PRESS RELEASES (Q1/2025)

NEWARK, CA (March 2025) – Arissa Medical, Inc., a Newark-based, privately held medical device company developing an innovative and proprietary intrasaccular device for the treatment of wide neck intracranial aneurysms announced the enrollment of their 4th cohort of patients in the company’s Syntra Pilot 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. The 4th cohort of enrolled patients were successfully treated at Instituto de Neurosurigia Alfonso Asenjo in Santiago, Chile by Dr. Juan Gabriel Sordo – INR Principal Investigator. 

The Syntra Intrasaccular Device is a novel US FDA Breakthrough Designation candidate that offers the ability to navigate/negotiate tortuous vasculature (e. g. ophthalmic ICA) presenting challenging acute angulated cerebral aneurysms that may otherwise require a parent-vessel treatment solution requiring DAPT (dual anti-platelet therapy). The Syntra intrasaccular endoskeleton polyhedron provides the ability to effectively reduce the wide neck diameter while providing 3-dimensional scaffold structural support for ruptured and unruptured intracranial aneurysms. Syntra offers the user/operator the reassurance and confidence that subsequent filling and finishing coils are stable within the aneurysm sac without concern for coil herniation. This provides the stability to maximize coil packing density to achieve optimal intracranial aneurysm obliteration without changing the catheterization lab’s typical embolization procedural “work-flow”.

These characteristics associated with ease-of-use, sizing metrics similar to coiling, efficient learning-curve, as well as providing a soft/flexible implant delivery platform, Syntra Origami Intrasaccular Device offers a versatile wide neck and/or irregular (complex, non-saccular) intracranial aneurysm treatment solution to the user/operator. The safety and effectiveness of the device will need to be fully examined, but the results from these series of cohorts are very promising. 

NEWARK, CA (July 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 the third enrollment of patients into its Syntra study—an early feasibility pilot study evaluating the safety and efficacy of the company’s Syntra device for the treatment of irregular, wide-necked sidewall and wide-necked bifurcation cerebral aneurysms. 

Third-cohort cases in the study were successfully performed at Instituto de Neurocirugía Dr Alfonso Asenjo in Santiago, Chile by interventional neuroradiology (INR) principal investigator Juan Gabriel Sordo.

According to an Arissa press release, Gary Duckwiler (University of California Los Angeles [UCLA] Medical Center, Los Angeles, USA) and Luis Augusto Lemme (Buenos Aires, Argentina)—who were involved in preclinical evaluations and were present for the first clinical cases—have confirmed the ease of use and ability to deliver, retrieve and redeploy the device into aneurysms with acute take-offs from the parent vessel. The release adds that the Syntra device has been able to control these wide-necked aneurysms and prevent subsequent herniation of coils into the parent artery, which is “a major issue with these difficult aneurysms”. There have been no technical failures and patients are doing well clinically, Duckwiler and Lemme further noted.

The Syntra device is a novel, adjunctive ‘framing’ scaffold endoskeleton structure designed to facilitate enhanced intrasaccular neck coverage, reducing wide-necked diameter and enabling stable adjunctive coiling to achieve optimal packing density and volume for intrasaccular blood flow-attenuated embolization treatment in cerebral unruptured and ruptured aneurysm cases. Arissa claims that, because Syntra is a purely intrasaccular device, the use of dual antiplatelet medication alongside it is not necessary.

The company’s recent release also states that, while bare platinum coils “remain as the gold standard for intracranial aneurysm treatment”, its hope is that the Syntra device can “change the way operators treat aneurysms as part of a new adjunctive standard of care”—providing them with an alternative technology through which they can achieve improved results in the treatment of difficult, wide-necked cerebral aneurysms. 

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

https://neuronewsinternational.com/arissa-medical-third-cohort-first-in-human-syntra-pilot-study/

Arissa Medical has enrolled n=10 of 15 patients for the initial FIH Pilot Study