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Israeli medical-device developer of catheter-delivered intrasaccular implants for cerebral aneurysm treatment.
LuSeed Vascular is a privately held medical-device developer based in Petach Tikva, Israel. Co-founders Nitzan Hirsh and Amir Arthur lead the company as CEO and COO. Its clinical focus is neurovascular intervention, particularly minimally invasive treatment of intracranial aneurysms.
Its flagship DOME device uses a dual-layer braided nitinol mesh designed for placement inside an aneurysm through a microcatheter. LuSeed targets both bifurcation and sidewall anatomies and seeks to minimize protrusion into the parent artery. Claimed procedural and antiplatelet advantages remain company-described design goals rather than independently established comparative outcomes.
LuSeed sponsors LUMENS-1 early-feasibility studies in Europe and Canada. Its public updates report research treatments and additional study-site activity in 2026. These developments support classification as a clinical-stage device developer; routine commercial availability and U.S. FDA marketing authorization have not been established.
LuSeed is developing DOME, a permanent intrasaccular implant for cerebral aneurysm treatment. No matching FDA 510(k) clearance, De Novo grant or PMA approval was located in the completed LuSeed named-company and product searches. No routinely marketed portfolio was established. Study registration and clinical use under a research protocol do not establish commercial marketing authorization. [6][11][10][9]
The sponsor’s ClinicalTrials.gov records describe two early-feasibility studies of the LuSeed Aneurysm Embolization System for unruptured intracranial aneurysms. NCT06761365 targets 30 participants and last posted Recruiting on November 26, 2025. NCT07259018 targets 10 participants and last posted Not yet recruiting on December 9, 2025. These are dated registry statuses, not independently confirmed current enrollment; neither record has posted results. [1][2]
LuSeed subsequently reported a first Toronto study treatment in May 2026 and additional LUMENS study activity in France in October 2026. These company reports support ongoing clinical development but do not reconcile all registry statuses or establish clinical effectiveness. Claims about avoiding dual antiplatelet therapy, improved safety and shorter procedures remain manufacturer-described objectives. The named FDA recall searches found no matches. [15][14][6][12]
Latest recorded source review: 2026-10-27.
No routinely marketed product portfolio was established. DOME is presented below as an investigational device in clinical development.
The current program combines European and Canadian early-feasibility research with company-reported study-site activity. The Israel Innovation Authority records LuSeed support under R&D, manufacturing-development and startup routes in 2023, 2024 and 2025. Those entries do not establish grant amounts, revenue or commercial launch. [3][14][15]
Self-expanding, dual-layer braided nitinol mesh implant designed for microcatheter delivery into a cerebral aneurysm sac. The manufacturer targets bifurcation and sidewall anatomies and seeks to limit protrusion into the parent artery. [6][3][8][1][2]
Investigational / in developmentIn clinical development; routine commercial availability and U.S. marketing authorization have not been established.
The company reported further study enrollment and treatment at NRI Pitié-Salpêtrière, Paris, and a site-initiation visit at CHU de Besançon. The announcement does not provide independently audited enrollment totals or clinical outcomes. [14]
LuSeed reported initiation of the LUMENS study and treatment of the first patient at St. Michael’s Hospital, Toronto. This is a company-reported research milestone; the Canadian trial registry status has not been reconciled to that report. [15]
ClinicalTrials.gov records an actual study start of October 7, 2024 for NCT06761365, an early-feasibility study targeting 30 participants. The registry last posted an update on November 26, 2025; target enrollment is not actual enrollment. [1]
Accessed 10/27/2026
Last substantive review: 10/27/2026