Medtronic Launches World’s First and Only Infusion Set for Insulin Pumps that Doubles Wear Time up to 7 days in the US 

On November 15, 2022, Medtronic plc, a global leader in healthcare technology, announced the US launch of the Medtronic Extended infusion set, the first and only infusion set labeled for up to 7-day wear. To double the wear time of an infusion set, the Medtronic Extended infusion set employs advanced materials that help reduce insulin preservative loss while maintaining insulin flow and stability. 

The Medtronic Extended infusion set’s innovative design incorporates proprietary technology, such as a new tubing connector, which improves the physical and chemical stability of insulin, the reliability of infusion site performance, and the risk of infusion set occlusion. The adhesive patch also has a layer of adhesive that helps to extend wear time and provides comfort and durability for up to 7 days. Aside from the new infusion set, the Medtronic Extended reservoir is the only infusion set reservoir that has been tested and cleared to help keep insulin stable and safe for up to 7 days. 

Further, participants in clinical studies of the infusion set observed a 50% reduction in the number of times an infusion set needed to be changed, as well as a reduction in the number of infusion set failures associated with high glucose levels. Also, the study participants who used the Medtronic Extended infusion set reported that it was more comfortable to wear than their previous infusion sets and that the longer wear feature helped reduce the overall burden of insulin pump therapy.

Dr. Robert Vigersky, Chief Medical Officer, Medtronic Diabetes, said, “When patients first begin using a pump, doctors and other healthcare providers reinforce the need to change their infusion set every two to three days to limit the risk of infection and other safety concerns. For many people, this means scheduling life around infusion set changes, which may not be at the most convenient times ― turning around as you are headed out the door when you suddenly remember to change your infusion set or adding a few minutes to a tired child’s bedtime routine with an infusion set change.” Dr. Robert further added, “With the Medtronic Extended infusion set, these life interruptions are reduced with an innovation that doubles the wear.”

“Our goal is to make life easier for individuals living with diabetes and the Medtronic Extended infusion set helps us deliver on this with prolonged and more comfortable wear – something customers have been requesting for many years,” said Que Dallara, EVP & President, Medtronic Diabetes. She added, “We couldn’t be more pleased to launch this innovation during Diabetes Awareness Month when we take the time to reflect on what more we can do to alleviate the burden for those living with this chronic condition. We’re pleased to deliver a ground-breaking innovation that will make a real difference in the overall pump experience given the overwhelming and well-documented benefits of this therapeutic option.”

As per DelveInsight’s “Insulin Infusion Pumps Market” report, the global insulin infusion pumps market was valued at USD 6.48 billion in 2021, growing at a CAGR of 8.69% during the forecast period from 2022 to 2027 to reach USD 10.68 billion by 2027. The demand for insulin infusion pumps is expected to grow owing to the increase in the prevalence of diabetes mellitus, increasing sedentary lifestyle, growing aging population prone to diabetes, and growing focus on improving the safety and usability of insulin infusion pumps, among others, thereby contributing to the growth of the insulin infusion pumps market during the forecast period from 2022-2027. According to DelveInsight analysis, North America is expected to lead in revenue generation in the global insulin infusion pumps market owing to the large patient pool associated with diabetes mellitus and high consumer awareness regarding new product launches. 

Penumbra Launches First Hands-Free, Full Body Virtual Reality-Based Offering for Rehabilitation, Expanding REAL® System Platform

On November 15, 2022, Penumbra, Inc., a global healthcare company that designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet needs, announced the launch of its first full body, non-tethered immersive healthcare offering for rehabilitation. 

The REAL Immersive System is a platform of products that leverages virtual reality to deliver engaging, immersive healthcare designed to promote better health, including furthering functional skills, cognition, and stress management. The system is built on advanced technology with a growing library of VR-based activities and experiences. The REAL Immersive System platform comprises two product solutions: REAL y-Series for clinical rehabilitation and REAL i-Series for wellness.

The REAL y-Series product uses upper and lower body sensors that allow clinicians to track full body movement and progress in real time. The REAL System will be used to support a broad range of physical, cognitive, and mental well-being for patients undergoing physical or occupational therapy.

Further, the REAL y-Series can support an even broader range of conditions and levels of function, increasing utility for patients ranging from high acuity to high functioning. The REAL y-Series is being used in clinics and hospitals across the country to improve core and balance, cognition, functional uses, activities of daily living training (e.g., grocery shopping, self-care), and cognitive stimulation. 

“Two of the largest challenges in rehabilitation are maintaining patient motivation and lack of engagement,” said Gita Barry, executive vice president and general manager of Penumbra’s Immersive Healthcare business. She added, “Penumbra’s latest REAL y-series is the only hands-free, sensor-based VR platform available that provides activities for both the lower and upper body. By enabling patients to immerse and visualize their entire body in motion and providing clinicians the ability to individualize each therapy session to challenge and motivate patients, we can maximize the key benefits of rehabilitation therapy by promoting higher engagement and intensity, which has the potential to improve patient outcomes.”

“Penumbra is advancing the latest immersive healthcare technology to help patients get back to their life with as little impairment as quickly as possible. VR in healthcare can be an extraordinary resource in rehabilitation and with our full-body immersive innovation, we know we can have a tremendous impact on a broad range of patients,” continued Barry.

According to DelveInsight’s assessment, the rehabilitation equipment market is estimated to register positive revenue growth owing to factors such as the rising prevalence of chronic diseases such as arthritis, cancer, and others. Further, the increasing requirement for rehabilitation equipment among geriatric or bedridden patients or among traumatic injury patients will also propel the demand for rehabilitation equipment. Additionally, increasing access to the healthcare industry, surging strategic activities by key players, and others are anticipated to bolster the market, thereby contributing to the growth of the rehabilitation equipment market during the forecast period from 2022-2027. 

Genesis MedTech Group Receives FDA Approval for the Chocolate Touch® Drug-coated Balloon PTA Catheter 

On November 11, 2022, Genesis MedTech Group, a medical device company focusing on multi-therapy medical device products, announced that the Food and Drug Administration (FDA) had approved the Chocolate Touch® Drug-coated Balloon PTA Catheter. The product was developed by TriReme Medical LLC, a wholly owned subsidiary of QT Vascular Ltd, but in August 2020, the Gensis MedTech Group acquired the product from TriReme Medical LLC. 

The Chocolate Touch® drug-coated balloon is the first and only balloon catheter in the world that combines therapeutic agent delivery with a next-generation angioplasty platform for treating peripheral arterial disease. Chocolate Touch® uses pillow-like structures coated with a therapeutic agent to open in small sections. The chocolate touch catheter provides an alternative treatment to traditional drug-coated balloon angioplasty for patients suffering from peripheral arterial disease. 

The Chocolate Touch® Drug-coated Balloon PTA Catheter treats patients with peripheral artery disease in the superficial femoral artery and the popliteal artery. The company, Genesis MedTech Group, is planning to launch this product in the US through its subsidiary, G Vascular. 

Based on a randomized trial of patients with symptomatic femoropopliteal disease, the Chocolate Touch® drug-coated balloon (DCB) was shown to have statistically superior patency and non-inferior safety at 12 months when compared to the Lutonix® DCB.

The results of the trial were as follows: 

  • The Chocolate Touch showed statistical superiority in its primary efficacy endpoint of 12 months of True DCB Success, a measure of the target vessel remaining patent without the need for bail-out stenting. 
  • Primary patency was 78.8% for Chocolate Touch and 67.7% for Lutonix DCB at 12 months (psuperiority=0.0386). By Kaplan-Meier (KM) estimate, it was 83.3% for the Chocolate Touch and 73.0% for Lutonix DCB at 12 months.
  • The primary safety endpoint of 12-month freedom from major adverse events (MAE) was 88.9% for those treated with the Chocolate Touch versus 84.6% for Lutonix DCB (Pnon-inferiority <0.0001).
  • Chocolate Touch results reported the lowest all-cause KM mortality value as compared to reported mortality for FDA-approved DCBs in pivotal studies. Mortality rates for Chocolate Touch using KM estimates at 3 years were 6.7% for the Chocolate Touch and 11.1% for the Lutonix DCB.  

“This next-generation paclitaxel DCB is based on the Chocolate mechanism of pillow-and-groove formation resulting in an increased balloon surface facilitating effective drug release to the vessel wall and potentially reducing the need for permanent implants. The recently completed randomized, controlled study demonstrated excellent primary results, with statistically superior effectiveness as compared to the control drug-coated balloon. The Chocolate Touch is a drug-coated balloon category of its own,” commented Co-principal Investigator Professor Thomas Zeller, Universitaets-Herzzentrum, Bad Krozingen, Germany.

Warren Wang, Chairman and CEO of Genesis MedTech Group said, “The Chocolate Touch® FDA approval provides U.S. physicians and their patients a next-generation drug-coated balloon with exceptional safety and efficacy to use in treating patients with PAD. This approval demonstrates our commitment to bring innovation solutions to enhance the standard of care of millions of patients suffering from peripheral vascular diseases.”

According to DelveInsight’s “Balloon Catheters Market” report, the global balloon catheters market was valued at USD 4.60 billion in 2021, growing at a CAGR of 8.78% during the forecast period from 2022 to 2027, to reach USD 7.62 billion by 2027. The increase in the demand for balloon catheters is predominantly attributed to the growing prevalence of the geriatric population, as the elderly are more prone to cardiovascular disorders. Further, the increasing prevalence of hypertension, diabetes, obesity, arteriosclerosis and others are anticipated to spur the demand for balloon catheters in the market. Additionally, the increasing incidence of cancers in the pelvic region affecting the urinary system in varying capacities and technological advancements in product development, such as drug-coated balloon catheters and others, is anticipated to drive the global balloon catheters market during the forecast period from 2022 – 2027.

AEYE Health Received FDA Approval for AI-based Autonomous Screening for Referable Diabetic Retinopathy

On November 15, 2022, AEYE Health, a digital health company that provides fully autonomous, AI-based diagnostic screening solutions for retinal imaging with best-in-class clinical results and superior usability, announced that it received a 510(k) clearance from the U.S. Food & Drug Administration (FDA) to market its diagnostic screening system for diabetic retinopathy. 

The AEYE-DS is indicated for use with images obtained by Topcon NW-400, a leading desktop retinal camera. The technology’s accuracy, combined with the need to obtain only a single image per eye and the rare need to dilate, makes it a unique solution for use in primary care.

The FDA approval was based on pivotal Phase III study results which redefine both efficacy and usability of autonomous screening diagnostics in ophthalmology. The results stated that: 

  • The device has best-in-class clinical efficacy with 93% sensitivity and 91.4% specificity
  • The solution is recognized as the first and only solution that requires only a single image per eye, which shortens the screening process to one minute and increases its practicality and seamlessness
  • The device has best-in-class imageability, delivering a diagnostic result for over 99% of patients and rarely requiring dilation

“This is a huge step in revolutionizing diagnostic screening for diabetic retinopathy. AEYE’s technology delivers the first practical solution, as it features best-in-class efficacy alongside best-in-class usability, having the only one-image-per-eye solution and highest general and dilation-free imageability data,” said Zack Dvey-Aharon, Ph.D., CEO of AEYE Health. Zack added, “AEYE is still working to obtain clearance for the first and only diagnostic screening solution with a portable camera. We cannot be more excited to lead the innovation in this space with the goal of saving millions of people from losing their vision.”

Dr. Ianchulev, Professor of Ophthalmology at New York Eye and Ear of Mount Sinai and Board member of AEYE Health said, “The time has finally come for autonomous screening technology to exceed the efficacy of the human expert. The implications are that it can be practical for deployment on the front lines of population health – the primary care offices, where over 99% imageability and single image diagnostic acquisition are tantamount to market success”.

According to DelveInsight’s “Ophthalmic Imaging Equipment Market” report, the global ophthalmic imaging equipment market was valued at USD 2.33 billion in 2021, growing at a CAGR of 5.97% during the forecast period from 2022 to 2027, to reach USD 3.29 billion by 2027. The increase in demand for ophthalmic imaging equipment is predominantly attributed to the spike in the population suffering from diabetes and ocular disease. Further, the shifting focus towards developing technologically advanced products, the rising geriatric population base, and increasing image-guided surgeries are anticipated to drive the global ophthalmic imaging equipment market during the forthcoming years.

Alpheus Medical Treats First Patients in First-In-Human Clinical Trial for Novel High-Grade Glioma Brain Cancer Treatment

On November 10, 2022, Alpheus™ Medical, Inc., a privately held company developing a novel sonodynamic therapy (SDT) platform targeting solid body cancers, announced the treatment of the first three patients in the U.S.-based multi-center Phase I clinical trial evaluating the safety and optimal dosage of the company’s proprietary platform. 

Alpheus Medical’s investigational treatment included an innovative, non-invasive drug-device combination that targets cancer cells throughout the entire brain hemisphere using low-intensity, large-field ultrasound. The treatment can be done in an outpatient setting, allowing repeated treatment, and does not require the use of imaging, such as MRI.

The first-in-Human Phase I multi-center trial (NCT05362409) is designed to study the safety and optimal dosage of Alpheus’ SDT treatment and will enroll up to 33 patients. 

The trial is currently enrolling patients with high-grade gliomas, including glioblastomas, across three sites, including Northwell Health’s North Shore University Hospital (greater New York City, NY), Washington University in St. Louis (St. Louis, MO), and Dent Neurologic Institute (Buffalo, NY).

“Conventional therapy options for patients with high-grade glioma, including glioblastoma, are limited and innovation in the field has too long been stagnant, leaving patients with poor outcomes and significant trade-offs in quality of life. By non-invasively targeting and eradicating tumors through the entire brain hemisphere, Alpheus’ novel SDT platform represents a potential paradigm shift in the fight against this disease,” stated Michael Schulder, MD, Director of the Brain Tumor Center at Northwell Health’s Institute for Neurology and Neurosurgery. Schulder further added, “We are excited to be part of this important clinical trial and look forward to following these patients as we evaluate the therapy.”

“The heterogeneous, diffuse nature of gliomas behind the blood-brain-barrier (BBB) is preferably treated with a repeatable, large-field therapy that can extend beyond the borders of the visible tumor to eradicate the highly invasive cancer cells,” remarked Tanner M. Johanns, MD, Assistant Professor of Medical Oncology at Washington University School of Medicine in St. Louis. 

According to DelveInsight’s “Brain Monitoring Devices Market” report, the global brain monitoring devices market was valued at USD 6.31 billion in 2021, growing at a CAGR of 7.27% during the forecast period from 2022 to 2027 to reach USD 9.61 billion by 2027. The rise in demand for brain monitoring devices is predominantly attributed due to the increasing prevalence of various neurological disorders, technological advancements in the product, rising awareness about neurological disorders, and increasing applications of brain monitoring devices are further expected to boost brain monitoring devices. As per the Delveinsight analysis, North America is expected to have the fastest growth in revenue in the overall brain monitoring devices market during the forecast period. This is due to factors such as the increasing prevalence of neurological diseases, the growing geriatric population, and others that are expected to aid in the growth of the North American brain monitoring devices market.

Karidum Inc. Completes First-in-human Study of its Next Generation Globe® Pulsed Field System

On November 8, 2022,  Kardium Inc., a rapidly growing medical solutions company, announced the successful first-in-human study of its next-generation Globe® Pulsed Field System to treat atrial fibrillation (AF) using pulsed-field ablation (PFA) therapy.

The Kardium® team successfully treated 38 patients, isolating 100% of the patient’s pulmonary veins using the Globe Pulsed Field System. The Globe Pulsed Field (PF) System features the revolutionary Globe Catheter with 122 gold electrodes, each of which can map the patient’s cardiac anatomy and electrical activity and deliver PFA energy to the heart to treat atrial fibrillation. The Globe Catheter uses contact sensing to determine which electrodes are in contact with cardiac tissue to help ensure therapy is delivered effectively to the heart.

In this study, patients with paroxysmal AF received pulmonary vein isolation (PVI) treatment in as little as 16 minutes. Patients with persistent AF received PVI treatment, and then the Globe PF System was used to create a high-definition map of the entire atrium using real-time 3-D mapping capabilities. Using these maps, all of the patients with persistent AF received additional ablation of the posterior wall, and several patients also received a mitral isthmus line, all using the same Globe Catheter.

The company is now planning to conduct the study in the United States, Canada, Germany, and the Czech Republic. 

“PVI with the Globe PF System was very easy. I could quickly position the catheter in each pulmonary vein, ensure that the electrodes were in good contact, and then deliver pulsed field energy to isolate each vein safely and rapidly from one position,” said Dr. Vivek Reddy from Mount Sinai Hospital (New York, USA). He further added, “I also really liked the system’s flexibility in more complex cases. I could map the atrium and then deliver additional pulsed field lesions to isolate the posterior wall quickly and then create a mitral isthmus line.”

“The Globe PF System is designed to be a safe, effective, and rapid treatment for AF,” said Kevin Chaplin, CEO of Kardium. Chaplin commented, “We are extremely excited by these procedures, which demonstrate the flexibility and ease of use of the Globe PF System. Previous clinical cases with the Globe PF System have achieved 100% durable PV isolation three months after the procedure.”

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 USD4.63 billion by 2027. Factors such as the increasing prevalence of cardiovascular diseases such as cardiac arrhythmia, atrial fibrillation, and stroke. Further, growth in new therapies, technological advancements, increasing geriatric population, and others is expected to drive the overall cardiac ablation devices market during the forecast period of 2022-2027. Furthermore, as per the Delveinsight analysis, in the by-product type segment of cardiac ablation devices, radiofrequency ablators are expected to hold a significant share in the year 2021. This is primarily owing to the advantages offered by the segment. The radiofrequency ablators are minimally invasive, have excellent local tumor control, have promising long-term survival, and have a multimodal approach. Thus, the aforementioned factors will propel the demand for the radiofrequency ablator’s category in the upcoming years.