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Sep 15, 2022
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On September 12, 2022, Johnson & Johnson Vision, a part of Johnson & Johnson and a global leader in the eyecare market, had announced the launch of its newest innovation, ACUVUE® OASYS MAX 1-Day and ACUVUE® OASYS MAX 1-Day MULTIFOCAL contact lenses for the correction of presbyopia.
For people with presbyopia, ACUVUE® MAX 1-Day MULTIFOCAL contact lenses offer all-day comfort as well as sharp, clear vision at all distances and in all lighting conditions. For exceptionally effortless vision, the lenses combine the same two potent technologies—TearStableTM Technology and the OptiBlueTM light filter—plus PUPIL OPTIMIZED DESIGN technology, which tailors 100% of parameters to pupil size variations across age and refraction compared to less than 2% for the leading competitor.
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The TearStableTM Technology is intended to maximize tear-film stability and lock in moisture for exceptional all-day comfort. The OptiBlueTM light filter has the highest level blue-violet filter in the industry at 60%, to reduce light scatter for exceptional visual clarity, day to night. Additionally, ACUVUE® OASYS MAX 1-Day lenses block 99.9% UVA rays and 100% UVB rays.
Moreover, in the clinical trials of ACUVUE® OASYS MAX 1-Day, 90% of wearers reported all-day comfort and a reduction in tired eyes from digital devices, with nearly 100% reporting clear, reliable vision. ACUVUE® OASYS MAX 1-Day builds on the ACUVUE® OASYS portfolio of products, which is unmatched in comfort across 31 clinical trials.
For its most recent contact lens innovation, ACUVUE® OASYS MAX 1-Day and ACUVUE® OASYS MAX 1-Day MULTIFOCAL earned approval from the U.S. Food & Drug Administration (FDA), Health Canada, and completed CE Mark activities earlier this year.
John Buch, OD, Senior Principal Research Optometrist, Johnson & Johnson Vision, said, “Our new ACUVUE® OASYS MAX 1-Day contact lenses help reduce discomfort by providing visual clarity with new technologies to filter blue-violet light which comes from many sources, including digital screens and travels in short wavelengths and scatters more which can lead to eye discomfort and quality of vision.” He further added that “Life has changed, post-pandemic. With more time spent on digital devices, we designed these contact lenses by listening to patients and eye care professionals’ feedback to address lifestyle requirements and help prevent dry and tired eyes from becoming normalized.”
“It’s important for all contact lens users to have the latest innovative treatment options available to help address comfort and clarity to meet their lifestyle requirements. ACUVUE® OASYS MAX 1-Day uses innovative technology, designed to maximize tear film stability and reduce light scatter to maintain increased visual clarity and all-day comfort.” said Luis Rojas, OD, co-founder of DeNovo Eye.
As per DelveInsight’s “Contact Lenses Market” report, the global contact lenses market was valued at USD 9,974.25 million in 2021, growing at a CAGR of 5.14% during the forecast period from 2022 to 2027 to reach USD 13,436.70 million by 2027. The demand for contact lenses is expected to grow owing to an increase in ophthalmic diseases such as myopia, presbyopia, and astigmatism, among others, the rising geriatric population which is susceptible to presbyopia, increasing sedentary lifestyle as well as screen time, and the growing focus on improving the safety and usability of contact lenses for end users, thereby contributing in the growth of the contact lenses market during the forecast period from 2022-2027.
On September 8, 2022, Aerin Medical Inc., a company that provides Ear, Nose, and Throat (ENT) physicians with non-invasive remedies for treating chronic nasal conditions, announced the U.S. Food and Drug Administration (FDA) 510(k) clearance and launch of a next-generation product RhinAer® stylus.
Runny nose, congestion, itching, sneezing, coughing, and post-nasal drip are just a few of the symptoms of rhinitis or inflammation of the mucous membrane of the nose. When symptoms of rhinitis persist for more than four weeks straight, it can be difficult to find a cure. With RhinAer, the stylus is placed inside the nasal airway to directly cut off nerve signals and assist in easing the symptoms of chronic rhinitis.
RhinAer uses non-invasive, temperature-controlled radiofrequency technology to effectively address the underlying causes of rhinorrhea (runny nose), post-nasal drip, and congestion brought on by chronic rhinitis, in a single session. The new RhinAer is made to give doctors better visibility, simpler access, and tissue apposition, particularly in patients with constrictive nasal airways.
RhinAer has been clinically shown in numerous studies to effectively alleviate the symptoms of chronic rhinitis. 88.2% of patients had a good response to RhinAer treatment after 24 months, as determined by a 30% improvement in chronic rhinitis symptoms from baseline, according to recent long-term clinical research.
Aerin Medical and otolaryngologists worked closely together to develop the new RhinAer, which has a number of improvements in order to make the tool more user-friendly. To enhance vision and accessibility, RhinAer updated its new lower-profile stylus by giving it a smaller shaft and tip. Additionally, the shaft is more pliable, and the tip now tilts 10 degrees backward, allowing for simpler tissue apposition during procedures.
“The new RhinAer stylus gives me confidence that I can access and treat the posterior nasal nerve area more effectively. This newer generation RhinAer allows me to confidently treat multiple target areas, in the office setting, even in very challenging anatomy.” said Dr. Randall Ow, otolaryngologist at Sutter Health in Sacramento and the first physician in the world to use the device on a patient.
Matt Brokaw, CEO of Aerin Medical said, “We listened closely to the otolaryngology community in developing the new RhinAer and based upon our discussions, rigorous testing and physician feedback, we are confident that the next-generation RhinAer stylus enhancements will be well-received.”
According to DelveInsight’s “ENT Devices Market” report, the global ENT devices market was valued at USD 16.80 billion in 2021, growing at a CAGR of 6.89% during the forecast period from 2022 to 2027, in order to reach USD 25.02 billion by 2027. The ENT devices market is estimated to register positive revenue growth owing to factors such as the rising prevalence of hearing loss across the globe coupled with the rising prevalence of various ear, nose and throat problems as a result of viral and bacterial infections, growing geriatric population, chronic diseases like cancer, allergic rhinitis, and others will propel the market for ENT devices during the forecast period.
On September 12, 2022, Corindus, a part of Seimens Healthineers company and a key market player in the field of precision vascular robotics, presented the study results of CorPath GRX Neurovascular System, demonstrating its safety and effectiveness in neurovascular aneurysm embolization.
The robotic-assisted neurovascular aneurysm embolization trial is the first of its kind in the world. It is prospective, single-arm, multinational, multi-center, and non-inferiority.
117 participants from 10 clinical sites across six nations were involved in the study. Additionally, it contained a wide variety of aneurysms, which represented a varied group of instances with various locations, diameters, and morphological traits. The hospitals that treated the trial participants will continue to follow them for 180 days in order to track additional, long-term outcomes.
Study Results:
The CorPath GRX System is the first medical device for percutaneous coronary and vascular treatments to be FDA-cleared and CE Marked. Healthcare facilities outside of the United States currently use the platform for neurovascular interventions because it has received the CE Mark for neurovascular procedures.
” The results of the study show the CorPath GRX System helps physicians move efficiently within tortuous and unstable.” said Michel Piotin, Principal Investigator, MD, Ph.D., Head of the Interventional Neuroradiology Department at the Rothschild Foundation Hospital in Paris.
“The work of our clinical partners on this study marks an early step toward truly transformative change in neurovascular intervention.” said Dr. Raymond Turner, Chief Medical Officer, Neuroendovascular at Corindus. He further added, “By incorporating robotic platforms in this space, we are paving the way for remote interventional procedures in the future that will connect patients to specialized interventionalists for treatment, regardless of location. Validating clinical evidence, such as this study, will serve as the foundation for that transformation.”
According to DelveInsight’s “Neurovascular Devices Market” report,” the global neurovascular devices market was valued at USD 2.84 billion in 2021, growing at a CAGR of 8.12% during the forecast period from 2022 to 2027, to reach USD 4.53 billion by 2027. The increase in demand for neurovascular devices is predominantly attributed to the spike in the population suffering from neurological disorders and the shifting focus towards developing technologically advanced products, which is thereby anticipated to drive the global neurovascular devices market during the forthcoming years.
On September 14, 2022, Olympus, a global leader in the endoscopy market, announced the launch of VISERA ELITE III, which is a creative and open approach combining several observational techniques for endoscopic surgery.
The VISERA ELITE III system combines the 4K imaging function from the VISERA 4K UHD system with the 3D and infrared imaging functions from the VISERA ELITE II system. It also supports NBI, an original observation mode created by Olympus, as well as fluorescence-guided surgery.
The all-in-one system promotes consistency and boosts productivity in the operating room by giving surgeons a variety of viewing modes. On VISERA ELITE III, users can also create personalized departmental profiles for various medical specialties, including general surgery, urology, gynecology, ENT surgery, and more. The platform works with VISERA ELITE II endoscopes that are currently in use.
With its EDOF (Extended Depth of Field) feature and focus-adjustment mode for 4K surgical observation, the VISERA ELITE III system enables accurate endoscopic observations through continuous broad focus and seamless magnification.
Additionally, it has the C-AF (Continuous Auto Focus) feature, which automatically changes focus in response to the movements of the endoscope and camera head. This enables crisper image capture from a distance as well as up close, reducing the stress experienced by HCPs during surgery and allowing them to focus on the patient and the result of the procedure.
Future software updates will advance surgical imaging technology and enable customized configurations that simplify the seamless integration of multiple surgical applications, lowering investment costs.
Kanichi Matsumoto, Global Head of Surgical Endoscopy at Olympus, said, “With VISERA ELITE III, we provide a best-in-class surgical visualization platform designed for multiple medical specialties and configurations, allowing HCPs to fully focus on the patient during surgery. By incorporating the technologies of its predecessors VISERA ELITE II and VISERA 4K UHD into one platform, VISERA ELITE III enhances the quality of endoscopic surgery, contributes to improved efficiency in the operating room, and hereby elevates the standard of care.”
According to DelveInsight’s “Endoscopes Market” report, the global endoscopes market was valued at USD 12.95 billion in 2021, growing at a CAGR of 6.05% during the forecast period from 2022 to 2027 to reach USD 18.32 billion by 2027. The growing demand for endoscopes is primarily associated with the rising prevalence of chronic disorders, which require endoscopes and an increase in the early diagnosis and treatment of various cancers and some chronic diseases, thereby propelling the market growth of endoscopes during the forecast period.
On September 12, 2022, Haemonetics, a global medical technology company providing innovative medical solutions to improve patient outcomes, announced that its VASCADE® vascular closure and VASCADE MVP® venous vascular closure systems had received CE mark certification.
The CE marking will enable Haemonetics to take the following actions necessary for the entry of both goods into the European Union (EU) on a country-by-country basis and serves as the foundation for entry into other regions that accept the CE marking.
The VASCADE system, which is typically utilized in interventional cardiology and peripheral vascular treatments, is created for “small-bore” femoral arterial and venous closure. The VASCADE MVP system is the only FDA-approved closure device for use during cardiac ablation operations requiring two or more access sites inside the same limb.
It is designed for “mid-bore” multi-access femoral venous closure, which is typically utilized in electrophysiological procedures. Both devices use a resorbable collagen patch and a patented collapsible disc technology to achieve hemostasis.
VASCADE and VASCADE MVP are made to help patients establish hemostasis more quickly and with an average of fewer problems while also saving time for medical staff.
“We see a significant opportunity to bring the advantages of our unique Vascular Closure products to hospitals within the EU, and look forward to taking steps towards commercializing in the market. With the VASCADE portfolio earning CE Mark certification, we can meaningfully improve hospital operations throughout the region and further our goal of raising the standard of care for patients around the globe.” said Stew Strong, President, Global Hospital at Haemonetics.
According to DelveInsight’s “Vascular Closure Devices Market” report, the global vascular closure devices market was valued at USD 1.11 billion in 2021, growing at a CAGR of 6.18% during the forecast period from 2022 to 2027, to reach USD 1.59 billion by 2027. The demand for vascular closure devices is motivated by a rise in the prevalence of cardiovascular diseases like cardiac arrhythmia, atrial fibrillation, and heart strokes. Further, the growth in the geriatric population, obesity, hypertension, and surge in the number of minimally invasive procedures during the forecast period are expected to drive the market for vascular closure devices.
On September 13, 2022, GE Healthcare, a part of GE and a global leader in medical technology, pharmaceutical diagnostics, and digital solutions innovator, found that [18F]flurpiridaz PET Radiotracer could improve the detection of coronary artery disease along with Lantheus, a company committed to improving patient outcomes through diagnostics, radiotherapeutics, and artificial intelligence solutions.
The investigational radiotracer, [18F]flurpiridaz, underwent a recent Phase III clinical trial, and the results showed that it exceeded the 60 percent threshold for both sensitivity and specificity for identifying coronary artery disease (CAD).
With invasive coronary angiography serving as the gold standard of accuracy, the Phase III Open-Label Study, which included more than 600 patients at sites in the United States, Europe, and Canada, evaluated the diagnostic effectiveness of [18F]flurpiridaz in identifying CAD, the most prevalent form of heart disease and the world’s leading cause of death.
Additionally, it showed that, when compared to Single Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI), the main nuclear cardiology procedure, [18F] flurpiridaz Positron Emission Tomography (PET) has higher diagnostic efficacy and image quality in patients with suspected CAD.
If approved, this experimental agent would have the same benefits of 18F, including widespread availability, a half-life of over two hours, and the elimination of the necessity for it to be produced nearby the imaging department. Due to its longer half-life, Flurpiridaz (18F) Injection may also be useful for exercise stress testing, which is not possible with the cardiac PET radiotracers that are currently available.
“The positive Phase III trial results are a key step towards future approval of Flurpiridaz (18F) Injection as a potential new cardiac PET agent which could improve the detection of coronary artery disease.” said Dr. Francois Tranquart, MD, Ph.D., Global Head of Clinical Development for GE Healthcare Pharmaceutical Diagnostics, Research, and Development.
“These results are truly promising for the nuclear cardiology community and CAD patients. From ASNC’s inception, its leaders have laid out the specifications for an ideal myocardial perfusion tracer. In my view [18F]flurpiridaz could meet this goal, expanding how PET MPI can be used to image CAD patients moving forward.” said Dr. Tim Bateman, MD, FACC, co-director of the Cardiovascular Radiologic Imaging Program at Saint Luke’s Hospital, Missouri, US.
According to DelveInsight’s “Coronary Stents Market” report, the global coronary stents market was valued at USD 9.27 billion in 2021, growing at a CAGR of 7.51% during the forecast period from 2022 to 2027, to reach USD 14.28 billion by 2027. Factors such as the increasing prevalence of cardiovascular disorders such as stroke, atherosclerosis, heart attacks, and others, the rising geriatric population, increasing demand for minimally invasive surgeries, technological advancements, and others are expected to drive the overall coronary stents market during the forecast period of 2022-2027.
On September 05, 2022, Pulmonx Corporation, experts in minimally invasive treatments for severe lung disease, announced the results of preliminary findings from the CONVERT study.
Data from the study’s first 40 patients showed that 78% of those who had subsequent therapy with Zephyr Valves after receiving the AeriSeal System had their collateral ventilation (CV) status successfully converted.
The AeriSeal System makes the patient having severe cases of chronic obstructive pulmonary disease (COPD)/emphysema eligible to undergo Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Valves by closing collateral air channels in a target lung lobe. Zephyr Valves are suitable treatment options for patients having untreated collateral ventilation (CV+) in their lungs. Zephyr valves are found to be effective in patients with COPD/emphysema by improving lung function, quality of life, and exercise capacity and can be used to treat patients once the target lobe is converted from CV+ to CV-.
The AeriSeal System is used in the CONVERT research to stop collateral airflow. Zephr valves are placed to address hyperinflation of the target lobe once the treated lobe tests negative for CV-, easing emphysema symptoms without significant surgery. Zephyr Valves lead to a mean reduction in Target Lobe Volume Reduction (TLVR) of more than one liter.
The clinical results of Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Valves have not been released because the CONVERT Study is still in progress. However, the AeriSystem successfully closed collateral air channels and enabled successful clinical outcomes after treatment with Zephyr Valves, according to the recent findings from a single-center feasibility study at Macquarie University Hospital in Australia.
At 6 months, AeriSeal and Zephyr Valve treated CV+ patients experienced clinically meaningful improvements similar to improvements in CV- patients treated with Zephyr Valves alone.
The improvements witnessed were:
In the Australian feasibility study, no patients reported major adverse reactions; 20% of patients in the CONVERT Study had an inflammatory response after receiving AeriSeal; all of these reactions were temporary, were treated medically. According to the information that is currently available, patients who have collateral ventilation can successfully undergo BLVR with Zephyr Valves following closure of the fissure gap with the AeriSeal System.
“This work reflects our continued commitment to developing and testing new medical technologies to help patients with severe lung disease breathe easier and have better quality of life,” states Glen French, President and Chief Executive Officer of Pulmonx. He added, “These early study results are encouraging and move us closer to the goal of helping severe emphysema patients who have collateral ventilation benefit from our proven Zephyr Valve treatment.”
As per DelveInsight’s “Chronic Obstructive Pulmonary Disease (COPD) Treatment Devices Market” report, the global COPD treatment devices market is expected to grow at a CAGR of 6.37% during the forecast period from 2022 to 2027. The demand for COPD treatment devices is primarily being boosted by the increasing prevalence of COPD, rising exposure to air pollution, chemicals, dust, and others, the increasing geriatric population across the globe, the rise in tobacco consumption among youth, and the rising technological advancements are expected to cause an increase in the COPD treatment devices demand thereby contributing in the growth of the COPD treatment devices market during the forecast period from 2022-2027.
On September 06, 2022, GlucoRx and Cardiff University announced the development of the first multi-sensor non-invasive continuous glucose monitor (CGM), which will be a milestone in the treatment of diabetic patients without the use of needles.
Based upon radio frequency technology and a multiple sensor approach GlucoRx BioXensor™ measures blood glucose levels accurately in a minimally invasive manner.
Patients with diabetes have to endure painful finger pricks in order to obtain blood for testing using glucometers or use semi-invasive devices like continuous blood glucose monitors (CGMs). Contrarily, the GlucoRx BioXensorTM requires no finger pricking and is a painless, accurate, long-lasting, and economical alternative to blood glucose monitoring. It is capable of measuring blood sugar levels between 3 and 30 mmol/l.
By aiding in diabetes prevention or its remission, GlucoRx BioXensorTM may improve the way diabetic patients live. Additionally, it has technologies for remote monitoring and smart alarms.
Chris Chapman, GlucoRx Chief Operating Officer, said: “We are exciting about this life-changing end-to-end diabetes monitoring platform of ours which can be discreetly stuck on the skin to monitor blood glucose, giving readings every minute on smart mobile applications.” He further added, “GlucoRx BioXensor™ has standout accuracy owing to its multi sensor approach capturing blood glucose as well as Sp02, ECG, respiration rate, heart rate, temperature, activity, sleep, and early fall detection. The wearable device has a longer shelf-life because it is not chemical in its action.”
According to DelveInsight’s “Blood Glucose Monitoring Systems Market” report, the global blood glucose monitoring systems market was valued at USD 13.06 billion in 2021, growing at a CAGR of 7.72% during the forecast period from 2022 to 2027, to reach USD 20.40 billion by 2027. The blood glucose monitoring systems market is estimated to register positive revenue growth owing to the factors such as the rising prevalence of diabetes globally coupled with the rising geriatric population. Moreover, rising government initiatives for diabetes, and the increasing focus of manufacturers on developing technologically advanced blood glucose monitoring systems, are likely to propel the market of blood glucose monitoring systems in the upcoming years.
On September 06, 2022, AtriAN Medical Ltd., a medical device company, announced that the enrolment in a second study using their selective pulsed field ablation (PFA) method to treat atrial fibrillation had been completed.
The Neural AF-2 trial, which uses AtriAN’s special cardiac autonomic ablation technology to selectively ablate neural regions on the exterior of the heart, has included cardiothoracic surgery patients with paroxysmal AF. The Tbilisi Heart and Vascular Clinic in Georgia treated a total of 12 patients, with Prof. Tamaz Shaburishvili serving as the principal investigator. Patients will be monitored for the recurrence of AF for a full year.
The new study expands upon AtriAN’s initial Neural-AF study, which examined 24 patients undergoing concurrent coronary artery bypass grafting and focused on safety, feasibility, and acute outcomes. The initial research was conducted at the Tbilisi Heart and Vascular Clinic and the Na Homolce Hospital in Prague, Czech Republic (Georgia). Both Prof. Joris de Groot (Amsterdam UMC) and Prof. Vivek Reddy MD (Mount Sinai Hospital, NY) presented data from the study in conferences hosted by the European Heart Rhythm Association (EHRA) in 2022.
The original Neural-AF study had an open enrollment policy for CABG patients and did not have a dedicated atrial fibrillation subgroup. The results show that safe and practicable selective epicardial PFA of ganglionated plexi, acute atrial tissue extension.
“The promising results from our first study have given us the confidence and momentum to expand into this second trial looking specifically at clinical outcomes in patients with AF” said AtriAN CEO Ken Coffey. He added, “This will be a challenging cohort of patients but we look forward to providing them with improved outcomes and demonstrating the potential of our novel approach.”
According to DelveInsight’s “Cardiac Ablation Devices Market” report, the global cardiac ablation devices market was valued at USD 2.25 billion in 2021, growing at a CAGR of 12.77% during the forecast period from 2022 to 2027 to reach USD 4.63 billion by 2027. The increasing demand for cardiac ablation devices is primarily associated with the growing number of cardiac diseases such as stroke, cardiac arrhythmia, and others, the integration of advanced technology, increasing investments by government and private manufacturers, and the rising awareness programs regarding cardiovascular disorders, and increasing geriatric population, among others. As per DelveInsight’s Analysis, in the cardiac ablation devices market by technology, radiofrequency ablators is expected to hold the largest share in the market owing to various advantages associated with it, including low cost, ease of use, multimodal approach, and minimally invasive feature among others.
On August 31, 2022, Medtronic plc, a global leader in healthcare technology, announced the strategic partnership with BioIntelliSense a health monitoring and clinical intelligence company, to gain distribution rights of BioButton® multi-parameter wearable in US hospitals.
This partnership allows Medtronic’s Patient Monitoring business to offer BioButton® wearable devices for continuous monitoring of vital signs in general care patients in-hospital and post-discharge. The partnership aims to simplify the care delivery process through workflow automation, enabling proactive clinical intervention and helping to address the implications of staffing shortages.
Up to 1,440 vital sign measures each day, including resting heart rate, breathing rate, and skin temperature, can be evaluated using the BioButton device used for patient monitoring. The device’s customizable acute and post-acute modes allow it to be used to monitor patients as they move from higher to lower acuity settings. It is rechargeable. It helps professionals distinguish between stable patients and people with diseases thanks to an integrated advanced analytics function.
“Our vision is to empower clinicians and patients with actionable insights to personalize care — anytime, anywhere,” commented Frank Chan, Ph.D., president of the Patient Monitoring business, which is part of the Medical Surgical Portfolio at Medtronic. He added, “Today, our solutions touch more than 100 million patients annually in hospitals. Through our collaboration with BioIntelliSense, we will support continuous, connected care from in-hospital to home and expand our reach to help more patients in more places than ever before.”
“In partnership with Medtronic, we are poised to accelerate continuous connected care models that offer a new level of clinical surveillance and workflow efficiencies for hospitals that are challenged in today’s environment of growing workforce shortages and cost of care management,” remarked James Mault, M.D., founder and CEO of BioIntelliSense. He added, “This advanced remote physiologic monitoring simplifies care delivery to facilitate personalized patient care, clinical workflow automation, and proactive clinical interventions.”According to DelveInsight’s “Wearable Medical Devices Market” report, the global wearable medical device market is estimated to grow at a CAGR of 13.67% during the forecast period from 2022 to 2027. Factors such as the increasing incidence of chronic diseases, increasing geriatric population, rising awareness on health and fitness, increasing regulatory approval activities for wearable medical devices, and others are expected to bolster the demand for these services during the forecast period. As per DelveInsight’s study, among all the regions, North America is expected to hold the highest market share. This is primarily attributed to the rising prevalence of chronic diseases in the region and the increasing product launches in the wearable medical devices market.
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