B. Braun Launched Introcan Safety® 2 IV Catheter with Multi-Access Blood Control Designed to Protect Clinicians Every Time the Hub is Accessed

On October 11, 2023, B. Braun Medical Inc. (B. Braun), a leader in smart infusion therapy, announced the launch of its new Introcan Safety® 2 IV Catheter with Multi-Access Blood Control. 

The most recent addition to B. Braun’s extensive range of passive needlestick avoidance catheters is the Introcan Safety 2 IV Catheter. Every time the hub is accessed, a blood control mechanism shields clinicians from blood exposure in addition to automatic needlestick protection. Lowering the chance of coming into contact with bloodborne pathogens during the IV procedure.

An essential component of infusion therapy is IV access, and needlestick injuries are still a major danger that doctors must deal with regularly, putting them at risk for exposure to bloodborne infections. Research indicates that fully automatic, passive safety devices reduce needlestick injuries three times better than manually sliding shields and twice as well as semi-automatic “push button” safety shields. A fully automatic passive safety device protects clinicians with the Introcan Safety 2 Catheter.

Blood exposure on the mucocutaneous layer as a result of catheter hub spillage is a hazard in addition to needlestick injuries. It has been demonstrated that blood-control IV catheters greatly lower the risk of blood exposure and the cleaning effort involved. Furthermore, a survey’s findings suggest that the time and materials needed for blood cleanup could be less expensive. The multi-access blood control function of the new Introcan Safety 2 Catheter operates numerous times, assisting in minimizing blood exposure and spillage throughout the IV procedure.

“Appropriate device selection is key to achieving successful PIVC outcomes,” said Chad Laity, Director of Marketing, Vascular Access, IV Systems and Securement. Chad added, “The newly launched Introcan Safety 2 IV Catheter with Multi-Access Blood Control provides clinicians with another option when choosing the right device for their patients. When combined with our Peripheral Advantage® Program, our technology and solutions are designed to facilitate the best possible outcomes around vascular access care.”

As per DelveInsight’s “Peripherally Inserted Central Catheter Devices Market” report, the Peripherally Inserted Central Catheter (PICC) Devices market was valued at USD 976.13 million in 2022, growing at a CAGR of 5.29% during the forecast period from 2023 to 2028 to reach USD 1,326.59 million by 2028. The demand for peripherally inserted central catheter devices is primarily being boosted owing to key factors such as the increasing incidence of cancers, and infectious diseases, among others, technological advancements in product portfolio, and proper reimbursement coupled with increasing product launches, thus creating a positive market growth for the Peripherally Inserted Central Catheter (PICC) Devices market during the forecast period from 2023-2028.

Everly Health Launched Comprehensive At-Home Collection Kidney Health Test to Address Chronic Kidney Disease 

On October 5, 2023, Everly Health, a digital health company at the forefront of remote diagnostics-driven care, launched a comprehensive at-home collection kidney health test for health plans and employers to expand access to prevention, diagnosis, and treatment of chronic kidney disease (CKD).

The Everly Health At-Home Collection Kidney Health Test combines the estimation of kidney function through blood collection, estimated glomerular filtration rate (eGFR), and kidney function assessment through urine collection using the urinary albumin-to-creatinine ratio (UACR). Everly Health ensures that tests reach or surpass the accuracy of conventional laboratory tests by using cutting-edge technology and processing samples at labs approved by CAP and CLIA. When compared to normal collection procedures, the Everly Health Kidney Health Test collection methods have a correlation of above 98.6%.

By facilitating testing and meeting the 2024 KED HEDIS measure, the kidney health test with at-home collection seeks to reduce lifetime expenses related to diabetes and Chronic Kidney Disease.

According to Everly Health data, Medicare costs related to chronic kidney disease (CKD) may be lowered by 74%, or USD 63.2 billion, if kidney illness is detected early. Everly Health’s diagnostics-driven remote care model makes it simple to improve health outcomes at significantly lower costs to both patient and provider, as health plans strive to close Healthcare Effectiveness Data and Information Set (HEDIS) measures and raise The Centers for Medicare & Medicaid Services (CMS) Star Ratings.

With the help of Everly Health’s in-house technology platform, health plan administrators can easily and digitally monitor the whole duration of preventative screening programs, from reporting to monitoring. The procedure is straightforward for patients: they simply pick up their user-friendly at-home test kit, gather a sample, and return it in a pre-paid envelope.

Electronically sent test results, shipment and processing updates, and warnings of any possible anomalies are sent to participants. If necessary, participants also receive practical next actions from a healthcare professional. 

“Kidney disease affects 37 million adults in the United States but 90% are unaware they even have it which makes it a silent killer,” said Dr. Liz Kwo, MD, MPH, MBA, Everly Health Solutions Chief Commercial Officer. Dr. Liz added, “We have an opportunity to significantly change the course of chronic kidney disease in the United States by working to ensure early detection is available to people through the testing they need to protect their kidney health.”

According to DelveInsight’s “Chronic Kidney Disease Market” report, the Chronic Kidney Disease Market is expected to grow at a CAGR of 6.6% during the forecast period from 2023 to 2028. Factors such as increasing incidences of chronic kidney disease, technological advancements in diagnostic tests for kidney diseases, and the increasing need for early detection are promoting market growth.

Sanguina Announced US FDA Clearance for AnemoCheck Home

On October 4, 2023, Sanguina, Inc. (Sanguina), a leading biotech company, announced the US Food and Drug Administration (FDA) clearance of AnemoCheck Home, the only FDA-cleared home hemoglobin test kit available in the United States.

With the revolutionary AnemoCheck Home test, people with anemia caused by nutritional deficiencies (such as iron, vitamin B12, or folate deficiency), sickle cell disease, or thalassemia can now easily check their hemoglobin levels in the comfort of their own homes. The test is an in vitro diagnostic tool that can only be obtained with a prescription, guaranteeing proper medical supervision and direction.

With AnemoCheck Home, users may perform a quick fingerstick blood test to acquire precise hemoglobin level readings. The user sticks their finger, draws blood into a sample collecting tube, and then attaches the test body to the test cap. After that, the test is shaken to mix the blood. The color on a color card corresponds to the hemoglobin level after two minutes. There is no need for any additional equipment, and the test is disposable.

By utilizing the most recent developments in medical technology, AnemoCheck Home guarantees accurate and dependable findings, giving consumers the ability to take charge of their anemia treatment. 

Easy-to-follow instructions and all necessary supplies are included in the kit to ensure a safe and effective fingerstick test.

Erika Tyburski, CEO of Sanguina commented, “Our team at Sanguina is proud to introduce AnemoCheck Home as a game-changer for at-home anemia testing. With this FDA clearance, we are excited to provide people who have anemia with a convenient, accurate, and accessible tool to monitor their hemoglobin levels at home.”

According to DelveInsight’s “Hemoglobin Testing Market Insights and Competitive Landscape” report, the global hemoglobin testing market is estimated to grow at a CAGR of 7.10% during the forecast period from 2023 to 2028. The rising prevalence of chronic diseases such as anemia and diabetes is boosting the global hemoglobulin testing market. Furthermore, factors such as good reimbursement for hemoglobin testing under various health insurance policies are catalyzing market expansion. Furthermore, factors such as improved health infrastructure, rising per capita healthcare expenditure, rising awareness for blood-related disorders, an aging population, technological improvements, and so on are expected to boost the global hemoglobin testing market in the approaching years.

DePuy Synthes Received US FDA Clearance for the TriALTIS™ Spine System and Navigation Enabled Instruments 

On October 9, 2023, Johnson & Johnson MedTech announced that DePuy Synthes, The Orthopaedics Company of Johnson & Johnson secured 510(k) clearances from the U.S. Food and Drug Administration (FDA) for the TriALTIS™ Spine System and TriALTIS™ Navigation Enabled Instruments.

With its superior instrumentation and complete implant portfolio, the TriALTIS™ Spine System is a next-generation posterior thoracolumbar pedicle screw system that can be integrated with supporting technologies.

Drills, taps, and screwdrivers that may be used manually or with power for both navigated and non-navigated applications are examples of TriALTIS™ Navigation Enabled Instruments.

The TriALTIS™ Spine System combines a revolutionary implant portfolio with a digital environment to meet unmet clinical needs and assist surgeons in treating complicated spine disorders, such as degenerative, tumor, trauma, and deformity pathologies, with more consistent outcomes.

With a primary focus on performance and a consistent user experience, the TriALTIS™ Spine System was designed, building upon a tradition of dependable thoracolumbar solutions and knowledge. The TriALTIS™ Spine System’s forward-thinking and inclusive design philosophy allows for seamless integration with robotically assisted solutions, power, navigation, and cement augmentation.

According to DePuy Synthes, the TriALTIS™ Spine System will be accessible in the United States by 2024.

“When it comes to treating complex spinal pathologies, each patient is different, and each case requires its own unique treatment decisions,” said Daniel Sciubba, MD, MBA, and Chair & Professor of Neurosurgery at Northwell Health/Hofstra. Daniel added, “The TriALTIS™ Spine System offers a comprehensive implant portfolio that complements different anatomies and procedures and can help to streamline surgical workflows and enable intraoperative flexibility – all with the potential to improve clinical experiences.”

“The TriALTIS™ Spine System will be our premier pedicle screw platform designed to work seamlessly across our entire DePuy Synthes portfolio of enabling technology solutions,” said Russell Powers, Worldwide President, Spine, DePuy Synthes. Russell commented, “Johnson & Johnson MedTech is proud to deliver this exciting innovation that can help facilitate the surgical treatment of spinal degeneration and deformity to improve fixation, drive better patient outcomes, and potentially reduce the clinical and economic burden associated with the current standard of care. DePuy Synthes has been a leader in the complex spine space for over 35 years, and the launch of the TriALTIS™ Spine System will mark a critical milestone towards our vision to continue this legacy long into the future.”

According to DelveInsight’s “Spinal Surgery Devices Market” report, the global spinal surgery devices market is estimated to grow at a CAGR of 5.65% during the forecast period from 2023 to 2028. The spinal surgery devices market is observing remarkable market growth owing to various factors such as the subsequent rise in spinal disorders across the globe, increasing road accidents, and increasing demand for minimally invasive surgical procedures among others. Further, the increasing demand for technologically advanced spinal surgery devices in the market will also spur market growth in the forthcoming years. Additionally, a rise in spending on spinal surgery products along with the increasing product launches and approvals, and other factors will create a requisite for the spinal surgery devices in the market. Therefore, the market for spinal surgery devices is estimated to grow at a substantial CAGR during the forecast period from 2023 to 2028.

Biotronik Announced Positive Data for its Spinal Cord Stimulation Tech 

On October 5, 2023, Biotronik announced positive results from a clinical trial for its Neuro Prospera spinal cord stimulation (SCS) system. 

The Neuro Prospera system’s Resonance multiphase stimulating paradigm is evaluated in the BENEFIT-02 trial. It examined the stimulator’s efficacy and safety in treating patients with persistent pain. 

Resonance employs a proprietary integrated circuit architecture and uses less power than other SCS therapies currently on the market, according to Biotronik. It provides the spinal cord with a continuous, momentarily, and spatially dispersed therapeutic pulse rhythm.

Participants in Biotronik’s prospective, multicenter, randomized, single-blind feasibility trial comprised those who had persistent leg or low back discomfort. An initial numerical rating scale (NRS) for total pain intensity higher than or equal to six was provided. Patients were randomly assigned to multiphase therapy by Biotronik following a successful commercial SCS trial. 

After washout, patients had 11–12 days of testing using an experimental external pulse generator and their current leads for therapy.

There was no statistically significant difference in the mean NRS reduction or percent pain alleviation between multiphase therapies in the 65 patients who finished the research. Compared to commercial SCS, multiphase therapy was reported by 63.9% of participants to provide better pain alleviation in the at-home environment. They also mentioned an improvement in their level of physical activity and average sleep quality.

According to Biotronik, there were very few adverse effects and none that the investigators deemed to be “serious.”

The BENEFIT-02 study is a component of the Prospera SCS system research program from Biotronik. The FDA approved Prospera earlier this year. Additionally, the business reported encouraging preliminary results from its lengthy BENEFIT-03 research. Prospera is evaluated by BENEFIT-03 using remote programming, automatic daily objective device monitoring, and resonance multiphase stimulation. Significant pain reduction was observed in both in-clinic and at-home settings with less severe disability, according to interim six-month results.

“As we await additional data from our BENEFIT-03 study, we’re excited to see these initial data on the long-term effects of our SCS system,” said Biotronik Neuro President Todd Langevin. Todd added, “We developed Prospera to offer patients sustainable pain relief – and we believe its proactive care model will have a clinically meaningful impact on lowering long-term failure rates and reducing the service burden of SCS.”

According to DelveInsight’s “Spinal Cord Stimulators (SCS) Market” report, the global spinal cord stimulators (SCS) market was valued at USD 2.25 billion in 2022, growing at a CAGR of 8.70% during the forecast period from 2023 to 2028 to reach USD 3.72 billion by 2028. The demand for spinal cord stimulators (SCS) is primarily attributed to the growing number of patients with chronic pain, and neuropathic pain in the shoulder, legs, and knee. The technologically advanced devices that are non-invasive, eliminate targeted pains, and cause a reduction in patient discomfort, with no side effects are likely responsible for a boost in the global spinal cord stimulators (SCS) market growth. Moreover, favorable government regulations for commercialization and launching products in the market and the rising geriatric population are some of the factors responsible for propelling the growth of the spinal cord stimulators (SCS) market.

Contego Medical Announced Start of Enrollment in Performance III Direct Transcarotid Access Stenting Trial 

On October 6, 2023, Contego Medical Inc., a company dedicated to improving patient outcomes and procedural efficiency in the treatment of carotid and peripheral vascular disease, announced enrollment of the first patient in the PERFORMANCE III Trial.

Aiming to further assess the safety and efficacy of the Neuroguard IEP® Direct System, a carotid stent system intended for direct transcarotid access, PERFORMANCE III is a prospective, multicenter study. This research is an extension of the fully enrolled PERFORMANCE II study of the Neuroguard IEP System, which assessed the identical stent inserted with either transradial or transfemoral percutaneous access. This research is an extension of the fully enrolled PERFORMANCE II study of the Neuroguard IEP System, which assessed the identical stent inserted with either transradial or transfemoral percutaneous access.

The US Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) for the conduct of the PERFORMANCE II and PERFORMANCE III trials. 

Utilizing Contego Medical’s integrated embolic protection (IEP) technology, the Neuroguard IEP and Neuroguard IEP Direct Systems provide enhanced safety during stent placement and balloon dilation. IEP technology is a unique platform featuring a micro-filter integrated into the delivery catheter. By capturing the micro-emboli that other protection methods miss, the micro-filter provides doctors with the procedural confidence that comes with improved stroke protection when treating patients. An innovative single-access-point blood flow reversal technology made especially for direct transcarotid access is also included with the Neuroguard IEP Direct technology. 

By combining the stent, balloon, and micro-filter into one 3-in-1 catheter, the Neuroguard system reduces the need for several catheter exchanges and enhances treatment effectiveness. In addition, Neuroguard makes use of the tried-and-true FlexRingTM stent technology, which combines the advantages of open and closed cell stents with the long-term material performance of nitinol.

“At Contego, we’re driven to improve patient outcomes and will continue to collect robust clinical data to build upon the unprecedented stroke protection results already demonstrated with our IEP (integrated embolic protection) platform technology in the PALADIN and PERFORMANCE I studies,” said Dr. Ravish Sachar, CEO of Contego Medical. 

Stacy Enxing Seng, Operating Partner at Lightstone Ventures and Chairman of the Board of Contego Medical, added: “Contego is committed to advancing care for patients by providing best-in-class stent, balloon, and filter technology so all physicians in the vascular community have the best tools at their disposal, no matter how they choose to access the carotid artery.”

“We look forward to studying the Neuroguard IEP Direct System and determining its potential as a new option for patients with carotid artery stenosis,” said Dr. Sean Lyden, Chairman of the Department of Vascular Surgery at Cleveland Clinic and Co-National Principal Investigator of the PERFORMANCE III Trial.

“I have no doubt the Neuroguard IEP Direct system will elevate the standard of care for carotid artery stenosis patients,” commented Dr. Robert Mendes, a vascular surgeon at the University of North Carolina Rex Hospital, who treated the first patient in the PERFORMANCE III study. Dr. Robert mentioned, “Its safety is unmatched, and it is simple and efficient to operate. This is an across-the-board advancement in technology in every aspect of the system, from the optimized direct access kit to the blood flow reversal system to the added integrated embolic protection (IEP). It’s a 3-in-1 leap forward in catheter design.”

According to DelveInsight’s “Stents Market” report, the global Stents market is estimated to grow at a CAGR of 5.61% during the forecast period from 2023 to 2028. The stents market is witnessing positive growth owing to factors such as the increasing prevalence of chronic diseases, rise in the geriatric population, increasing demand for minimally invasive procedures, and increase in unhealthy lifestyles, all factors contributing to the growth of the stents market during the forecast period from 2023-2028.