Sonex Health Announced US Clinical Study to Report Safety and Effectiveness of Office-based Carpal Tunnel Release System with Ultrasound Guidance
On March 30 2023, Sonex Health, Inc., a leader in innovative ultrasound guided therapies to treat common orthopaedic conditions and The Institute of Advanced Ultrasound Guided Procedures, founded in 2018 to support the Sonex Health mission and clinical excellence, announced enrolment of the first patient in the multicentre prospective trial of the office-based carpal tunnel release with ultrasound guidance (ROBUST) to report the safety and effectiveness of office-based carpal tunnel release with ultrasound guidance (CTR-US) in patients with symptomatic carpal tunnel syndrome (CTS).
UltraGuideCTR is a single-use, hand-held device developed by the physician co-founders of Sonex Health, Inc. Real-time ultrasound guidance enables physicians to use a minimally invasive technique while performing CTR through a small wrist incision.
The trial demonstrates the real-world clinical evidence of the safety and efficacy of CTR-US performed exclusively in an office procedure room site of service.
The ROBUST study will enroll a large cohort of subjects (n=140) suffering from symptomatic CTS, including treating patients with bilateral CTS, and follow those subjects for two years post-treatment.
Dr. Ashley Pistorio, the study’s principal investigator said, “I’m pleased to be participating in this important research to evaluate the safety and effectiveness of performing CTR-US in an office-based setting. Being able to provide my patients with this minimally invasive technique in my office, using only local anaesthesia, would be a game changer in reducing healthcare costs and improving the patient experience. The opportunity to treat patients suffering from bilateral CTS in a single procedure eliminates the need for patients to schedule two separate procedures and undergo recovery following each procedure when both wrists need to be treated.”Dr. Ashley Pistorio, the study’s principal investigator
“We are very grateful for the interest and commitment of the ROBUST investigators and their staff for the time and effort they are dedicating to advance patient care as part of this study. The experience and expertise of the ROBUST investigators are critical to evaluating the clinical benefits of using UltraGuideCTR and real-time ultrasound guidance to treat the painful and debilitating effects of carpal tunnel syndrome, as well as the health economic benefits of moving CTR procedures to a lower cost site of care that benefits both patients and providers.”Sonex CEO, Bob Paulson
As per DelveInsight’s “Carpal Tunnel Release System Market” report, the global carpal tunnel release system market was valued at USD 514.97 million in 2021, growing at a CAGR of 4.83% during the forecast period from 2022 to 2027 to reach USD 681.21 million by 2027. The carpal tunnel release system is observing a gradual market growth due to factors such as the rising prevalence of carpal tunnel syndrome globally and the increasing prevalence of other associated risk factors such as diabetes and thyroid gland imbalance. Furthermore, the growing number of product approvals and technological advancements in the product arena are some of the factors contributing to the global carpal tunnel release system market growth.
As per the Delveinsight analysis, in the type segment, the endoscopic carpal tunnel release system segment is expected to grow with the fastest CAGR during the study period of 2022-2027. This is primarily due to the reason that endoscopic carpal tunnel release systems are used in minimally invasive surgeries and due to the various advantages offered by the category. Above all, there are various developments and product launches in this sphere that are expected to contribute to the market’s growth.
Laborie Launched alpHaONE, a GERD Diagnostic Device
On April 3 2023, Laborie Medical Technologies Corp. (Laborie), launched alpHaONE system that is specifically designed to diagnose gastroesophageal reflux disease (GERD) and offers up to 96 hours of monitoring data.
alpHaONE offers a unique solution with its ergonomic and compact design, enlarged and easy-to-press buttons, and fail-safe capsule delivery system that protects the patient’s esophagus.
The extensive software program included in the alpHaONE system includes a virtual instruction program that facilitates simple navigation. User-customizable symptom buttons and automatic pH data analysis further ensure a seamless user experience.
“alpHaONE is a patient-centric system that allows for comfortable monitoring and accurate, reliable data, fulfilling the needs of both patients and healthcare providers to diagnosis GERD.”Rhett Klein, Vice President of Sales and Marketing for Laborie’s GI Business Unit
According to DelveInsight’s “Gastroesophageal Reflux Disease (GERD) Devices Market” report, the global gastroesophageal reflux disease (GERD) devices market is estimated to grow at a CAGR of 9.20% during the forecast period (2022-2027). The demand for gastroesophageal reflux disease (GERD) devices is primarily being boosted by the rising number of patients suffering from obesity owing to a sedentary lifestyle, increasing technological advancements associated with GERD devices, and the rising geriatric population susceptible to developing GERD disorder contributing to the overall market growth of the gastroesophageal reflux disease (GERD) devices during the forecast period from 2022-2027. According to Delveinsight analysis, in the type segment of the gastroesophageal reflux disease (GERD) devices market, the invasive GERD devices category is expected to amass a significant share of the market revenue during the forecast period. This can be ascribed to various factors such as the rising prevalence of obesity, the rising prevalence of the geriatric population suffering from disturbances associated with oesophageal mobility, a reduced production of saliva in the mouth, and the rising product approval and launches across the world.
Abbott Received FDA Approval for Epic™ Max Tissue Valve to Treat Aortic Valve Disease
On March 30, 2023, Abbott, a global healthcare leader, announced that the US Food and Drug Administration (FDA) approved the company’s Epic™ Max stented tissue valve to treat people with aortic regurgitation or stenosis.
Epic Max is designed to achieve excellent hemodynamics or blood flow, and its low-profile frame facilitates potential future transcatheter interventions for patients. This new valve is built on the Epic surgical valve platform, leveraging its long-term performance and durability.
Blood flow to the body is decreased when the aortic valve doesn’t close completely (or doesn’t open all the way. Aortic valve disease can cause heart failure, stroke, blood clots, or even death if left untreated. In an open-heart surgical procedure, diseased or damaged heart valves that cannot be repaired may be surgically replaced with either mechanical or bioprosthetic (tissue) valves. Epic Max are recommended for patients requiring valve replacement who aren’t suitable for taking blood-thinning medication.
“The aortic valve is one of the heart valves most commonly impacted by cardiovascular disease, frequently requiring replacement. Abbott’s Epic Max design optimizes blood flow for patients and has a low profile that makes future cardiac interventions, if necessary, easier.”Joseph E. Bavaria, M.D., cardiovascular surgery, University of Pennsylvania
“With Epic Max, we’re accomplishing two important things: First and foremost, we’re improving heart valve hemodynamics, which is the purpose of the procedure. Secondly, we’re preserving options and ability for patient lifetime disease management, an ever more critical point of consideration in device therapy selection.”Michael Dale, senior vice president of Abbott’s structural heart business
According to DelveInsight’s “Transcatheter Heart Valve Replacement Devices Market” report, the global transcatheter heart valve replacement devices market is estimated to grow at a CAGR of 13.75% during the forecast period from 2022 to 2027. The transcatheter heart valve replacement market is observing significant market growth, primarily owing to the growing number of valvular heart diseases and aortic stenosis disorders across the globe.
Further, the rising focus on minimally invasive surgeries, the increasing technological advancements in device & surgical procedures, the increasing burden of the geriatric population prone to aortic stenosis, mitral regurgitation, and other cardiovascular disorders, the increasing burden of risk factors leading to valvular diseases, presence of a large number of devices in the pipeline, increasing product launches and approvals, among others will positively affect the demand for transcatheter heart valve during the forecast period from 2022-2027.
Endotronix Announced Enrolment Completion of PROACTIVE-HF Pivotal Trial
On April 4 2023, Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), announced that its PROACTIVE-HF pivotal study has successfully completed enrollment.
The study is designed to evaluate the safety and efficacy of the Cordella™ Pulmonary Artery (PA) Sensor. The data will support the pre-market approval (PMA) application for market access in the US.
PROACTIVE-HF enrolled over 450 patients across the US, Ireland, and Belgium.
Primary endpoints for the single-arm, multicentre trial includes mortality and heart failure hospitalizations as well as device safety.
The company expects to report primary endpoint data from the trial in the first half of 2024.
“Building upon a strong foundation of evidence in favor of PA pressure-guided therapy, the PROACTIVE-HF trial is investigating a more comprehensive clinical picture for both clinicians and patients. Cordella provides daily PA pressure and vital sign data to help clarify patient’s clinical status. Additionally, we are seeing high levels of engagement and lifestyle changes as a result of patients having visibility to their own data. We look forward to sharing the study results in the coming months.”Liviu Klein, MD, Section Chief of Advanced Heart Failure, Mechanical Circulatory Support, Pulmonary Hypertension, and Heart Transplant at the University of California San Francisco and national principal investigator of the PROACTIVE-HF trial
“I would like to congratulate all our clinical partners on their tremendous effort to complete enrollment for PROACTIVE-HF. Their hard work and dedication are key to improving outcomes and expanding patient access, and we appreciate their continued commitment to this trial.“Harry Rowland, CEO and co-founder of Endotronix
According to DelveInsight’s “Congestive Heart Failure Treatment Devices Market” report, the global congestive heart failure treatment devices market was valued at USD 17.41 billion in 2021, growing at a CAGR of 8.26% during the forecast period from 2022 to 2027, to reach USD 27.96 billion by 2027. The congestive heart failure (CHF) treatment devices market is witnessing positive growth owing to the rising incidence of cardiovascular diseases (CVDs), a surge in the research and development activities in product development, increasing number of the aging population who are susceptible to these diseases. Moreover, the sedentary lifestyle and extreme benefits of these devices in heart failure cases, and the growing popularity of minimally invasive interventions have further pushed for the demand of these devices, thereby contributing to the growth of the congestive heart failure (CHF) treatment devices market during the forecast period from 2022-2027.
Cadwell Launched Arc Voyager, for Remote Wireless In-Home EEG Monitoring
On April 4 2023, Cadwell Industries, Inc., a global leader in neurodiagnostic and neuromonitoring solutions, announced Arc Voyager™, a remote monitoring solution for wireless In-Home EEG was launched in the US.
Arc Voyager is a wireless remote monitoring system featuring a durable case, an integrated HD camera with automatic infrared switching, a microphone, and a rugged tablet PC with an on-screen patient video display that enables wireless EEG data capture and real-time remote monitoring with data backfill.
Through the Arc Voyager, Cadwell’s Arc Apollo+ EEG now allows doctors and technologists to wirelessly access real-time patient data from patients undergoing ambulatory tests at home. EEG data is captured by Arc Apollo+ with automatic data backfill, allowing for thorough real-time review and a full data set for daily reporting.
Arc Apollo+ is a wearable 32 or 64-channel EEG solution that sends the patient’s EEG data to Arc Voyager via Wi-Fi. It is simple for technologists to set up patients in a hospital or clinic and send them home with clear usage instructions. Untethered wearable EEG in patients’ homes increases their mobility, comfort, and freedom. In contrast to clinical studies in Epilepsy Monitoring Units, patients with epilepsy frequently experience seizures more frequently in their home environments.
“Cadwell’s continued achievements are the direct result of our partnerships and developmental collaborations with clinical experts around the globe. We are dedicated to customer-centric clinical solutions, enhancing user experiences, and improving patient outcomes.”Cadwell CEO Patrick Jensen. Patrick Jensen
According to DelveInsight’s “Electroencephalography Devices/EEG System Market” report, the global electroencephalography devices market is estimated to grow at a CAGR of 7.5% during the forecast period from 2022 to 2027. The electroencephalography devices market is observing significant market growth owing to the increasing prevalence of neurological disorders and rising awareness about them.
Further, high incidence of Alzheimer’s, epilepsy, dementia, multiple sclerosis, Parkinson’s disease, and stroke will drive the adoption of electroencephalography (EEG) devices in the market. In addition, the rising research & developmental investments by manufacturers to provide advanced brain monitoring devices is another major factor significantly contributing to the growth of the electroencephalography systems market.
Leica Biosystems Received FDA Clearance for BOND MMR Antibody Panel
On April 3 2023, Leica Biosystems, a cancer diagnostics company and a global leader in workflow solutions, announced the US Food and Drug Administration (FDA) 510(k) clearance of the BOND MMR Antibody Panel, providing a high-performing IHC Mismatch Repair (MMR) option when screening colorectal cancer patients for the identification of probable Lynch syndrome.
The importance of checking for MMR status with all newly diagnosed CRCs as a preliminary Lynch syndrome screening method is supported by current cancer treatment recommendations. IHC is one of the suggested testing methods that is increasingly being used in clinical settings.
“Pathologists can utilize the Leica Biosystems BOND MMR Antibody Panel on the BOND-III for a clear, accurate assessment of mismatch repair protein status in only 2.5 hours,” said Dr. Robert Monroe, Chief Medical Officer at Leica Biosystems. He further added, “With this panel, clinicians can feel increased confidence in their MMR results.”
“Leica Biosystems is proud to help our customers continue the fight against cancer through the fast, accurate results of the BOND MMR Antibody Panel, which provides the clinicians an important piece of the diagnostic puzzle in aiding the detection of Lynch syndrome. Our test enables targeted treatment for patients, supporting our mission of Advancing Cancer Diagnostics, Improving Lives.”Gustavo Perez-Fernandez, President of Leica Biosystems
According to DelveInsight’s “In-Vitro Diagnostics Market” report, the global in-vitro diagnostics market was valued at USD 71.01 billion in 2021, growing at a CAGR of 4.71% during the forecast period from 2022 to 2027 to reach USD93.60 billion by 2027. The in-vitro diagnostics market is anticipated to witness prosperity owing to the rising prevalence of various infectious diseases such as COVID-19, the growing prevalence of various cancers, increasing cases of hematological diseases, and increasing product development activities with respect to in vitro diagnostics, among others.
As per Delveinsight analysis, among all the regions, Asia-Pacific is expected to account for the fastest growth in revenue generation in the global in vitro diagnostics market. Factors such as the rising prevalence of lifestyle disorders such as diabetes, the increasing prevalence of various cancers, and the growing geriatric population, along with rising hematological diseases such as anemia, are expected to aid in the growth of the Asia-Pacific in vitro diagnostics market. Furthermore, an increase in disposable income and a growing focus on improving healthcare infrastructure and access are also expected to aid in the in vitro diagnostics market growth in this region.