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  • „PERFECT FIT“: Orion Pharma signs sales collaboration for DeltaScan® in Germany

    „PERFECT FIT“: Sales collaboration between Orion Pharma and Prolira for early detection and monitoring for acute encephalopathy and delirium.
    The companies ORION Pharma and Prolira are excited to announce their sales collaboration agreement that has been signed in June 2021. The agreement includes the Germany-wide promotion of DeltaScan®, a revolutionary medical device that objectively monitors the brain state of patients. Within minutes, the patient’s brain is assessed for signs of illness (acute encephalopathy and delirium). Monitoring the brain state of hospitalized patients is as important as monitoring other vital organs like the heart or the lungs. Until now this was difficult, as usual care only has subjective checklists with limited performance.

    With DeltaScan®, the brain state is objectively measured at the bedside using breakthrough EEG technology. DeltaScan® is a CE marked device, and is already in use in hospitals in the Netherlands, Germany and Austria in the field of intensive care medicine, geriatric traumatology, cardio thoracic surgery and emergency medicine.

    ORION Pharma is a proven, very well networked specialist in the field of intensive care medicine with a long history of expertise in delirium management, prevention and care. With the successful launches of dexdor® (dexmedetomidine) and SIMDAX® (levosimendan) , ORION Pharma has high professional competence and profound knowledge in intensive care and is a long-established and reliable partner for cardiologists, cardiac surgeons, anaesthetists and intensive care physicians, nurses and pharmacists in clinics in Europe. “The collaboration with Prolira secures our commitment as leading critical care specialist, improving outcomes in intensive care, post cardiac surgery and geriatric trauma patients significantly”, says Dr. Robert Borgdorf, Head of ORION Pharma Region Central Europe. “It has always been our goal to develop solution concepts in collaboration with our customers that really help critical ill patients. With DeltaScan we will continue this path in delirium management”, adds Dr. Markus Gutschow, Business Manager critical care.

    Prolira, a spin-off of the University Medical Center Utrecht (NL), an international and privately owned MedTech Scale Up company, has developed DeltaScan®. “Our objective is to further build our position as the first and only bedside EEG for medical decision making in brain state monitoring. The brain is our central organ and it provides an essential vital sign about the condition of the patient. Every year, as many as 10 million cases of acute brain failure occur in the US and Europe. Hence, there is a large group of patients that are in need of early detection and monitoring of acute encephalopathy and delirium”, says Rutger van Merkerk, MSc. PhD and CEO/Founder of Prolira. “We expect from this ’perfect fit’-collaboration with ORION Pharma a more rapid and increased use of DeltaScan® to improve outcome of this high-risk patient group”; confirms Sjoerd Kruijff, Chief Sales & Marketing of Prolira.

    DeltaScan® is an EU registered trademark (Certificate Nr 018280613)

    Prolira BV
    Headquarters:
    IJsselburcht 3
    6825 BS Arnhem
    The Netherlands


    Visiting address:
    Padualaan 8
    3584 CH Utrecht
    The Netherlands


    T.
    E.W.


    +31 (0)85 060 1656
    info@prolira.com
    www.prolira.com


    Prolira’s privacy statement
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    DeltaStudy successfully completed

    In this multicenter study, 434 patients measured with DeltaScan

    A large scale validation study for DeltaScan device performance was executed. Patient data was collected from a wide study population of 434 patients. The aim of the study was to investigate the diagnostic performance of the DeltaScan, a CE-certified device to detect acute encephalopathy and delirium using a brief electroencephalography (EEG) recording, separately in patients admitted to an Intensive Care Unit (ICU), and elderly patient admitted to the ward (non-ICU department). The design of the study was a Cross-sectional, multicentre study in 9 hospitals with 31 different departments; nearly 50% of the patients were in the ICU, the better half of the patients were in a variety of wards (e.g. cardiothoracic surgery, geriatric traumatology, geriatrics, internal medicine, etc). The study results show strong performance (>85% overall diagnostic accuracy) of DeltaScan for acute encephalopathy (a.k.a. delirium) in the variety of hospital departments.

    DeltaScan® is an EU registered trademark (Certificate Nr 018280613)

    Prolira BV
    Headquarters:
    IJsselburcht 3
    6825 BS Arnhem
    The Netherlands


    Visiting address:
    Padualaan 8
    3584 CH Utrecht
    The Netherlands


    T.
    E.W.


    +31 (0)85 060 1656
    info@prolira.com
    www.prolira.com


    Prolira’s privacy statement
    Cookie statement

    End of intervention phase of CLEO study reached

    Approximately 3000 patients measured with DeltaScan.

    With our consortium partners (UMC Utrecht, Charité and UZ Leuven and Key Opinion Leaders Prof Slooter, NL; Prof Spies, DE; Prof Milisen, BE) we carried out the international CLEO evaluation study with the purpose to evaluate DeltaScan in daily practice. The study was severely hampered by the COVID-19 pandemic, which made it impossible to reach the required inclusion numbers in the intervention phase of the study. Study sites did however get a good introduction to DeltaScan and most continue to use DeltaScan after their participation in the study. Other positive achievements of CLEO are:

    • Some 3000 patients in ICUs, cardiothoracic surgery ward and geriatric traumatology wards in the Netherlands, Germany and Belgium were measured several times with DeltaScan
    • on all participating departments the awareness for delirium has risen due to the study participation and presentations we gave
    • thousands of nurses made our e-learning Delirium and e-learning Prolira-DeltaScan use
    • hundreds of doctors made our e-learning Delirium and e-learning Prolira-DeltaScan use
    • thousands of nurses performed measurements with DeltaScan

    DeltaScan® is an EU registered trademark (Certificate Nr 018280613)

    Prolira BV
    Headquarters:
    IJsselburcht 3
    6825 BS Arnhem
    The Netherlands


    Visiting address:
    Padualaan 8
    3584 CH Utrecht
    The Netherlands


    T.
    E.W.


    +31 (0)85 060 1656
    info@prolira.com
    www.prolira.com


    Prolira’s privacy statement
    Cookie statement

    Label extension for DeltaScan with acute encephalopathy

    We are proud to announce that the intended use for DeltaScan® has been expanded. It now also includes the indication acute encephalopathy, in addition to the existing indication delirium. Encephalopathy means “disease of the brain” and acute encephalopathy is a sudden disturbance and change of (the condition of) the brain that can only be diagnosed on the basis of EEG. Acute encephalopathy often manifests as delirium. Delirium is diagnosed on the basis of clinical features.

    Both diagnoses are always characterized by an underlying physical cause. Acute encephalopathy and delirium are a medical emergency. Rapid diagnosis & timely treatment of underlying causes are important factors in limiting the severity and the duration of delirium and in reducing the risk of complications from it.

    From now on, we call it: DeltaScan Brain State Monitor.

    DeltaScan® is an EU registered trademark (Certificate Nr 018280613)

    Prolira BV
    Headquarters:
    IJsselburcht 3
    6825 BS Arnhem
    The Netherlands


    Visiting address:
    Padualaan 8
    3584 CH Utrecht
    The Netherlands


    T.
    E.W.


    +31 (0)85 060 1656
    info@prolira.com
    www.prolira.com


    Prolira’s privacy statement
    Cookie statement

    EU MDR certification for Prolira!

    Regulatory Milestone: Prolira has EU MDR certification!

    We are proud to announce that Prolira is one of the first medical device companies in the world, to be certified according to the new EU MDR.

    Prolira’s EU MDR certifiction is the result of a big team effort headed by Uschi and Rutger. We also wish to thank QAid for its full support and DARE!! Medical Certifications for the effective and constructive auditing and certification process.

    The European Medical Device Regulation (EU MDR) guarantees safety and quality requirements for medical devices being manufactured or imported into Europe. It underwent fundamental revisions in 2017 to improve transparency through standard data, technological advances and the creation of an EU (EUDAMED)database. While the MDD was simply a set of guidelines, MDR is legally enforceable by EU member states.

    DeltaScan® is an EU registered trademark (Certificate Nr 018280613)

    Prolira BV
    Headquarters:
    IJsselburcht 3
    6825 BS Arnhem
    The Netherlands


    Visiting address:
    Padualaan 8
    3584 CH Utrecht
    The Netherlands


    T.
    E.W.


    +31 (0)85 060 1656
    info@prolira.com
    www.prolira.com


    Prolira’s privacy statement
    Cookie statement

    The Epidemic within the Covid19 Pandemic: Delirium

    Article in New York Times (may 2020): Scores of phycisians from around the world report a rise in delirium of up to 70% because of Covid-19, says Dr Inouye (USA). It is occurring in both younger and older patients. Because of the restrictions on visitation and care to limit infection, Arjen Slooter, president of the European Delirium Association, told her, “it’s difficult to provide the humanistic care necessary to prevent delirium.” Dr. Slooter practices in the Netherlands, a world leader in Intensive Care Neuropsychiatry, but even there, he said, “All our patients are delirious, just like 20 years ago.”

    End of June 2020, the NY times published another article: ‘They Want to Kill Me’: Many Covid Patients Have Terrifying Delirium. Also in Dutch national Newspapers (Volkskrant, AD) and on the BBC television there was a lot of attention for the high delirium rate amongst COVID-19 patients. This virus is a ‘delirium factory’.

    DeltaScan® is an EU registered trademark (Certificate Nr 018280613)

    Prolira BV
    Hoofdkantoor:
    IJsselburcht 3
    6825 BS Arnhem
    The Netherlands


    Bezoekadres:
    Padualaan 8
    3584 CH Utrecht
    The Netherlands


    T.
    E.W.


    +31 (0)85 060 1656
    info@prolira.com
    www.prolira.com


    Prolira’s privacyverklaring
    Cookieverklaring

    Delirium care in St Antonius

    St Antonius hospital is one of the first users of DeltaScan, the objective EEG based device to detect & monitor for delirium. They strive to continuously improve delirium care, as it is a common complication. The longer delirium lasts, the worse the patient outcome. Watch this short movie to learn what the St Antonius healthcare professionals say about delirium!

    DeltaScan® is an EU registered trademark (Certificate Nr 018280613)

    Prolira BV
    Hoofdkantoor:
    IJsselburcht 3
    6825 BS Arnhem
    The Netherlands


    Bezoekadres:
    Padualaan 8
    3584 CH Utrecht
    The Netherlands


    T.
    E.W.


    +31 (0)85 060 1656
    info@prolira.com
    www.prolira.com


    Prolira’s privacyverklaring
    Cookieverklaring