Medical Devices
Medtronic | January 05, 2024
Medtronic plc a global leader in healthcare technology, announced it has received CE Mark for its Micra™ AV2 and Micra™ VR2, the next generation of its industry-leading miniature, leadless pacemakers.
Micra AV2 and Micra VR2, the world's smallest pacemakers, provide longer battery life and easier programming than prior Micra pacemakers, while still delivering the many benefits of leadless pacing such as reduced complications compared to traditional pacemakers.2
With approximately 40% more battery life compared to previous generations,1 Medtronic projects the battery life of Micra AV2 and Micra VR2 is nearly 16 and 17 years, respectively.3 This means more than 80% of patients who receive a Micra may only require one device for life.3
This CE Mark milestone follows U.S. Food and Drug Administration approval for the Micra AV2 and VR2 devices in 2023.
In addition to size and longevity benefits, Micra devices are also the only leadless pacemakers with remote monitoring capabilities, which allow a doctor or clinic to check on a patient's heart device without the need for a patient to travel to their clinic for an in-person appointment. Other patient benefits of remote monitoring may include a reduction in hospitalizations and increase in sense of security.4,5
"For more than eight years, our Micra leadless pacemakers have provided meaningful benefits to people in Europe who require a pacemaker. Now, these patients have access to the latest leadless pacing technology that, for most of them, may be the only device they will ever need," said Robert C. Kowal, M.D., Ph.D., general manager, Cardiac Pacing Therapies within the Cardiac Rhythm Management business, which is part of the Cardiovascular Portfolio at Medtronic.
"The first generation of leadless Micra pacemakers demonstrated a significant reduction in major complications, and this next generation of Micra brings several additional benefits including greater longevity, and specifically for the Micra AV2, new algorithms to optimize AV synchrony at faster heart rates while requiring less in-office programming," said Prof. Dr. Christophe Garweg, Cardiologist at University Hospitals of Leuven, Belgium. "These advantages likely will expand the use of the leadless pacemaker to more patients."
Globally, more than 200,000 patients have received Micra pacemakers.6 Comparable in size to a large vitamin, Micra pacemakers are less than one-tenth the size of traditional pacemakers. Unlike traditional pacemakers, Micra pacemakers do not require leads or a surgical "pocket" under the skin, so potential sources of complications related to leads and pockets are eliminated, and there is no visible sign of the device.
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day.
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Medical Devices
Medtronic | January 08, 2024
Medtronic plc a global leader in healthcare technology, today announced CE (Conformité Européenne) Mark approval for the MiniMed™ 780G system with Simplera Sync™, a disposable, all-in-one continuous glucose monitor (CGM) requiring no fingersticks or overtape. Simplera Sync™ features an improved user experience with a simple, two-step insertion process and is half the size of previous Medtronic sensors.
The MiniMed 780G system with Simplera Sync™ sensor will be available in Europe via limited release in spring 2024. Medtronic will begin the phased commercial launch in Europe in the summer of 2024. Today, the MiniMed™ 780G system can be used with the Guardian™ 4 sensor.
The MiniMed™ 780G system is Medtronic's most advanced insulin delivery system, automatically adjusting and correcting† glucose levels every 5 minutes.§ It's the world's only system with a Meal Detection™ feature‡ that is designed to reduce post-meal hyperglycemia when users occasionally forget to give themselves insulin or underestimate the number of carbs in their snacks or meal. The system, which is available with the world's only 7-day infusion set, also features one of the lowest glucose target settings (as low as 100 mg/dL) of any automated insulin delivery system. With this "treat to target" approach, the system more closely mirrors the glucose levels of someone not living with diabetes. With both Simplera Sync™ sensor and the Guardian™ 4 sensor, no fingersticks are required.
"A challenging aspect of living with diabetes is counting carbohydrates and dosing the right amount of insulin before consuming snacks and meals. Many people underestimate their carbs, which can lead to high blood sugars (hyperglycemia). Prolonged hyperglycemia can lead to serious health problems impacting the eyes, major organs, and even cognitive function, which is particularly concerning in developing children," Robert Vigersky, M.D., Chief Medical Officer, Medtronic Diabetes, Professor of Medicine, Uniformed Services University of the Health Sciences "With its responsive algorithm, the MiniMed™ 780G system can help people living with diabetes even when they occasionally forget to bolus or undercount their carbs. The system takes on more of the work involved in diabetes management and helps alleviate mental burden."
"We're incredibly proud that the MiniMed™ 780G system continues to be the most widely used automated insulin delivery system in Europe since we launched it in 2020. Real-world data on over 100,000 users on the system across many geographies and cultures shows that when using recommended settings the system is delivering an average Time in Range of nearly 80%, raising the bar on what 'good' looks like2," said Que Dallara, EVP and President, Medtronic Diabetes. "With the introduction of Simplera Sync™ sensor, we're able to offer the proven benefits of our MiniMed™ 780G system with our newest and most comfortable sensor that can be applied in under 10 seconds."
The MiniMed™ 780G system with Simplera Sync™ sensor is indicated for ages 7+ and compatible with iOS and Android. Simplera Sync™ sensor is not approved by the FDA and is limited to investigational use in the U.S.
Simplera Sync™ sensor is designed to leverage Medtronic's advanced AID algorithm as part of its MiniMed™ 780G system while having a similar look and feel as the Simplera™ CGM. The Simplera™ CGM for integrated use with the InPen™ smart insulin pen received CE Mark in September 2023.
About the Diabetes Business at Medtronic
Medtronic Diabetes is on a mission to alleviate the burden of diabetes by empowering individuals to live life on their terms, with the most advanced diabetes technology and always-on support when and how they need it. We've pioneered first-of-its-kind innovations for over 40 years and are committed to designing the future of diabetes management through next-generation sensors (CGM), intelligent dosing systems, and the power of data science and AI while always putting the customer experience at the forefront.
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary.
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Healthtech Security
Belong Health | January 10, 2024
Belong Health, a company dedicated to advancing patient-centered healthcare and reducing the cost of caring for underserved and complex populations, has announced the formation of
Belong Medical Group to help its plan and provider partners address chronic gaps in patient care.
Belong Medical Group supplements existing care infrastructure with virtual and community-based resources to care for every member – even those that are historically hard to reach. The team includes operators, clinicians, registered nurses, licensed clinical social workers and community health workers with extensive experience serving high-needs populations.
Operating as a separate unit within Belong Health, Belong Medical Group is a transitional care organization that develops clinical programming and wraparound services to help plan partners, providers and provider groups care for members with chronic conditions during changes in their care plans. This improves patient outcomes while reducing overall costs.
Bridging Gaps in Care
Dual-eligible members require more specialty care, particularly in the areas of behavioral health and palliative care. Patients with mental illness combined with one or more chronic conditions average three-times the medical spend compared to patients without mental illness. Almost 45% of dual-eligible patients fall into this category. Belong Medical Group was built to serve high-needs patients, including the 11 million D-SNP members with complex issues, low incomes and pre-existing conditions, to improve outcomes and reduce costs.
"The clinician shortage in the U.S. continues to worsen and existing care delivery models fail to meet the needs of patients, particularly those that are dually eligible,” said Belong Health CEO J. Patrick Foley. “Belong Medical Group is an innovative new model of care delivery that ensures the full integration of services, reduces fragmented care and drives operational efficiencies.”
By providing transitional care, Belong Medical Group helps plans serving D-SNP beneficiaries and providers participating in ACO REACH by
Bridging gaps in care through home-based and virtual specialty care services delivered by trusted members of Belong Medical Group’s Clinician and Care Management team.
Ensuring equitable access to care in urban and rural areas by meeting patients where they are.
Seamlessly integrating with the provider community to ensure that care is coordinated with their local provider for longitudinal care.
Mental Health Connector
Mental Health Connector is the first clinical solution available through Belong Medical Group. It serves patients without a current mental health provider or those with worsening chronic mental illness. These patients are identified during health risk assessments or hospital and ER admissions as having unmet mental health needs that require follow up. MVP Health Care, a regional not-for-profit health insurer serving New York and Vermont, is the first to offer Mental Health Connector to its members.
"Since the inception of our pilot program with Belong Medical Group, we have witnessed notable improvements in the depression scores of our members who have sought care from our dedicated Mental Health Connector clinicians,” said Dr. Carl Cameron, MVP Health Care’s Chief Medical Officer. “This heartening progress reinforces our belief that collaborative efforts can truly shape a brighter future for those with diverse health care needs. Belong Health and Belong Medical Group stand as trusted partners who share our unwavering dedication to providing high-quality care to a complex population. We value their expertise and their commitment to working hand-in-hand with us, ensuring that our members receive the comprehensive support they need.”
Patients enrolled in Mental Health Connector receive treatment from Belong Medical Group's clinicians for up to 90 days. The treatment plan put in place by Belong Medical Group’s psychiatrist or mental health specialist is then transitioned to either the patient's PCP for ongoing management, or to a longitudinal mental health clinician in the community. The goal is to both diagnose and address unmet mental health needs when patients need it most and then to triage the right level of care for the patient long-term once the issues are stabilized. This bridge to longitudinal care not only reduces the cost of care, it improves quality scores.
“These programs are essential. We need to meet patients where they are to help them better stick to their care plans during transitional phases,” said Dr. Ramon Jacobs-Shaw, President of Belong Medical Group and Chief Clinical Officer at Belong Health. “Too many people, especially seniors and dually eligible individuals, have needs that are not met by the existing care delivery landscape. Belong Medical Group provides smarter and more targeted services to those patients to make sure their needs are fulfilled, improving outcomes and overall community health.”
About Belong Health
Belong Health provides a new approach to health insurance by establishing deep partnerships with providers and insurers. This innovative model empowers us to address the unfulfilled requirements of underserved and complex needs populations in a more patient-centric way. Through fully risk-bearing partnerships, Belong Health helps insurers deliver products that provide more collaborative care to the MA and D-SNP population. Belong Health is also an accredited Accountable Care Organization, dedicated to delivering value-based care for Medicare FFS. Our mission is to offer more compassionate, collaborative and smarter healthcare solutions for underserved and complex needs populations.
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Medical Devices
Canon Medical Systems | January 15, 2024
Canon Medical Systems Corporation and Olympus Corporation announced that we have reached an agreement to collaborate on Endoscopic Ultrasound Systems. Canon Medical will develop and manufacture diagnostic ultrasound systems used in Endoscopic Ultrasonography1 (EUS), and Olympus will perform the sales and marketing efforts. The aim of this collaboration between Canon's Aplio i8002 diagnostic ultrasound system for EUS and Olympus' Ultrasound Endoscope3 is to provide the market with advanced EUS equipment capable of delivering high-quality image diagnoses. Canon Medical and Olympus are focusing on technological advancements and enhancing diagnostic performance in the EUS field, with plans for global expansion, starting in Japan and Europe.
Canon Medical has a history of more than 100 years in the diagnostic imaging systems business, including X-ray diagnostic systems, CT, MRI, and ultrasound diagnostic systems, and provides products and services to more than 150 countries and regions worldwide. Canon Medical has been a leading company in the development of diagnostic ultrasound systems since the 1960s and has pioneered the development of A-mode (Amplitude display mode) systems for neurosurgery and linear electronic scanning systems, among others. Canon Medical's strengths lie in its advanced ultrasound image quality and proprietary technologies, such as D-THI, an image quality enhancement technology, and SMI, an imaging technology that enables the delineation of extremely slow and fine blood flow, which has been difficult to image in the past.
Olympus has contributed to elevating the standard of care through early detection, diagnosis and staging, and minimally invasive treatment since developing the world’s first practical gastrocamera. In the field of EUS, Olympus has worked closely with physicians to develop new equipment to enhance imaging and diagnostic methods and expand procedures, helping gain and maintain a high share of the global market.
Through our collaboration, the two companies will achieve further qualitative improvements in the quality of images and performance in diagnosis and minimally invasive treatment of EUS, ultimately contributing to facilitate the early detection of diseases.
Comment from Toshio Takiguchi, President and CEO, Canon Medical Systems Corporation
“We have been promoting our business with diagnostic imaging at its core under the philosophy of 'Made for Life,' which expresses our desire to contribute to medical care that protects precious lives. We have a long history in diagnostic ultrasound systems and have developed unique technologies that contribute to the early detection of diseases in cooperation with doctors around the world. We are very pleased to collaborate with Olympus, a leading endoscope manufacturer, in the EUS field, which we have not been able to cover adequately until now, to deliver superior solutions to more patients.”
Comment from Frank Drewalowski, Executive Officer and Endoscopic Solutions Division Head, Olympus Corporation
“Olympus aims to improve patients’ quality of life through early diagnosis made available with Endoscopic Ultrasound Systems. In the field of EUS, diagnostic ultrasound systems are very important, and we are pleased to have a cooperative relationship with Canon Medical, which has advanced ultrasound imaging technology. Canon Medical and Olympus will continue to introduce products and technology that address the needs of the patients, healthcare professionals, and the broader medical industry.”
This examination uses ultrasound attached to the tip of an endoscope to observe the outer organs (pancreas, gallbladder, bile ducts, liver, etc.) from the stomach and duodenum. Compared to the approach from the body surface, the target organs can be observed at close range, allowing detailed diagnosis with clearer images. In the diagnosis of pancreatic cancer, EUS is recognized as having the same diagnostic capability as contrast-enhanced CT and MRI in the "Guidelines for Pancreatic Cancer Treatment (2022)" in Japan. EUS-FNA (Endoscopic Ultrasonography-FNA: a test to collect tumor cells using an ultrasound endoscope) enables qualitative tissue diagnosis by minimally invasive cell and tissue collection and is established worldwide as a diagnostic method when pancreatic cancer is suspected. In addition to endoscopic retrograde cholangiopancreatography (ERCP), which is the first choice for stent placement for obstructive jaundice, endoscopic ultrasound-assisted biliary drainage (EUS-BD) using the EUS-FNA technique is now available. With the advent of these devices, the endoscopic treatment area of Interventional EUS has been attracting increasing attention in recent years.
About Canon Medical Systems
Canon Medical offers a full range of diagnostic medical imaging solutions including CT, Diagnostic and Interventional X-ray, Ultrasound and MR, as well as a full suite of Healthcare IT solutions, across the globe. In line with our continued Made for Life philosophy, patients are at the heart of everything we do. Our mission is to provide medical professionals with solutions that support their efforts in contributing to the health and wellbeing of patients worldwide. Our goal is to deliver optimum health opportunities for patients through uncompromised performance, comfort and safety features.
At Canon Medical, we work hand in hand with our partners - our medical, academic and research community. We build relationships based on transparency, trust and respect. Together as one, we strive to create industry-leading solutions that deliver an enriched quality of life
About Olympus
At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states. For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.
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