Getinge releases Livit Flex – the next generation in bioprocess control

  

Getinge is launching Livit Flex – an intuitive system for bioprocess control that will enable pharmaceuticals and biotech products to reach the market faster.

In bioprocessing, where complete living cells or their components are used to obtain for example pharmaceuticals and cellular agriculture products – flexibility, customization, simplicity as well as time and cost-efficiency are key factors for process optimization.

“Livit Flex brings nearly half a century of expertise together with the latest technologies to deliver an intuitive and easily configurable bioprocess controller that fits any R&D application,” says Matthijs Niemeijer, Head of Product Management Bioreactor Systems at Getinge.

With Livit Flex, Getinge takes bioprocess control to the next level by releasing a state-of-the-art solution that speeds up development thanks to system flexibility, smart sensor technology and easy-to-use software functionalities.

By accessing and controlling multiple controllers from one PC or tablet in a laboratory, users can quickly set up parallel experiments and monitor all that data from one central location.

“Combining the flexibility of the Livit Flex controller, the intuitive Livit software and Getinge bioreactors enables acceleration of R&D processes to make sure that pharmaceuticals and biotech products will ultimately end up faster where they are most needed – with the patients,” says Matthijs.

Getinge’s bioreactors to support unique Dutch cellular agriculture initiative

 

 The Dutch government confirms allocation of €60 million to support an ecosystem around cellular agriculture, the technology used to produce animal products such as meat and milk proteins directly from animal and microbial cells. As member of the Cellular Agriculture Netherlands Foundation, Getinge will support the project with its bioreactors and bioreactor knowledge.

Getinge is part of the Cellular Agriculture Netherlands Foundation, which consists of a fast-growing community of 34 organizations (educational and knowledge institutions, NGOs, startups, industry) with the common goal of building a healthy cellular agriculture sector.

“Our bioreactors play an important role in the development of cellular agriculture,” says Timo Keijzer, Director Product Marketing at the product area Bio-Processing at Getinge. “By growing the cells in a closed environment, the bioreactor, you ensure that meat or fish is cultivated in a clean and controlled manner. This is critical for optimal growth of cells and therefore the development of healthy and nutritious food.”

The Dutch government’s financial support is the world's largest ever national government grant for cellular agriculture. It was reserved under conditions from the National Growth Fund in April of this year. The implementation of the plan will start under the coordination of the Cellular Agriculture Netherlands Foundation, in collaboration with the Ministry of Agriculture, Nature and Food Quality.

The confirmation of this public investment in cellular agriculture is an example of the commitment of the Dutch government to build a food system that is healthy and sustainable. Combined with reforms in traditional agriculture, cellular agriculture could provide an additional option to meet the growing demand for protein worldwide.

About the National Growth Fund

With the National Growth Fund, the government will allocate € 20 billion over the next five years for project investments in two areas with the most potential for structural and sustainable economic growth. For more information, see www.nationaalgroeifonds.nl/english

Getinge to support the American Heart Association in progressing care for cardiogenic shock patients

 

 

Today, Getinge announces its support of the American Heart Association initiative to build a Cardiogenic Shock Registry. This unparalleled initiative will enable a wide range of cardiogenic shock research, based on patient data from hospitals across the US, and lead to opportunities to promote best practices and improve clinical outcomes.

Historically, data related to cardiogenic shock has been limited, inconsistent, and challenging to interpret. If not treated quickly, cardiogenic shock can lead to organ failure and death. Even when treated timely and at specialized centers, the rate of survival after cardiogenic shock remains dismal. The American Heart Association initiative to collect evidence in cardiogenic shock patients across US hospitals and create a Cardiogenic Shock Registry in collaboration with academic clinicians, researchers, federal agencies and industry experts, is unparalleled.

“Cardiogenic shock is a life-threatening condition where the heart suddenly can’t pump enough blood to meet the body’s demands, and is often caused by a severe heart attack or advanced heart failure as a complication of a variety of heart conditions. It is a common cause of mortality and the management of these patients remains challenging despite advancement in therapeutic options,” says Dr. Pierluca Lombardi, Corporate Medical Officer at Getinge.

Getinge has a long history of providing products and solutions within the cardiovascular space, making the support to the American Heart Association in establishing its Cardiogenic Shock Registry very natural.

“The American Heart Association came up with a brilliant way of fostering collaboration among experts, and we want to support that. The data collected will provide high-quality evidence and important best practice treatments for health care stakeholders”, says Dr. Lombardi. “I’m convinced it will be a game changer for both clinicians and patients, and a step towards more equal and sustainable care.”

Getinge’s new DPTE®-EXO with Sleeveless DPTE-BetaBag takes aseptic transfer to a new level

 

Today Getinge releases the new DPTE-EXO with Sleeveless DPTE-BetaBag. It is a first of its kind alpha port with external opening and integrated funnel, securing automated aseptic transfer and improving operational efficiency for Life Science customers worldwide.

While discovering, developing and producing drugs, the pharma industry is facing increased demands on throughput and automation at the same time as GMP requirements are becoming stricter.

“As the industry evolves, the next generation of pharmaceutical manufacturing needs greater flexibility of the batch’s size to switch production quickly from one drug to another,” says Anneke Evers, Senior Director DPTE Sales & Market Support at Getinge.

Getinge’s new total solution DPTE-EXO with Sleeveless DPTE-BetaBag is an answer to customer needs, providing a secure, reliable, and automated transfer solution.

“The function with the external opening was designed to significantly reduce the risk of contamination while its connectivity offers a greater degree of traceability and data analysis. DPTE-EXO with Sleeveless DPTE-BetaBag supports the efforts to build safe, automated, and compliant filling lines.”

The motorized external opening alpha port combined with an optional funnel also provides operational efficiency by reducing manual intervention and freeing up time for the operator.

“It’s easy to use and has several smart controls governing its safe and efficient door opening and closing and funnel movements. It also integrates a specific program with an open door and funnel position suitable for the barrier system bio-decontamination cycle.”

She continues:

 “The DPTE-EXO with Sleeveless DPTE-BetaBag is a fully validated and interlocked system. Together with the dismountable funnels, it offers a total transfer solution from the outside to the process area. With this product launch, we want to be part of opening up the door to the future, supporting the exciting yet challenging pharma industry transition.”

Getinge releases updated version of endoscope washer-disinfector

 

 

Today, Getinge releases an updated version of the ED-Flow automated endoscope reprocessor. The new features bring a higher level of digital connectivity and data management to Getinge’s endoscope reprocessing customers, which will result in improved uptime and increased productivity.

Endoscopes are used in an increased number of procedures, making endoscope reprocessing an important part of any infection prevention plan. It is a complex process, given all the requirements for safe and reliable cleaning, storage, and transportation of endoscopes.

“Every time we develop new endoscope reprocessing solutions we focus on delivering value to our customers while maintaining the highest levels of safety and efficacy. Our solutions are designed for consistency, accuracy and cost-effective operations and our updated ED-Flow is no exception,” says Don Socha, Global Product Manager Endoscope Reprocessing at Getinge.

ED-Flow efficiently performs leak testing, cleaning and high-level disinfection of flexible endoscopes, delivering effective, reliable results. New process indicator lights have been added to allow easy visibility of the process status from across the room, which creates improved department workflow leading to higher productivity.

“Access to real-time digital process data makes it possible to better utilize our traceability software T-DOC with ED-Flow and also connect to Getinge Online. Getinge Online is a secure web portal that provides real-time and historical performance information of equipment to enable faster resolution of issues and gain insight on equipment utilization. By monitoring the operations remotely, hospitals can improve uptime, optimize workflow and more efficiently manage costs,” explains Don.

Getinge to acquire FLUOPTICS, a technology leader in the area of Near Infrared Imaging

 

Getinge announces today an agreement to acquire 100% of the shares in FLUOPTICS SAS, a French based leader in fluorescence imaging as an aid to surgery. The acquisition will expand Getinge’s customer offering in clinical decision support by providing safe and improved operating efficiency.

FLUOPTICS, based in Grenoble, France, was founded in 2009 and has since developed NIR imaging systems, consisting of a dedicated camera and the related software, to visualize the vascularization and other tissues by the use of a fluorescent marker or by using the natural autofluorescence of the tissues. FLUOPTICS’s solutions allows for visualizing physiological and biological phenomena that are invisible to the naked eye.

“With the acquisition of FLUOPTICS, we are opening a new chapter for our Surgical Workflows business by expanding into the field of advanced visualization and decision support for surgeons,” says Stéphane Le Roy, President Surgical Workflows. “We will create a unique ecosystem with surgical lighting, fluorescence imaging and digital solutions for image processing and management.”

The addressable global market is estimated to be more than SEK 2.5 B, recording an annual compounded average growth rate of 8 % during the forecasted period. More than 380 institutions in US, Europe and Asia are currently using the FLUOPTICS technology in their daily clinical routine with over 40,000 procedures performed. The development and the production will remain in Grenoble and will, together with Getinge’s existing site in Ardon France, shape Getinge’s Center of Excellence for Optics and Visualization.

“I am particularly happy to join forces with Getinge and our team is eager to leverage its impressive international network to reach all Operating Rooms in the world, “says Odile Allard, CEO of FLUOPTICS. “Together with Getinge R&D and commercial teams, we are confident that FLUOPTICS will be in the best position to accomplish our mission to establish a new standard in fluorescence imaging in the Operating Room”.

Getinge will, via its subsidiary Getinge Infection Control SAS, acquire all outstanding shares in Fluoptics and will pay approximately EUR 26 M in cash on closing. Moreover, additional earn-out may be paid if agreed milestones are achieved. The acquisition will be financed through available cash. Getinge expects no material integration costs. Until closing, Fluoptics will continue to operate as a wholly independent third party. 

The transaction is subject to, and conditional upon, foreign direct investment approval in France and other specific closing conditions. The transaction is expected to close before the end of the second quarter 2022.

Getinge launches new leg holder system compatible with a wide range of patient weight

 

 

Today Getinge launches a single leg holder system for OR tables. Compatible with two variants of knee crutches, it minimizes investments, saves time between surgeries and brings comfort to a wide range of patients.

Proper leg and foot positioning is essential for patient comfort and effective surgical site access in gynecology, obstetrics, urology, and proctology.

“Surgical staff won’t need to spend time switching leg holder between surgeries since our single system comes with two variants of knee crutches supporting up to 160 or 250 kg to fit a wide range of patients,” says Norman Gander, Product Manager at Getinge.

The knee crutches can be changed easy and quickly thanks to a click-interface in the locking system.

“A blade interface makes it possible to place the leg closer to the rotation point of the hip. This reduces strain on patients who have a limited range of motion in the hip joint. Side wings are included with the knee crutches to improve stability of the leg and prevent it from going outward.”

The leg holder adjustment angles varies from 85° upwards to 50° downwards, with abduction possibilities range from 10° to 23°.

“We are excited to launch this solution that will save time and investments for our customers, and bring comfort to a wide range of patients.”

Getinge is leading the way in Extracorporeal Life Support therapy

 

 Getinge is a world leading supplier of components to support Extracorporeal Life Support (ECLS) - a therapy that supports the function of lungs or a heart that has ceased working. 

Invented in the 1960s to facilitate heart bypass surgery, ECLS techniques and technologies have been refined to the point that they are used increasingly in Japan, Europe and, more recently, in the US.
 
“Basically, we take blood out of one of the big veins in the body," says David A. Kaufman, MD, Pulmonary & Critical Care Medicine at NYU School of Medicine in New York, US. "We run it through a chamber where we are able to extract the carbon dioxide and put in a high concentration of oxygen. Then, that blood is injected back into another vein."
 
ECLS is primarily a way to buy time and keep the blood oxygenated limiting the damage to the lungs in the most critical situations—like multi-organ failure—while doctors can figure out how to save the patient. The technique has potential in the case of trauma, while a patient awaits organ donations, or in the treatment of acute infectious disease, when a ventilator could cause damage. 
 
"There are times when a patient’s lungs are in such bad shape that the force that a mechanical ventilator needs to apply to get any gas into the lungs is very high," Dr. Kaufman says. "ECLS allows us to make sure that we're not adding to the damage that's already occurring from the patient's underlying disease."

Getinge has a broad, high-end product portfolio for short-term or prolonged ECLS that includes a choice of devices and consumables to provide individual and sufficient extracorporeal heart and lung support, such as centrifugal pumps, oxygenators, heater units, tubing sets, and catheters and cannulae. During the COVID-19 outbreak, ECLS therapy has provided support to acute care patients around the world in need of further life support than a ventilator can provide.

“We have seen a rising demand for ECLS therapy related products and will continue to increase our production to help our customers save more lives”, says Lena Hagman, EVP Quality & Regulatory Compliance & Managing Director Cardiopulmonary at Getinge. “Getinge has increased production output of Heart Lung Support (HLS) Advanced Sets and Permanent Life Support (PLS) Sets this year by more than 30% at our production facility in Hechingen and 110% in Rastatt and we have ambitious plans for continued growth.”

The significant investments at these manufacturing facilities in Germany are primarily related to increased production capacity. This includes various production tools, assembly machinery, coating equipment but also significant headcount increase of production employees.

Getinge has a world leading position in extracorporeal life support (ECLS) or extracorporeal membrane oxygenation (ECMO). In recent years customer demand has increased and due to the Covid-19 pandemic the demand has increased further. Therefore, Getinge is making significant investments in production to further support customers and patients worldwide.

Getinge has a broad, high-end product portfolio for short-term or prolonged extracorporeal life support (ECLS) or extracorporeal membrane oxygenation (ECMO) that includes a choice of devices and consumables to provide individual and sufficient extracorporeal heart and lung support, such as centrifugal pumps, oxygenators, heater units, tubing sets, and catheters and cannulae.

“We have seen a rising product demand for ECLS/ECMO therapy related products and will continue to increase our production to help our customers save more lives”, says Lena Hagman, EVP Quality & Regulatory Compliance & Managing Director Cardiopulmonary at Getinge. “Getinge has increased production output of Heart Lung Support (HLS) Advanced Sets and Permanent Life Support (PLS) Sets this year by more than 30% at our production facility in Hechingen and 110% in Rastatt and we have ambitious plans for continued growth“.

The significant investments at Getinge’s manufacturing facilities in Hechingen and Rastatt, Germany, are primarily related to increased production capacity. This includes various production tools, assembly machinery, coating equipment but also significant headcount increase of production employees.

On April 6, 2020, the US Food & Drug Administration issued guidance to temporarily expand the availability of devices used for extracorporeal membrane oxygenation (ECMO) therapy in the US. Cardiohelp and HLS Advanced Sets can now be used for long term (>6 hours) respiratory/ cardiopulmonary support in patients with Covid-19.

“We are doing our utmost to support healthcare workers and their patients during this global crisis”, says Lena Hagman.

Getinge develops digital platform together with Semcon to reduce the risk of infection during surgeries

In Sweden, infections are the most common hospital injuries – a problem that is
widespread even globally. According to an estimate by the European Centre for
Disease Prevention and Control, there are nearly 9 million cases of health care
associated infections in European hospital and long-term care each year.

"The project aims at helping health care facilities to reduce the number of health
care associated infections that can occur during operations," says Jonas
Andersson, Vice President Global Product Management, Infection Control at
Getinge. "We know that one in ten people in hospital today ends up with a
health care related infection. According to the research, there are many
endogenous and exogenous parameters that affect and in this project we want to
be able to evaluate how the environment in the operating room affects".

In the project, Getinge has chosen to collaborate with Semcon who has extensive

experience in both product development and software development, as well as
knowledge in medical technology.

"The digital platform that we are developing together with Getinge will help health

care professionals to better track a number of endorse-based risk factors.
Based on data from the platform, solutions can be developed to reduce the risk
of infections in surgical environments. This in turn can contribute to less
human suffering and reduced costs for health care," says Johan
Kristensson, Team Manager and Business Manager at Semcon.

By using a number of sensors in an operating theatre, the digital platform can

collect different types of data, which can both be viewed in real time and
analyzed afterwards. This creates a better understanding of what is happening
in the operating room and how to better work to reduce health care related
infections.

A prototype will soon be tested in an operating room at a hospital. The project

is based on a number of pre-studies that Semcon has done together with Getinge
and in the project Semcon contributes with cutting-edge expertise in embedded,
sensorics and UX.

Getinge contributes to Ventilator Manufacturers Group to form Ventilator Training Alliance and create app to help frontline medical workers during COVID-19 pandemic

Several of the world’s ventilator manufacturers announce a newly formed Ventilator Training Alliance (VTA) to support frontline medical providers to access a centralized repository of ventilator training. The content can be found in a mobile app managed by Allego.

“Supporting our customers and facilitating ventilator training continues to be key to all stakeholders in this project”, says Charles Merchant, Senior Director Global Therapy Development Acute Care Therapies at Getinge. “Dräger, GE Healthcare, Hamilton Medical, Medtronic, Philips, Vyaire Medical and Nihon Kohden, together with Getinge, have joined this humanitarian training coalition”.

The VTA app – powered by learning and readiness platform provider Allego – connects respiratory therapists, nurses and other medical professionals with ventilator training resources from alliance member companies, including instructional how-to videos, manuals, troubleshooting guides, and other ventilator-operation expertise critical to treating patients suffering from COVID-19-related respiratory distress.

Ventilators play a critical role in the management of patients who require assistance because they cannot breathe effectively due to severe respiratory illness, such as COVID-19. Speed and ease of access to ventilator training has a direct impact on patients’ health during the COVID-19 crisis.

Content on the VTA app can be accessed on iOS and Android devices — even in environments with little to no Wi-Fi access — or from a web browser. The app provides healthcare professionals’ multi-language closed captioning and mobile background audio when multitasking.

How to Access the Ventilator Training Alliance Hub

The app is provided at no cost to medical professionals. To download the Ventilator Training Alliance knowledge hub application, visit the Apple App Store or Google Play store, or click here to access the hub from any Web browser.

Getinge announces full market release of Servo-u 4.0 featuring innovations for personalized lung protection

 

Getinge announced today the full market release for the latest version of Servo-u 4.0, an innovative mechanical ventilator with groundbreaking solutions for automatic lung recruitment and transpulmonary pressure monitoring. The full release, means that Auto SRM (Automatic Stepwise Recruitment Maneuver) is now commercially available to all markets not requiring additional regulatory submission, in addition to the CE-mark.
“This release marks yet another milestone in Getinge’s extensive legacy of clinical innovations for Intensive Care Units worldwide,” says Jens Viebke, President Acute Care Therapies at Getinge. “Our goal is to help keep ventilated adult, pediatric and neonatal patients as safe and comfortable as possible with easy to use and clinically effective ventilator applications. With Servo-u 4.0, we have succeeded in consolidating our offering in the treatment and management of ARDS.”

The global burden of ARDS (Acute Respiratory Distress Syndrome) is estimated to exceed 3 million patients every year.¹ The treatment is complicated and associated with high mortality, long hospitalization and consumes significant health care resources.² ARDS still appears to be undertreated in terms of the use of recommended approaches to mechanical ventilation and use of adjunctive measures. These findings indicate the potential for improvement in treatment and management of patients with ARDS.³
“Since the limited market release, automatic lung recruitments using the Auto SRM have been performed on patients at hospitals in Spain, Sweden and the United Kingdom and in all cases the installation, training and adoption has worked as intended,” says Dr. Miray Kärnekull, Medical Director Critical Care at Getinge. “We are of course glad to hear that our peers have experienced the clinical benefits of our automatic lung recruitment workflow for these types of critically ill patients.”
Auto SRM is a standardized and automated workflow for lung recruitment. It visualizes settings, progress and determination of the patient´s closing Positive End-expiratory Pressure (PEEP), including assessment of recruitability. A post-recruitment summary, with color coded results and personalized settings provides further clinical decision-support.
Transpulmonary pressure monitoring is recommended as a method to better understand pathophysiology and improve clinical outcome for complex patients on mechanical ventilation.⁴ Its use, however, has been restricted to researchers and experts, because of the complex technology available. With the transpulmonary pressure monitoring application in Servo-u 4.0 customers are provided innovative features such as an automatic occlusion maneuver that validates positioning and filling of the esophageal balloon catheter, an intuitive therapeutic view and high resolution trending of key parameters for assessment of both passively ventilated and spontaneuosly breathing patients.

Getinge presents ICU portfolio and supports education at the International Symposium on Intensive Care and Emergency Medicine

 Getinge, a leading global provider of innovative medical technology, announces today it’s continuous commitment to ISICEM.                        

“As a major sponsor, Getinge will take the opportunity to present intensive care unit (ICU) products focusing on ICU ventilation, extracorporeal life support (ECLS) and advanced monitoring devices. Getinge will also participate and sponsor educational activities including two symposia. Also new this year, visitors can pre-book hands-on sessions for ECMO and ventilation and also participate in the simulation center,” shared Markus Stirner-Schilling, Senior Director, Acute Care Therapies, Global Commercial Operations.

The symposia; “can we do better for ARDS patients” will take place on Wednesday March 20th and the second symposia on “current dilemma between evidence based vs. personalized medicine” will take place the following day, Thursday March 21st.

It is anticipated that over 6,000 physicians, nurses and healthcare professionals with a focus on critical care or emergency medicine, from over 100 countries worldwide will attend this international meeting