PRESS RELEASES (Q3/2024)
Syntra FIH Cohort #3 Pilot Study
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.
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
Syntra Intrasaccular OUS Pilot Study
Arissa Medical has enrolled n=10 of 15 patients for the initial FIH Pilot Study
PRESS RELEASES (2023)
First in Human
Positive feasibility study results with Syntra intrasaccular scaffold
Positive feasibility study results with Syntra intrasaccular scaffold
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
Positive feasibility study results with Syntra intrasaccular scaffold
Positive feasibility study results with Syntra intrasaccular scaffold
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.
Digital Press Release: via NeuroNews Int'l