PRESS RELEASES (2024)

Syntra FIH 6-mo. DSA Follow-Up

NEWARK, CA (March 2024) – Arissa Medical, Inc., a Newark-based, privately held medical device company developing an innovative and proprietary intrasaccular scaffold device for the treatment of wide neck intracranial aneurysms announcing 6-month DSA follow-up of their 1st cohort of patients in the company’s Syntra First-In-Human (FIH) study. Syntra FIH study is an early feasibility study evaluating the safety and efficacy of the company’s Syntra device for the treatment of Wide Necked Sidewall (WNSA) and Wide Necked Bifurcation (WNBA) cerebral aneurysms.

The 6-month radiographic follow-up was performed by Dr. Naoki Kaneko (MD, UCLA Interventional Neuroradiology) Independent Medical Monitor. This clinical report summary of the Syntra FIH study provides evidence of the favorable safety and efficacy profile at 6-month DSA follow-up.

The Syntra FIH study's 6-month follow-up results initially indicate that it is a safe and efficacious treatment for wide necked intracranial aneurysms. The absence of serious adverse events and successful occlusion rates align with the study's Syntra Intrasaccular Scaffold safety and effectiveness goals – results from the final 12-month DSA follow-up are still needed for assessing longer-term outcomes.

FIH Clinical Study Site

Instituto de Neurocirugia Alfonso Asenjo hospital located in Santiago, Chile via Dr. Juan Gabriel Sordo – INR Principal Investigator (PI)

Digital Press Release: via NeuroNews Int'l

https://neuronewsinternational.com/arissa-reports-initial-six-month-radiographic-follow-up-from-syntra-fih-study/

PRESS RELEASES (2023)

First in Human

NEWARK, CA (February 2024) – Arissa Medical, Inc., a Newark-based, privately held medical device company developing an innovative and proprietary intrasaccular scaffold device for the treatment of wide neck intracranial aneurysms announced the enrollment of their 2nd cohort of patients in the company’s Syntra Study. Syntra Study is an early feasibility study evaluating the safety and efficacy of the company’s Syntra device for the treatment of Wide Necked Sidewall (WNSA) and Wide Necked Bifurcation (WNBA) cerebral aneurysms. Recent cohort presented significantly tortuous vasculature and “irregular” wide neck aneurysm morphologies for evaluating safety and effectiveness of the Syntra device in challenging scenarios.

Syntra is currently limited to investigational use only

Digital Press Release: via NeuroNews Int'l

https://neuronewsinternational.com/arissa-medical-enrols-first-patients-in-first-in-human-syntra-study/

Positive feasibility study results with Syntra intrasaccular scaffold

NEWARK, CA (Q4/2023) – Arissa Medical, Inc., a privately held medical device company developing an innovative and proprietary intrasaccular device for the treatment of wide neck intracranial aneurysms announced the successful evaluation of the Syntra Intrasaccular Scaffold system under simulated use conditions under fluoroscopy using clinically relevant in-vitro intracranial aneurysm models provided by The Jacobs Institute (JI). Syntra INR User Study evaluated the performance of the company’s Syntra device for the treatment of cerebral Wide Necked Sidewall (WNSA) and Wide Necked Bifurcation Aneurysms (WNBA). These “Irregular” wide neck non-saccular aneurysms with acute angulations (defined as the unmet clinical need) were successfully treated at The Jacobs Institute in Buffalo, NY by Dr. Adnan Siddiqui and Dr. Elad Levy – INR Study Investigators.

The Syntra device is a novel intrasaccular scaffold endo-skeleton implant designed to facilitate the treatment of irregular intracranial wide neck aneurysms that pose acute angulation challenges often found in sidewall aneurysms and bifurcated aneurysms with acute take-off angles in aneurysm morphology. “Similar to coils-alone, Syntra may have advantages for irregular aneurysms allowing the user more freedom with respect to aneurysm shape and morphology. Syntra may be of great use in ruptured aneurysms where stents are not an option. INR’s are moving away from parent vessel implants requiring DAPT as new Intrasaccular Devices enter this space.”

Furthermore, as JI Study Investigator(s) explains, “Syntra may provide utility where you don’t have a standard shaped aneurysm with a wide neck and/or do not have true orthogonal bifurcation.” In addition, “Potential adjunctive-use with less coils, therefore providing cost savings, reduced risks (e. g. less devices/less risks, fluoroscopy, contrast media & overall procedural time) and provide greater security knowing that the aneurysm’s wide neck is protected is a plus for Syntra Intrasaccular Scaffold device.” The results from this JI INR User study are very promising for the Syntra adjunctive Intrasaccular Therapy (adjunctive IST) device in treating irregular wide neck intracranial aneurysms.