Kirk Huntsman, Chairman and CEO of Vivos, stated, “This clearance is the latest in a series of regulatory wins for Vivos, not just in the United States, but globally. It represents the culmination of a growing body of research and regulatory approvals confirming and validating the extraordinary potential and efficacy of our proprietary Vivos technology. In addition, this landmark clearance opens up an exciting and vast new market and enables us to directly address the needs of millions of children who currently suffer from sleep-related breathing disorders such as OSA.”
Mr. Huntsman continued, “Our recently announced alliance-based marketing and distribution model has the potential to widen the funnel of potential OSA patients we see. In our new strategic business model where we work closely with medical and dental providers, we already see significant opportunities opening up to treat multiple family members of all ages. When Vivos teams up with medical professionals who treat OSA, and when parents are fully informed as to the health risks of untreated OSA on their children, we believe they will overwhelmingly choose Vivos technology over other treatment options.”
“As we continue to expand beyond dentists and move more directly and vertically into affiliations and collaborations with medical specialists, functional medicine doctors, and other sleep-related healthcare practitioners, we expect this to positively impact our new case starts, revenue growth and gross profit,” Mr. Huntsman concluded.
Vivos Therapeutics viewed this groundbreaking regulatory clearance as a substantial opportunity to capture significant market share in a sector that urgently requires innovative and effective alternatives. The company consistently demonstrated high case acceptance across diverse patient demographics as it implements its recently announced marketing and distribution strategy, which is bolstered by partnerships with medical sleep care professionals. Vivos is poised to leverage this FDA clearance by swiftly integrating pediatric care into its new provider-based marketing model, enabling rapid revenue growth with minimal investment.
As per DelveInsight’s “Sleep Apnea Devices Market Report”, the global sleep apnea devices market was valued at USD 7.53 billion in 2023, growing at a CAGR of 6.26% during the forecast period from 2024 to 2030 to reach USD 10.82 billion by 2030. The demand for sleep apnea devices is primarily being boosted due to the increasing cases of sleep apnea, and the rising population associated with obesity. Further, the rising adoption of advanced and innovative technologies, the rising awareness about sleep apnea devices, the increasing geriatric population, and the increasing product launches and approval among others, thereby contribute to the overall growth of the sleep apnea devices market during the forecast period from 2024 to 2030.
Nevro Announces the Launch of HFX AdaptivAITM, the AI-Driven Technology in Spinal Cord Stimulation
On September 24, 2024, Nevro Corp., a leading global medical device company focused on delivering transformative solutions for chronic pain management, announced the U.S. Food and Drug Administration (FDA) approval and limited market release of the HFX iQ™ system, featuring HFX AdaptivAI™. This advanced, responsive pain management platform enhances the HFX iQ spinal cord stimulation (SCS) system.
HFX AdaptivAI is unique in its integration of artificial intelligence, offering patients suffering from chronic pain an unparalleled level of personalized and responsive pain relief. This innovation builds on a robust foundation of landmark clinical research and extensive big data, positioning Nevro at the forefront of pain management technology.
“Nevro is further establishing its position as the leading developer of data-driven solutions for pain management through the launch of HFX iQ with HFX AdaptivAI,” said Kevin Thornal, Nevro’s CEO and president. “HFX AdaptivAI delivers personalized pain relief, utilizing AI and leveraging millions of data points and ten years of innovation and patient care. We believe this new solution is a major milestone, and it demonstrates our dedication to freeing patients from the burden of chronic pain through evidence-based therapies that transform patients’ lives. Importantly, HFX AdaptivAI puts patients in control of their pain relief while, at the same time, providing physicians the ability to monitor their patient’s pain journey – closing the loop that matters.”
“HFX AdaptivAI is a significant leap forward in pain management,” said Dr. Usman Latif, MD, MBA, a Harvard-trained interventional pain specialist at The University of Kansas Health System. “Drawing from landmark evidence and big data, this technology has the potential to offer patients a faster and more sustainable approach to pain relief. HFX AdaptivAI is on the right path to make a lasting impact on how we manage chronic pain and improve patient outcomes.”
“Chronic pain is a dynamic, biopsychosocial human condition unique to each individual,” said Dr. David Caraway, MD, PhD, Nevro’s chief medical officer. “To effectively treat suffering – as perceived by each patient – therapies must be personalized based on the changing experience of pain. Only HFX AdaptivAI seeks to engage with the patient and personalize the SCS therapy in real time using evidence based on algorithms and multi-dimensional metrics of pain relief, function and satisfaction.”
HFX AdaptivAI is engineered to enhance pain relief over time by continuously optimizing therapy, even after achieving a reduction of more than 50% in pain levels. This proprietary technology allows for the creation of customized therapy programs in real-time, driven by direct patient feedback. Additionally, the advanced Smart Power feature enables patients to recharge their device as infrequently as six times a year, maximizing convenience. HFX AdaptivAI also collects real-time quality of life (QoL) metrics and device data, which facilitates more effective interactions between patients and clinicians. This immediate feedback allows patients to report pain relief in significantly less time compared to traditional programming methods, making HFX AdaptivAI a truly innovative solution in chronic pain management.
As per DelveInsight’s “Spinal Cord Stimulators Market Report,” the global spinal cord stimulators market size was valued at USD 2.25 billion in 2023, growing at a CAGR of 8.70% during the forecast period from 2024 to 2030 to reach USD 3.72 billion by 2030. The demand for spinal cord stimulators 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 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 market.
Jupiter Endovascular Successfully Treated the First Patients in a Clinical Study of the Vertex Pulmonary Embolectomy System, Showcasing Precision and Control in Catheter-based Interventions
On September 19, 2024, Jupiter Endovascular, Inc., a pioneering medical technology company, successfully treated its first two patients in the SPIRARE I study (NCT06571760). This multicenter trial evaluated the Vertex Pulmonary Embolectomy System, utilizing the groundbreaking Endoportal Control™ platform technology. Designed specifically for treating Acute Pulmonary Embolism (PE), the Vertex system delivers an unparalleled level of control and precision in endovascular procedures. The initial cases were conducted at St. John Paul II Hospital in Krakow, Poland, a leading cardiothoracic specialist center affiliated with Jagiellonian University.
SPIRARE I is a prospective, single-arm, multicenter study designed to evaluate the Vertex Pulmonary Embolectomy System in patients with acute, intermediate-risk pulmonary embolism (PE). In addition to St. John Paul II Hospital, the Medical University of Vienna will serve as a second study site, with Professor Irene Lang as the principal investigator.
The trial aimed to assess the procedural and clinical benefits of PE treatment utilizing Endoportal Control™ with the Vertex system. Key endpoints include evaluating safety, right heart function, and clinical improvements from the time of the procedure through 30 days post-procedure. This comprehensive analysis will provide valuable insights into the effectiveness of this innovative approach, further enhancing treatment strategies for patients with PE.
“In these first cases, the Vertex system was successful in safely navigating through the right heart and into the pulmonary vasculature, facilitating an efficient and effective pulmonary embolectomy with no safety issues,” said Prof. Kopec, Head of the Team for the Diagnosis and Treatment of Pulmonary Circulatory Diseases at St. John Paul II Hospital. “The patients’ clinical condition and hemodynamics improved on the table during the procedure, and post-operative imaging showed noticeable improvements in right heart function.”
“Controlling interventional devices within the pulmonary arterial tree when treating patients with intermediate-risk and high-risk PE can be challenging with today’s commercially available technology,” said Dr. Stepniewski, the Pulmonary Embolism Response Team (PERT) Coordinator at St. John Paul II Hospital. “The endoportal technology enabled the large-bore Vertex system to remain stable in tachypneic patients, allowing us to quickly access and revascularize multiple areas of the pulmonary vasculature in a controlled manner when facing a high degree of cardiorespiratory movement.”
“I was pleasantly surprised that the endoportal technology provided a level of control similar to what I experience in an open surgical embolectomy, with the added ability to directly access a much wider range of vessels,” said Prof. Bartus, Professor of Medicine at the Jagiellonian University, St. John Paul II Hospital. “My team and I are very excited about studying a new technology with the potential to give us greater stability and control when treating pulmonary embolism, which may have a positive impact on patient outcomes. As a principal investigator of this study, I want to thank the Jupiter Endovascular team, Professors Boguslaw Kapelak, Jacek Legutko, and Piotr Podolec from our hospital, and director of the hospital Doctor Grzegorz Fitas, for their help and support in this first-in-human clinical trial.”
“We are delighted with the performance of our technology in these first two cases, demonstrating safe access and the ability to bring a high degree of precision and control to the successful treatment of these patients with intermediate-risk pulmonary embolism,” said Carl J. St. Bernard, Jupiter Endovascular CEO. “As the first step in our SPIRARE clinical program, we look forward to validating these positive results more broadly in this study and in the upcoming SPIRARE II pivotal trial, as well as to expanding the potential benefits of our Endoportal Control™ platform technology to additional clinical areas where we intend to improve the lives and well-being of many patients.”
The Endoportal Control™ platform technology, integrated into the Vertex system, enhances stability for various catheter interventions. This innovation empowers interventionalists to access challenging anatomical sites that are typically difficult or unsafe to reach using conventional endovascular methods. The endoportal device is introduced in a flexible, relaxed state over a guidewire to the target vascular location. Once positioned, it is pressurized with saline to secure it for therapeutic delivery. After treatment, the device can be relaxed for navigation to additional target sites or for safe removal. This approach not only improves procedural efficiency but also expands the range of treatable conditions, ultimately driving better patient outcomes and enhancing clinical capabilities.
According to DelveInsight’s “Transcatheter Embolization and Occlusion Devices Market Report”, the global transcatheter embolization and occlusion devices market was valued at USD 3.71 billion in 2023, growing at a CAGR of 9.14% during the forecast period from 2024 to 2030, to reach USD 6.25 billion by 2030. The transcatheter embolization and occlusion devices market is growing significantly due to the increasing cases of chronic disorders such as cardiovascular diseases including heart attack, atrial fibrillation, and coronary artery disease; respiratory disorders like asthma, chronic obstructive pulmonary disease (COPD), rising product developmental activities by key players, among others are expected to drive the market for transcatheter embolization and occlusion devices during the forecast period from 2024 to 2030.
Toro Neurovascular Treated the First Patient in its Clinical Trial for the SuperBore Aspiration Catheter, Marking a Key Milestone in Advancing Stroke Treatment
On September 24, 2024, Toro Neurovascular, an innovative leader in medical devices, announced the successful treatment of its first patient using the Toro 88 SuperBore Aspiration Catheter in a first-in-man clinical study. This landmark procedure was performed by renowned neurosurgeon Dr. Nobuyuki Sakai and his team at Shimizu Hospital in Japan. This achievement represents a significant milestone in Toro’s mission to revolutionize stroke treatment with advanced technology, paving the way for improved patient outcomes and enhanced procedural efficacy.
Dr. Sakai, President of Seijinkai Shimizu Hospital, commented, “Toro 88’s performance was exceptional, particularly in accessing the intricate anatomy of the cerebral vasculature. Its ability to efficiently remove large clot burden and navigate challenging conditions is impressive. I am pleased to be part of this study, which has the potential to significantly enhance stroke treatment and improve patient outcomes.”
Toro’s cutting-edge catheter technology is set to redefine standards in navigating complex neurovascular anatomy. The Toro 88 catheter, equipped with MicroFlex™ Technology and a reinforced micro-wire design, is meticulously engineered for superior control and navigation through challenging conditions. Its advanced support profile ensures exceptional maneuverability and precision, facilitating efficient access to the M1 segment of the middle cerebral artery (MCA). With a vessel-matched 0.088-inch lumen, the Toro 88 aims to enable complete clot ingestion, offering the potential to significantly enhance patient outcomes in stroke treatment.
“Our goal is to improve patient outcomes through innovation, and we are excited to showcase how our technology may streamline clot access and removal,” said Hyung Posalit, CEO of Toro Neurovascular. “We are committed to developing high-performance devices that make a meaningful difference in stroke patient outcomes. This milestone is a testament to our ongoing efforts to create real-world benefits for patients.”
Toro is dedicated to transforming thrombectomy procedures, and the inaugural use of the Toro 88 SuperBore Catheter in Japan represents a pivotal milestone in this journey. The company envisions that its devices will provide physicians with an enhanced first-line stroke treatment, potentially yielding faster and more effective outcomes. With the capability to significantly elevate the standard of stroke care, Toro catheters could also expand access to stroke therapy in developing regions, contingent on regulatory approvals. This commitment underscores Toro’s mission to improve patient care and outcomes in the fight against stroke.
According to DelveInsight’s “Neurovascular Thrombectomy Devices Market Report”, the global neurovascular thrombectomy devices/neurothrombectomy devices market was valued at USD 722.78 million in 2023, growing at a CAGR of 6.15% during the forecast period from 2024 to 2030 to reach USD 1033.33 million by 2030. The rise in demand for neurovascular thrombectomy devices/neurothrombectomy devices is predominantly imputed to the rising prevalence of neurovascular disorders across the globe which require neurovascular thrombectomy devices/neurothrombectomy devices for their treatment such as ischemic stroke and hemorrhagic stroke, the growing burden of old age population. In addition, shifting key player’s focus toward the development of technologically advanced products and initiatives to increase awareness regarding neurovascular diseases and their prevention are some of the factors among others that are likely to upsurge the market for neurovascular thrombectomy devices/neurothrombectomy devices during the forecast period.
GE HealthCare Introduced Elevated Venue Point of Care Ultrasound Solutions and New Tablet-Based Venue Sprint
On September 19, 2024, GE HealthCare, a leader in medical technology, announced the launch of its enhanced Venue ultrasound systems, introducing the innovative Venue Sprint—an ultra-portable ultrasound device that sets a new standard for point-of-care ultrasound (POCUS). The Venue Sprint integrates the powerful Venue software with AI-enabled tools, delivering uncompromised image quality and wireless probe capability compatible with Vscan Air handheld ultrasound systems. Additionally, other systems in the Venue family will now support wireless probe connectivity, advanced clinical tools, and the latest ViewPoint™ 6 updates, further enhancing efficiency and optimizing workflow.
As POCUS continues to gain traction among clinicians, its portability and ability to provide detailed images enable real-time insights at the point of care. This technology is linked to faster diagnoses and treatment decisions, improved patient outcomes, enhanced treatment accuracy, and reduced healthcare costs. Moreover, POCUS represents a promising solution to help reduce health inequities and expand access across diverse care settings.
“The Venue Sprint—and new enhancements to the Venue family—are designed to empower clinicians to deliver care wherever it is needed with the simplicity, flexibility, and support they require to make confident clinical decisions,” said Karley Yoder, General Manager, Point of Care Ultrasound and Chief Digital Officer, Ultrasound at GE Healthcare. “We are excited to expand and enhance our point of care portfolio with unique solutions that build on our strengths in digital and handheld ultrasound to help clinicians navigate the evolving healthcare landscape.”
“Venue Sprint brings exceptional value to the emergency department, maintaining the proven quality of other Venue ultrasound systems while improving the user experience with wireless transducers,” said Andrés Carlos von Wernitz Teleki, MD, emergency medicine physician, Hospital Universitario de La Princesa, Madrid, Spain. “This versatile ultrasound system can be used for high-quality assessments in critical, time-sensitive scenarios where quick access to information is decisive for patient outcomes.”
The Venue Sprint is a portable ultrasound system designed in a tablet format, featuring wireless Vscan Air dual-probes that enable clinicians to deliver care across various environments, including critical care, emergency medicine, and medical transport. This innovative system provides excellent image quality and shares a common platform with other Venue systems, streamlining the learning process and ensuring a consistent user experience. Equipped with AI-enabled resources and documentation tools, Venue Sprint simplifies manual processes and enhances consistency, a benefit shared across the entire Venue family of products. Additionally, other Venue ultrasound systems will have the option to integrate wireless Vscan Air dual-probes, further expanding their capabilities.
According to DelveInsight’s “Ultrasound Devices Market Report”, the global ultrasound devices market size is estimated at USD 6.76 billion in 2023 and is expected to reach USD 6.82 billion by 2030, growing at a CAGR of 10.05% during the forecast period from 2024 to 2030. The ultrasound devices market is witnessing positive growth owing to the rising incidence of severe chronic diseases such as cardiovascular, urology, and others, further rapid technological developmental activities, growing awareness for early disease detection, and increasing geriatric population across the globe who are more susceptible to developing chronic disorders, and rising adoption owing to no radiation exposure, thereby contributing to the growth of the ultrasound devices market during the forecast period.
Linear Health Announced that the FDA Granted Expanded Indications for its Orchid Safety Release Valve, Enhancing Patient Safety
On September 24, 2024, Linear Health Sciences, a pioneering medical device company known for its proprietary breakaway safety valve platform, received an expanded indication from the U.S. Food & Drug Administration (FDA) for its Orchid Safety Release Valve (SRV™). This sterile, single-use connector facilitates needle-free access, enabling quick, simple, and hygienic returns to treatment while enhancing the experience for both patients and clinicians. The Orchid SRV™ is now indicated for use in patients aged two weeks and older during intermittent or continuous infusion, and it is approved for use during the transfusion of blood and blood products. This expanded indication underscores Linear Health’s commitment to improving patient safety and streamlining clinical workflows.
“The Orchid SRV has been shown to significantly reduce IV dislodgement and its associated costs and complications,” said Rob Headley, vice president of sales and business development at Linear Health Sciences. “This, our third expanded indication, reflects a significant shift in the potential for a new gold standard of care, creates a valuable functional moat competitively and expands our total addressable market exponentially.”
“It’s crucial to protect IV access during blood administration for critical patients, to ensure a stable and uninterrupted flow of blood products, which can be life-saving,” said Jon Bell, MSN, RN, VA-BC, CEN, emergency department & cardiopulmonary services director at Mount Desert Island Hospital in Bar Harbor, Maine. “Orchid SRV can be used to safeguard the patient’s line even during blood administration, and is an innovative and valuable lifeguard for those who are already in a fragile condition.”
“Approval for blood transfusion is a huge step forward,” said Dennis Woo, RN, interventional vascular access specialist. “Reducing instances of catheter hub exchange for procedures as common as transfusion will greatly minimize exposure in the hematology/oncology population, while continuing to reduce risk of IV loss.”
The Orchid Safety Release Valve (SRV) demonstrated a significant reduction in IV dislodgement, along with its associated costs and complications. This innovative IV dislodgement-prevention device is now approved for use with blood and blood product transfusions. Earlier this year, Linear Health Sciences secured a contract with the U.S. Department of Veterans Affairs (VA) for the Orchid device, in collaboration with GS2.
Moreover, the Orchid SRV was evaluated at over a dozen clinical sites, achieving clinical acceptance rates exceeding 92 percent. A growing number of hospitals and healthcare systems are actively assessing the device, recognizing the enhanced protection that the Orchid SRV offers in improving patient safety and reducing complications in intravenous therapy.
According to DelveInsight’s “Drug Infusion Systems Market Report”, the global drug infusion systems market was valued at USD 11.73 billion in 2023, growing at a CAGR of 8.85% during the forecast period from 2024 to 2030 to reach USD 19.45 billion by 2030. The demand for drug infusion systems is primarily being boosted by the rising prevalence of chronic diseases such as cancer, diabetes, and others coupled with the increasing geriatric population and technological advancements in product development among others. Therefore, the market for drug infusion systems is estimated to grow at a substantial CAGR during the forecast period from 2024 to 2030.
