinical Results of the Advanced Neurovascular Access Catheter System Combined With a Stent Retriever in Acute Ischemic Stroke (SOLONDA)

Clinical Results of the Advanced Neurovascular Access Catheter System Combined With a Stent Retriever in Acute Ischemic Stroke (SOLONDA)

Evidence-Based Updates to Thrombectomy: Targets, New Techniques, and Devices

Mechanical thrombectomy with a novel device: initial clinical experience with the ANA thrombectomy device

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