Industry updates—including several revealed during this year’s Society of NeuroInterventional Surgery (SNIS) annual meeting (22–26 July, Colorado Springs, USA)—garnered much of our readers’ attention throughout July. Alongside a number of news items on the latest neurovascular catheter technologies, late-breaking clinical data on a novel liquid embolic agent and the potential for the modified Rankin scale to be re-assessed in the context of stroke studies are also prominent among NeuroNews’ top stories from the month.
1. Novel liquid embolic agent meets primary feasibility and safety endpoints in EMBO-01 trial
Arsenal Medical has announced that NeoCast—a first-of-its-kind, shear-responsive liquid embolic material designed for deep distal penetration—met its primary feasibility and safety endpoints in the open-label, multicentre, prospective EMBO-01 clinical trial. These data were presented at the 2024 SNIS annual meeting.
2. Radical presents initial data on recently US FDA-cleared catheter technology
Radical Catheter Technologies has announced 510(k) clearance by the US Food and Drug Administration (FDA) for its Radical catheter—which, the company claims in a recent press release, is “the first significant advance in catheter technology in more than three decades”.
3. Microvention announces publication of SOFAST clinical data
Microvention, a wholly owned subsidiary of Terumo Corporation, has announced the publication of data from SOFAST—a prospective, multicentre US study assessing the efficacy and safety of the 6Fr Sofia flow plus aspiration catheter as a first-line endovascular stroke thrombectomy technique. Findings from the study have been published in the Journal of NeuroInterventional Surgery (JNIS).
4. The modified Rankin scale as a stroke trial endpoint: important, but not all-encompassing
The modified Rankin scale (mRS) is something of a default clinical outcome metric in many contemporary stroke studies, but—as Eva Mistry and Paul Wechsler (both Cincinnati, USA) write in this NeuroNews guest article—represents an imperfect method for measuring success, and the time may therefore be right to re-evaluate its usage in stroke research.
5. Spryte Medical receives Breakthrough Device designation from US FDA for neuro OCT technology
Spryte Medical has announced that its neuro optical coherence tomography (nOCT) technology has been granted Breakthrough Device designation by the US FDA. This recognition underscores the “transformative potential” of nOCT in neurointervention and cerebrovascular treatment, the company claims.
6. Rapid Medical completes initial neurovascular cases in USA with Drivewire 24 following FDA clearance
Rapid Medical has announced the first procedures in the USA with the breakthrough deflectable access platform Drivewire 24, doing so at the 2024 SNIS annual meeting. This milestone follows the US FDA clearance of the device.
7. Q’Apel Medical appoints Jodie Fam as new CEO
Q’Apel Medical has announced the appointment of Jodie Fam as its new chief executive officer (CEO). With more than two decades in the medical device industry, Fam has held executive leadership positions at multiple medical device companies, including public and several venture-backed startups, as noted in a Q’Apel press release.
8. Route 92 Medical announces commercial launch of FreeClimb 88 catheter system
Route 92 Medical has announced the commercial launch of the FreeClimb 88 catheter system comprising the FreeClimb 88 catheter and the Tenzing 8 delivery catheter—all designed to work with the Base Camp sheath.
9. Data analyses reveal possible link between gastrointestinal syndromes and brain aneurysm risks
There is a potential connection between a diagnosis of certain gastrointestinal (GI) syndromes, and the formation and rupture of intracranial aneurysms, according to research presented at this year’s SNIS annual meeting.
10. Imperative announces US FDA clearance and initial cases with “first” stroke-specific insert catheters
Imperative Care has announced US FDA 510(k) clearance of its Zoom 6Fr insert catheters, as well as successful completion of the first case with these catheters at Huntsville Hospital in Huntsville, USA.
