Author: Rachael Hansford

Brain stimulation project could treat wide range of neurological disorders

21st August, 2023

Researchers from the University of Glasgow, UK are part of a cross-Europe project which is aiming to develop a revolutionary new method of treating a wide range of neurological disorders.

The Wireless Deep Brain Stimulation Through Engineered Multifunctional Nanomaterials project, or BRAINSTORM, is setting out to develop tiny injectable magnets which could help restore function to damaged neurons in patients’ brains. 

The BRAINSTORM team hope that their research could treat, or even cure, conditions like depression, panic attacks, epilepsy, Alzheimer’s disease or Parkinson’s disease.

The nanoscale magnets the team will develop will eventually be injected into rodents’ bloodstreams in a preclinical study and controlled using external magnets to deliver neurostimulation to specific neurons in their brains. 

Neurostimulation, which uses electrical currents or magnetic fields to modulate the activity of nerves or neural circuits, is already in use to treat a variety of brain-related conditions, often accompanied by surgeries to implant the electrodes which deliver the treatments. 

Over the next four years, researchers from the University of Glasgow will partner with colleagues from Germany, Italy, Spain and Finland to develop the BRAINSTORM technology, which could deliver improved results with less invasive techniques.

The project is supported by €3m (£2.57m) from the European Innovation Council’s Pathfinder programme. The Pathfinder programme provides funding for researchers to develop emerging breakthrough technologies.

Hadi Heidari, Professor of Nanoelectronics at the James Watt School of Engineering, is leading the University of Glasgow’s contribution to BRAINSTORM. 

He and his team at the School’s Microelectronics Lab will develop a wearable helmet-like device that will use magnets to control the positioning of nanomaterials, enabling neuromodulation treatments to be precisely targeted in the brain.

Neuromodulation is a treatment that has shown a great deal of potential for treating many conditions. However, our present methods of delivering neuromodulation can require invasive surgeries to implant electrodes, which can be expensive, painful and expose patients to an increased risk of infection. 

Hadi Heidari, Professor of Nanoelectronics at the James Watt School of Engineering

“BRAINSTORM is an exciting new opportunity to rethink how wireless neuromodulation is delivered. It builds on recent advances in magnetic coil nanofabrication, materials science and medicine to allow us to find new ways to precisely ‘switch on’ or ‘switch off’ neuronal activity for therapeutic effects. 

“I’m pleased to be working with my colleagues across Europe on this research, and I’m looking forward to developing some of the key technologies which will help patients benefit from new treatments in the years to come.”

BRAINSTORM Is led by Professor Danijela Gregurec of the Friedrich-Alexander-Universität Erlangen-Nürnberg in Germany. Researchers from CIC biomaGUNE in Spain, Tor Vergata University in Italy, and the University of Helsinki in Finland are contributing to the project along with the University of Glasgow. 

For more information on BRAINSTORM, visit https://www.brainstorm-project.eu

Can the scent of essential oils improve memory?

From Medscape, August 8th 2023.

Inhaling a pleasant aroma during sleep has been linked to an improvement in memory, small-scale early research suggests. Researchers randomly assigned 43 older adults, aged 60 – 85 years, to receive either nightly exposure to essential oil scents delivered via a diffuser (n = 20; mean [SD] age, 70.1 [6.6] years) or to a sham control with only trace amounts of odorants (n = 23; mean age, 69.2 [7.1] years) for a period of 6 months.

They found that when cognitively normal individuals were exposed to the scent of an essential oil for 2 hours every night over 6 months, they experienced a 226% improvement in memory compared with a control group who received only a trace amount of the diffused scent. A caveat is that several measures of cognitive function were assessed and only one (verbal memory) showed clear improvement. In addition, functional magnetic resonance imaging (fMRI) showed that those in the enriched group had improved functioning of the left uncinate fasciculus, an area of the brain linked to memory and cognition, which typically declines with age.

The study was published online on July 24th in Frontiers of Neuroscience. It concluded “Minimal olfactory enrichment administered at night produces improvements in both cognitive and neural functioning. Thus, olfactory enrichment may provide an effective and low-effort pathway to improved brain health.”

Ketogenic diet in RRMS

Study suggests benefits may be long lasting

Following a ketogenic diet for six months significantly reduced measures of body fat and fatigue, eased disease symptoms, and improved exercise capacity, cognition, and arm and hand dexterity in people with relapsing-remitting multiple sclerosis (RRMS), a study has shown. The research, Ketogenic diet in relapsing multiple sclerosis: Patient perceptions, post-trial diet adherence & outcomes, was published in the journal Clinical Nutrition.

Some benefits lasted for at least three months after the study ended, though several measures worsened – mainly due to difficulties in maintaining a strict ketogenic diet in the real world. 58% followed the diet after the trial ended, according to the data.

Following the 6-month KD intervention study, the majority of subjects elected to continue on KD, though many pursued a more liberal limit for carbohydrate restriction. Those who experienced a greater reduction in BMI or fatigue were more likely to continue with strict KD. The 6-month KD intervention induced persistent changes to dietary habits in the months following study completion.

Oxygen for brain injuries – can it help patients?

Inhaling oxygen while learning a motor task helped healthy people learn more quickly and effectively, raising hopes for neurorehabilitation 

Scientists studying the impact of oxygen supplementation on motor learning have found a promising treatment that could help patients who have experienced neurological trauma recover old skills. “A simple and easy to administer treatment with 100% oxygen can drastically improve human motor learning processes,” said Dr Marc Dalecki, now at the German University of Health and Sports in Berlin, senior author of the study in Frontiers in Neuroscience.

In high-oxygen contexts cognitive function recovers, and the delivery of 100% oxygen is already used to help preserve as much of the brain as possible in patients with neurological injuries. Motor learning is particularly dependent on oxygen-reliant information processing and memory functions: humans learn by trial and error, so the ability to remember and integrate information from previous trials is critical to efficient and effective motor learning. So could supplementing oxygen while learning a motor task help people learn faster and more effectively, offering hope for neurorehabilitation patients? 

“I had this idea in my mind for almost a decade and promised myself to investigate it once I got my own research lab,” said Dalecki, who led the experimental research at the School of Kinesiology at Louisiana State University. “And with Zheng Wang, now Dr Zheng Wang, I had the perfect doctoral student to run it – a keen physiotherapist with a clinical background and stroke patient experience.”  

Dalecki and Wang recruited 40 participants, 20 of whom received 100% oxygen at normobaric pressure and 20 of whom received medical air (21% oxygen) through a nasal cannula during the ‘adaptation’ or learning phase of a task. Dalecki and Wang selected a simple visuomotor task which involved drawing lines between different targets on a digital tablet with a stylus: the task was designed to test how quickly the participants were able to integrate information from the eye and hand, a crucial part of motor learning. After the task had been learned, the alignment of the cursor and the stylus was altered to see how effectively the participants adapted to the inconsistency, and then realigned for a final session to see how they adapted to the realignment. 

“The oxygen treatment led to substantially faster and about 30% better learning in a typical visuomotor adaptation task,” said Wang, first author of the study and now at the Mayo Clinic in Rochester. “We also demonstrate that the participants were able to consolidate these improvements after the termination of the oxygen treatment.”

The scientists found that the participants who had received oxygen learned faster and performed better, improvements which extended into later sessions of the task when oxygen was not administered. The oxygen group moved the pen more smoothly and more accurately, and when the cursor was adjusted in a deliberate attempt to throw them off, they adapted more quickly. They also made bigger mistakes when the alignment of the stylus was corrected, suggesting they had integrated the previous alignment more thoroughly than the other group. 

Dalecki and Wang plan to investigate the long-term effects of this supplementation on learning and test the intervention with other motor learning tasks: it is possible that the relevant brain functions for this task in particular benefit from high ambient oxygen levels, leading to the observed advantages in performance. They also hope to bring the oxygen treatment to elderly and injured people, in the hope that it will help them re-learn motor skills.

Our future plan is to investigate whether this treatment can also improve motor recovery processes following brain trauma. Since it worked in the young healthy brain, we expect that the effects may even be larger in the neurologically impaired, more vulnerable brain.

Dr Marc Dalecki

Epilepsy associated with CDKL5 Deficiency Disorder

European Commission Approval of ZTALMY® (ganaxolone) for the Adjunctive Treatment of Epileptic Seizures Associated with CDKL5 Deficiency Disorder

31 July 2023: Marinus Pharmaceuticals announced that the European Commission (EC) has granted approval of ZTALMY® (ganaxolone) oral suspension for the adjunctive treatment of epileptic seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients two to 17 years of age. ZTALMY may be continued in patients 18 years of age and older. ZTALMY is the first treatment approved by the European Commission for seizures associated with CDKL5 deficiency disorder in children and adolescents.

The EC approval of ZTALMY in CDD is supported by data from the Phase 3 Marigold double-blind placebo-controlled trial, in which 101 patients were randomised and individuals treated with ZTALMY showed a median 30.7% reduction in 28-day major motor seizure frequency, compared to a median 6.9% reduction for those receiving placebo, achieving the trial’s primary endpoint (p=0.0036). In the Marigold open label extension study, patients treated with ZTALMY for at least 12 months (n=48) experienced a median 49.6% reduction in major motor seizure frequency. In the clinical development programme, ZTALMY demonstrated efficacy, safety and tolerability with the most common adverse reactions (incidence ≥5% and at least twice the rate of placebo) in the ZTALMY group being somnolence, pyrexia, salivary hypersecretion and seasonal allergy. In May 2022, the results from the Marigold study were published in The Lancet Neurology.1

The approval follows a positive opinion issued in May 2023 by the Committee for Medicinal Products for Human Use of the European Medicines Agency and is applicable to all 27 European Union member states plus Iceland, Norway and Liechtenstein. In July 2021, Marinus and Orion Corporation entered into a collaboration agreement which grants Orion the right to commercialise ZTALMY in Europe.

The approval by the European Commission represents a significant milestone for children, families and physicians who, until now, have long been challenged by the impact of seizures and lack of treatments available for CDD. This achievement reflects our organisation’s unwavering commitment to bring an effective treatment option to individuals living with CDD and we are grateful to all the stakeholders who made the approval possible.

Scott Braunstein, M.D., Chairman and Chief Executive Officer of Marinus

References

1 The Lancet Neurology, Volume 21, Issue 5, P417-427, May 01, 2022

2 Olson H et al. 2019 Pediatric Neurology

3 Jakimiec M et al. 2020 Brain Sci.

About CDKL5 Deficiency Disorder

CDKL5 deficiency disorder (CDD) is a serious and rare genetic disorder characterised by early‑onset, difficult‑to‑control seizures and severe neuro‑developmental impairment.2 It is caused by a mutation of the cyclin-dependent kinase-like 5 (CDKL5) gene, located on the X chromosome. The CDKL5 gene produces a protein that is important for normal brain development and function.3

About ZTALMY®

ZTALMY (ganaxolone) is a neuroactive steroid GABAA receptor modulator that acts on a well-characterised target in the brain known to have anti-seizure effects. ZTALMY is an oral prescription medicine approved by the European Commission for the adjunctive treatment of epileptic seizures associated with CDKL5 deficiency disorder in patients two to 17 years of age. ZTALMY may be continued in patients 18 years of age and older.

AI enhances clinical decision-making in radiology

AI solution will help improve patient outcomes by providing timely and accurate detection of critical abnormalities

Milton Keynes University Hospital NHS Foundation Trust (MKUH) will use Qure’s qER for automating the detection of critical and life-threatening abnormalities in head CT scans, including intracranial haemorrhages (ICH) caused by trauma, accidents or strokes.

It is an FDA cleared and EU MDR Class IIb certified solution, and will be used for all non-contrast CT scans at the Trust. The solution aids in triaging critical cases, within three minutes, in the emergency department, especially during out-of-hour shifts when a larger team may not be available.

“This is a great step forward for frontline A&E patient care and we are delighted to partner with Blackford to bring qER to Milton Keynes University Hospital,” said Darren Stephens, Senior Vice President & Commercial Head UK and Europe of Qure.ai. “Our AI solution will help improve patient outcomes by providing timely and accurate detection of critical abnormalities, enabling clinicians to make informed decisions and take appropriate actions.”

The partnership between Blackford and Qure.ai is part of an ongoing effort to leverage AI technology to enhance clinical decision-making. MKUH procured the Blackford Platform to underpin its AI strategy and make evaluation, adoption, monitoring, and support of AI more efficient. qER by Qure.ai is one of the first AI solutions to be successfully evaluated and deployed via the Blackford Platform at MKUH. By automating the detection of critical abnormalities in head CT scans, qER can help clinicians save time and focus on providing the best possible care for patients.

“Blackford is committed to delivering AI solutions that broaden clinical and operational AI usage and drive additional value for healthcare organisations and their patients. Our model of partnering with best-of-breed AI providers like Qure.ai to tailor solutions via our tried-and-tested platform makes it easier and more efficient for healthcare providers like MKUH to evaluate and deploy AI and generate immediate and ongoing value.

Ben Panter, Blackford CEO

About Blackford

Blackford are pioneers in the radiology AI space, with over a decade of experience working in partnership with leading hospitals and ground-breaking technology providers. They operate as a strategic AI partner, providing access to a tried-and-tested core platform, tailored services and a portfolio of 100+ applications to help healthcare providers unlock the value of AI and improve patient outcomes. The company’s collaboration and recent arms-length acquisition by Bayer ensures that customers and partners have the support and long-term security needed to underpin successful AI strategies.

Visit www.blackfordanalysis.com

Positive CHMP opinion for multiple sclerosis biosimilar natalizumab

  • If approved, it will be first-of-a-kind biosimilar natalizumab in Europe, for use in all indications of reference biologic
  • Positive CHMP opinion is based on evidence from extensive analytical characterisation confirming similarity of biosimilar with reference biologic, in addition to Phase I and confirmatory Phase III studies in RRMS patients

July 24, 2023 — Sandoz, a global leader in off-patent (generic and biosimilar) medicines, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has adopted a positive opinion for marketing authorisation for first-of-a-kind biosimilar natalizumab developed by Polpharma Biologics.

The authorisation covers treatment as a single disease-modifying therapy (DMT) in adults with highly active relapsing-remitting multiple sclerosis (RRMS), the same indication as approved by the EMA for the reference biologic.1

Sandoz entered into a global commercialisation agreement for biosimilar natalizumab with Polpharma Biologics in 2019. Under this agreement, Polpharma Biologics will maintain responsibilities for development of medicine, manufacturing, and supply of drug substance. Through an exclusive global license, Sandoz has the rights to commercialise and distribute it in all markets.

Access to affordable, high-quality treatments like disease-modifying therapies – which are a cornerstone in the treatment of multiple sclerosis – remains limited for many people living with this disease. At Sandoz, we are committed to accelerating access to potentially life-changing treatments to patients in need around the world. Today’s positive opinion from the CHMP is a clear step in the right direction to address the burden of the disease for those living with multiple sclerosis while also delivering savings for healthcare systems.

Pierre Bourdage, Chief Commercial Officer

The comprehensive analytical, preclinical, and clinical data regulatory submission package included evidence derived from an extensive analytical characterisation, in addition to results from a Phase I PK/PD study and a confirmatory Phase III Antelope study in RRMS patients. Both studies met their primary endpoints, showing that the biosimilar matches the reference biologic in terms of pharmacokinetics as well as efficacy, safety and immunogenicity.

References

  1. European Medicines Agency (EMA). Tysabri EPAR. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/Tysabri [Accessed April 2023]
  2. MS International Federation. What is MS? October 2021. Available from: https://www.msif.org/about-ms/what-is-ms [Accessed April 2023]
  3. Mayo Clinic. About Multiple Sclerosis. 2022. Available from: https://www.mayoclinic.org/diseases-conditions/multiple-sclerosis/symptoms-causes/syc-20350269 [Accessed April 2023]
  4. Research Outreach. The Financial Toxicity of Multiple Sclerosis. August 2021. Available from: https://researchoutreach.org/articles/financial-toxicity-multiple-sclerosis [Accessed April 2023] 

SPRAVATO® for adults with treatment-resistant major depressive disorder

Findings presented at Royal College of Psychiatrists International Congress (RCPsych 2023) confirm the importance of SPRAVATO® as a therapeutic option for adults with treatment-resistant major depressive disorder in patients with 2 and >3 prior treatment failures.1

10 July 2023: The Janssen Pharmaceutical Companies of Johnson & Johnson announced further findings from the ESCAPE-TRD study. Data shows that treatment with esketamine nasal spray (NS) increased the likelihood of remission versus treatment with quetiapine extended release (XR) in sub-groups of treatment resistant depression (TRD) patients that had 2 and ≥3 prior treatment failures in the current episode.1 At Week 32, significantly more patients treated with esketamine NS vs quetiapine XR achieved remission in both sub-groups, 59.6% vs 41.3% in the group with 2 prior treatment failures (P≤0.001); 48.1% vs 29.8% in the group with ≥3 prior treatment failures (p<0.01). 1 Furthermore the time to remission was shortened with esketamine NS in both sub groups; patients with 2 and ≥3 prior treatment failures were respectively 1.5 ([1.21, 1.98]; p<0.001) and 2.0 times ([1.47, 2.91]; p<0.001) as likely to achieve remission at any timepoint versus quetiapine XR, when both were dosed as per their respective labels and used in combination with a continuing selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI). 1

The findings were presented at the Royal College of Psychiatrists International Congress (RCPsych 2023) 10 July to 13 July in Liverpool, United Kingdom, following earlier top line data from the study presented at the German Association for Psychiatry, Psychotherapy and Psychosomatics (DGPPN) Congress last year, and further findings presented at the 31st European Congress of Psychiatry (EPA 2023) in March of this year.1,2,3 “We are excited that new treatments for depression are being developed, particularly for severe depression where patients have not responded to existing medications and other interventions,” says Marjorie Wallace, Chief Executive of SANE. “There has been a dearth of new ideas, which is why so many patients are given repeat prescriptions of drugs made available over 30 years ago. The only way forward is to encourage those in a position to do so to develop innovative treatments that may potentially transform the future of those whose suffering may drive them to debilitation and despair.” Approximately a third of people who experience major depressive disorder (MDD) do not respond to treatment and are considered to have TRD – a term for people living with MDD who have tried two or more antidepressant treatments without experiencing any relief.4,5 MDD and TRD can be serious and debilitating conditions and are much more common in the UK than people may think – MDD affects around one in five people in the UK at some point in their lives.6


“Patients who have experienced three or more prior treatment failures are typically less likely to respond to the current treatments available for TRD. These findings demonstrate the significant effect esketamine nasal spray has in patients living with the condition in both sub-groups, and an even greater relative effect in those with three or more prior treatment failures. This marks a major milestone in offering a potential treatment option that could improve quality of life for these individuals.

Professor Allan Young, Director, Centre for Affective Disorders, Institute of Psychiatry, Psychology and Neuroscience, King’s College London

ESCAPE-TRD is a long-term, comparative, randomised, open-label, rater-blinded Phase IIIb clinical study designed to evaluate the short- and long-term efficacy, safety and tolerability of flexibly dosed esketamine NS compared with quetiapine XR, both in combination with a continuing SSRI or SNRI, in adults with TRD.2,7

“We are pleased to be presenting our latest data at RCPsych 2023 today. Our findings further inform us of the types of patients that may benefit the most from esketamine nasal spray and the potential positive effect it could have on their daily lives.” said Megan Walker, Therapeutic Area Medical Director, Neuroscience, Janssen-Cilag GmbH, part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Findings presented at RCPsych 2023 showed that the percentage of patients who achieved remission increased over time with either 2 or >3 prior treatment failures in both treatment options but was consistently higher in the esketamine NS treatment arm compared with quetiapine XR treatment arm.1 Esketamine NS was shown to demonstrate a superior remission rate in patients with >3 prior treatment failures, with patients 2.6 times as likely to achieve remission* at Week 8 versus quetiapine XR.1 At Week 8, 28.0% of patients treated with esketamine NS achieved remission compared to the 10.9% of patients being treated with quetiapine XR. 1

In addition, a significantly† greater proportion of patients with >3 prior treatment failures were relapse-free through Week 32 after remission at Week 8.1 Notably at Week 32, 18.2% of patients treated with esketamine NS were relapse-free after remission at Week 8 compared with 7.8% of patients treated with quetiapine XR. 1

Participants in the esketamine NS study arm with 2 prior treatment failures demonstrated a higher rate of remission at Week 8, compared with patients in the quetiapine XR study arm, 26.5% versus 21.8% respectively. 1 After remission at Week 8, 24.0% of patients in the esketamine NS study arm were relapse-free through Week 32 compared with the 18.0% of patients in the quetiapine XR treatment arm. 1


*Remission was defined as Montgomery-Åsberg Depression Rating Scale [MADRS] total score ≤10. MADRS is a clinician‐rated measure of depression severity.1

† Tested at a two-sided 0.05 significance level without adjustment for multiple testing. 1

References

1 Young AH. et al., Esketamine nasal spray improves rate and time to remission versus quetiapine extended release in subgroups of patients with treatment resistant depression and two or three plus prior treatment failures: Results from ESCAPE-TRD, a randomised phase IIIb trial. Presented at RCPsych 2023, July 10-13. Poster PO-424.
2 Reif A. et al., Esketamine nasal spray improves short‐ and long‐term outcomes compared with quetiapine extended release in patients with treatment resistant depression: First results from ESCAPE‐TRD, a randomised, multi‐centre phase IIIb clinical trial. Presented at DGPPN 2022, November 23-26. Poster P-01- 04.
3 Reif A. et al., Esketamine nasal spray shows higher remission and response rates over 32 weeks of treatment compared with quetiapine extended-release in patients with treatment resistant depression: Results from EXCAPE-TRD, a randomized, phase IIIb clinical trial. Presented at EPA 2023, March 25-28. Poster PO0067.
4 Ionescu DF, et al., Dialogues Clin Neurosci 2015;17(2):111–126. European Medicines Agency, 2013. Guideline on clinical investigation of medicinal products in the treatment of depression. Available at: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicinal-products-treatment-depression_en.pdf. Last accessed: July 2023.
CP- 399452 July 2023
5 National Institute for Health and Care Excellence. Implanted vagus nerve stimulation for treatment-resistant depression. Available at: https://www.nice.org.uk/guidance/ipg679/resources/implanted-vagus-nerve-stimulation-for-treatmentresistant-depression-pdf-1899874293371845. Last accessed: July 2023.
6 Smith, D., et al., Prevalence and Characteristics of Probable Major Depression and Bipolar Disorder within UK Biobank: Cross-Sectional Study of 172,751 Participants. 2013. Plos ONE, 8(11), e75362. doi: 10.1371/journal.pone.0075362.
7 Clinicaltrials.gov. A long-term comparison of esketamine nasal spray versus quetiapine extended release, both in combination with a selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor, in participants with treatment resistant major depressive disorder (ESCAPE-TRD). NCT 04338321.Available at: https://clinicaltrials.gov/ct2/show/NCT04338321?term=escape-trd&draw=2&rank=1. Last accessed: July 2023.
8 Mrazek DA, et al., A review of the clinical, economic, and societal burden of treatment-resistant depression: 1996-2013. Psychiatr Serv. 2014 Aug 1;65(8):977-87. doi: 10.1176/appi.ps.201300059.
9 Amos TB, et al., Direct and Indirect Cost Burden and Change of Employment Status in Treatment-Resistant Depression: A Matched-Cohort Study Using a US Commercial Claims Database. J Clin Psychiatry. 2018 Mar/Apr;79(2):17m11725. doi: 10.4088/JCP.17m11725.
10 Souery D, et al., Clinical factors associated with treatment resistance in major depressive disorder: results from a European multicenter study. J Clin Psychiatry. 2007 Jul;68(7):1062-70. doi: 10.4088/jcp.v68n0713.
11 Hillhouse TM, Porter JH. A brief history of the development of antidepressant drugs: from monoamines to glutamate. Exp Clin Psychopharmacol. 2015 Feb;23(1):1-21. doi: 10.1037/a0038550.
12 Electronic Medicines Compendium. Spravato 28 mg nasal spray, solution. Available at: https://www.medicines.org.uk/emc/product/10977/smpc#gref. Last accessed: July 2023
13 Paul R, et al., Comparison of racemic ketamine and S-ketamine in treatment-resistant major depression: report of two cases. World J Biol Psychiatry. 2009;10(3):241-4. doi: 10.1080/15622970701714370.
14 European Medicines Agency. Summary of Product Characteristics. Spravato 28 mg nasal spray. Janssen Cilag International

Improvements in treatment of intracranial aneurysms

Meta-analysis shows fewer complications and higher occlusion rates for ruptured wide-neck intracranial aneurysms, using Rapid Medical’s COMANECI™ Embolisation Assist Device

19 July 2023: Rapid Medical™, developer of advanced neurovascular devices, has announced new clinical data showing significant advantages of its novel COMANECI™ embolisation assist device over established techniques to treat ruptured wide-neck intracranial aneurysms. A recent meta-analysis published in World Neurosurgery found that COMANECI is associated with lower haemorrhagic and thromboembolic complication rates, higher complete occlusion rates, and similar residual retreatment rates than stent-assisted and balloon-assisted coiling techniques.

As the only adjustable, non-occlusive device for haemorrhagic stroke treatment, COMANECI’s visible mesh conforms to the anatomy, providing stent-like support without the complications of a permanent stent or halting blood flow like a balloon. It has been used in over 12,000 procedures worldwide in wide-neck aneurysm treatments–and in Europe only–to open arteries constricted by vasospasm.

Researchers at the University at Buffalo and George Washington University compared the three devices by pooling over 3200 ruptured aneurysms across 64 studies. No significant differences were found between SAC and BAC. However, COMANECI-assisted coiling showed significantly lower thromboembolic and aneurysmal complication rates and periprocedural complications – than both SAC and BAC. Furthermore, COMANECI demonstrated statistically better complete occlusion rates than SAC and equivalent rates to BAC.

The COMANECI device is a highly useful adjunct tool for patients with subarachnoid haemorrhage. While stent-assisted coiling (SAC) and balloon-assisted coiling (BAC) are widely used therapies, each method has unique drawbacks that are nicely addressed with the COMANECI device

Study author Adnan Siddiqui, MD, PhD, Vice-Chairman and Professor of Neurosurgery of the University at Buffalo and CEO of the Jacobs Institute

Read ACNR stroke articles.