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With data from the prospective SUCCESS study having demonstrated the safety and effectiveness of temporary assistance in coil-embolisation procedures aided by the Comaneci device (Rapid Medical), leading investigators Jason Davies (State University of New York, Buffalo, USA) and Ricardo Hanel (Baptist Medical Center, Jacksonville, USA) sit down with NeuroNews to discuss these results, and the wider role for temporary neck bridging in intracranial aneurysm treatments.
The treatment of wide-neck aneurysms requires operators to balance effective coil retention with the limitations and risks of adjunctive techniques—particularly in ruptured cases.
“When you have a wide-neck aneurysm, you need to keep the coils in place, ideally without a permanent implant—especially in ruptured cases, where committing a patient to upfront DAPT [dual antiplatelet therapy], as you would need to with a stent, just complicates everything downstream,” Davies explains. “The other unmet need is […] packing in the coils without flow arrest, as that can cause a number of issues in terms of thromboembolic complications and also compliance in patients who are awake during the procedure.”
As a temporary implant, Comaneci is intended to address these competing demands, providing a scaffold to support coil packing while maintaining blood flow and removing the need to commit to upfront DAPT and its associated risks. Findings from the US Food and Drug Administration (FDA) post-market SUCCESS study—first presented at the 2024 Society of NeuroInterventional Surgery (SNIS) annual meeting (22–26 July, Colorado Springs, USA)—indicate that these benefits extend beyond theory and translate directly into clinical practice.
“Excellent” clinical outcomes
Across 90 consecutive wide-neck aneurysm patients enrolled at 17 US centres, the SUCCESS investigators report immediate occlusion (Raymond-Roy I/II) in 85.6% of cases, increasing to 94.7% at six-month follow-up. Additionally, only one patient (1.1%) required retreatment.
Davies and Hanel agree that these findings speak to the quality of the coiling achieved in the study, with Comaneci-assisted procedural success ultimately reducing the likelihood of recurrence. In Hanel’s view, these “excellent” six-month data are “better than expected”, with the low retreatment rate serving as testimony that coiling “remains a viable option”.
“Even if you just look at Raymond-Roy I at day one [79%] and latest follow-up [89%], those results should be very reassuring for operators,” he adds. “This also shows how much coiling technology has improved and that a good coiling procedure—especially when you have an assistive device to allow better coil compaction—can achieve very good results.”
The study also demonstrated a minimal thromboembolic complication rate of 5.5%, with no symptomatic events. According to Davies, these figures compare very favourably to the literature on stent- and balloon-assisted coiling. He attributes this to the “biological rationale” by which blood flow is maintained during deployment of the Comaneci device.
“What that suggests is that we’re able to pack enough to really establish a condition of stasis within the aneurysm dome,” Davies adds. “You’re getting thrombosis, as opposed to compaction, over time—which is what we always hope for but is difficult to achieve with low packing density.”
The key to success?
Clinical outcomes from SUCCESS further reinforce Comaneci’s “very strong safety profile”, Davies says. Not only did modified Rankin scale (mRS) scores of 0–2 improve from 73% at baseline to 86% at six months, but ruptured aneurysm patients showed gains in mRS 0–2 from 46.8% at baseline to 73.3% at three months too. Davies calls this a “standout finding” in the setting of acute aneurysm treatment, confirming that upfront heparin administration to reduce thromboembolic risk did not lead to an uptick in adverse events.
“The part of the study that really gave me comfort was that ruptured cohort, because we didn’t see an increase in haemorrhagic complications,” he comments. “Comaneci now plays a more primary role in my ruptured cases.”
In Hanel’s view, a key strength of SUCCESS is its inclusive design. While focused on wide-neck aneurysms (neck diameter, 4–10mm; dome-to-neck ratio, <2), he and the other leading investigators kept the inclusion criteria “as broad as possible”, enrolling patients with both sidewall and bifurcation aneurysms as well as ruptured and unruptured cases alike.
And—while its single-arm design limits direct comparison with other techniques—both Davies and Hanel highlight the value held by SUCCESS, with the latter noting that Comaneci-assisted coiling appears to be “as safe as balloon-assisted coiling, and safer than stent-assisted coiling”, based on existing literature.
“These results are robust in that we had independently reviewed core-lab analysis and adjudication from a DSMB [data safety monitoring board], which reassures us that the results are genuine,” Davies adds.
Real-world implications
For Davies, the significance of these findings ultimately lies in their practical impact on one of the most challenging areas in neurointervention.
As a firsthand user of Comaneci, he notes how well the device conforms to the neck of an aneurysm, contributing to the packing density that can be achieved. Another noteworthy trait is that it facilitates having one or multiple backup plans—in any endovascular aneurysm procedure, but, in particular, when faced with more complex cases and tortuous anatomies.
“It’s a really nice option to have and, as a result, we’ve ended up doing a lot less stent-assisted coiling because we aren’t relying on it up front; we know it’s there as a bailout strategy, but only in the cases that absolutely need it,” Davies continues.
And, providing a concluding message on what makes these results with Comaneci so pertinent to clinical practice, Davies says: “Wide-neck aneurysms are the hardest thing we’re treating right now, especially in ruptured cases, and having something temporary that obviates the need for DAPT is very useful. We recently published a paper on ‘nuisance bleeding’ following DAPT—something I think is more common than many clinicians outwardly acknowledge. So, having something temporary that doesn’t commit patients to DAPT unless they actually need it represents a tremendous tool in our armamentarium.”
These latest findings also bolster existing evidence on the Comaneci device’s ability to “empower” strong outcomes with the longstanding approach of coil embolisation, according to Hanel.
“For me, SUCCESS shows that Comaneci-assisted coiling is a very safe and effective real-world treatment for wide-neck intracranial aneurysms,” he comments. “It’s very exciting to have this tool available—and I think there’s definitely a role for temporary bridging in wide-neck aneurysm treatment.”
