“As the number of people with AFib grows around the world, physicians are looking for integrated and flexible tools to help deliver safe, effective and efficient cardiac ablation procedures,” said Tom De Potter, M.D., Head of Electrophysiology and Associate Director of the Heart Center, OLV Hospital, Aalst, Belgium. “Both PF and RF energy have important advantages in clinical practice. With the Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter, having the ability to easily switch between RF and PF energy provides the flexibility to customize treatment depending on the patient anatomy and clinical need, enabling electrophysiologists to perform more targeted ablation procedures which could lead to improved outcomes for patients.”
“Based on our collaboration with electrophysiologists around the world, we know that each AFib procedure is different; having both RF and PF energy through one device will allow physicians to personalize each procedure based on patient anatomy and clinical need and offer a point-by-point workflow that many of our customers prefer,” said Jasmina Brooks, President, Electrophysiology, Johnson & Johnson MedTech. “The Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter offers the benefit of both energy modes in one familiar device. We are pleased to bring forward this innovation to enable electrophysiologists to deliver safe and effective procedures for patients in Europe impacted by AFib.”
The Dual Energy THERMOCOOL SMARTTOUCHTM SF Platform is a cutting-edge solution for cardiac arrhythmia treatment, consisting of the Dual Energy THERMOCOOL SMARTTOUCHTM SF Catheter and the TRUPULSE™ Generator. This platform enables both pulsed field (PF) and radiofrequency (RF) energy delivery to the catheter, with seamless toggling between the two energy sources via the generator monitor. The catheter and generator are fully integrated with the CARTO™ 3 System, the world’s leading platform for electro-anatomical mapping, providing live 3D mapping and advanced visualization during ablation procedures. Notably, the Dual Energy THERMOCOOL SMARTTOUCHTM SF Catheter is the first of its kind to integrate both PF and RF energy with a PF and RF tag index, offering enhanced precision and flexibility in the treatment of cardiac arrhythmias.
As per DelveInsight’s “Cardiac Ablation Devices Market Report”, the global cardiac ablation devices market was valued at USD 2.25 billion in 2023, growing at a CAGR of 12.77% during the forecast period from 2024 to 2030, to reach USD 4.63 billion by 2030. The demand for cardiac ablation devices is motivated by a rise in the prevalence of cardiovascular diseases like cardiac arrhythmia, atrial fibrillation, and stroke. Additionally, minimally invasive procedures like cardiac ablation are gaining traction due to their advantages over traditional open-heart surgeries. Patients prefer these procedures because they offer shorter recovery times, reduced hospital stays, and lower risks of complications such as infection and bleeding. Furthermore, the growing awareness about cardiac arrhythmias and advancements in diagnostic technologies have led to earlier detection through screening programs. As awareness increases among patients and healthcare providers alike, there is a corresponding rise in the number of cases diagnosed and treated. This trend not only expands the market for cardiac ablation devices but also supports timely intervention and better management of cardiac conditions, improving overall patient outcomes during the forecast period from 2024 to 2030.
Medtronic Achieved CE Mark Approval For Brainsense™ Adaptive Deep Brain Stimulation and Electrode Identifier, a Groundbreaking Advance in Personalized, Sensing-Enabled Care for People with Parkinson’s Through Innovative Brain-Computer Interface Technology
On January 13, 2025, Medtronic plc, a global leader in healthcare technology, announced the receipt of CE (Conformité Européenne) Mark approval in the European Union (EU) and the United Kingdom (UK) for its BrainSense™ Adaptive Deep Brain Stimulation (aDBS) and BrainSense™ Electrode Identifier (EI). This approval signifies that the devices meet the stringent standards of the EU Medical Device Regulation (MDR), marking a significant milestone in personalized deep brain stimulation (DBS) therapy for individuals with Parkinson’s disease in Europe, including the UK.
BrainSense™ aDBS offers patients real-time, adaptive therapy by dynamically adjusting stimulation levels based on each individual’s unique brain activity, providing enhanced treatment both in clinical environments and during daily life. Additionally, the BrainSense™ Electrode Identifier optimizes DBS programming by ensuring more accurate initial contact selection, reducing the time required for optimal programming. This combination of innovations represents a major advancement in the management and treatment of Parkinson’s disease.
“BrainSense™ technology is at the center of personalizing DBS therapy, and we are advancing this capability through innovation that builds on our sensing-enabled DBS platform,” said Paolo Di Vincenzo, president of the Neuromodulation business, which is part of the Neuroscience Portfolio at Medtronic. “From improved precision for contact selection to automatically adjusting DBS therapy, these milestones mark significant advancements in our ability to customize care for people with Parkinson’s, and we’re just getting started. The mission is to impact and improve many more lives with Medtronic DBS therapy.”
The Medtronic Percept™ DBS system, featuring BrainSense™ technology, is a groundbreaking solution designed to record and analyze brain signals, enabling personalized therapies tailored to each patient’s unique neurological patterns. Medtronic has been a leader in integrating brain-computer interface (BCI) technology into deep brain stimulation (DBS) therapy, with a focus on advancing the prevention, detection, diagnosis, rehabilitation, and restoration of patients with complex neurological conditions.
“Adaptive deep brain stimulation represents an exciting evolution in how we manage Parkinson’s,” said Martijn Beudel, MD, PhD, neurologist and associate professor, Department of Neurology, Amsterdam University Medical Center. “By using real-time brain activity to automatically adjust stimulation, this technology enhances the ability to deliver patient-specific stimulation that can be adapted to an individual’s unique needs.”
The BrainSense™ Electrode Identifier (EI) takes precision and efficiency in Parkinson’s disease treatment to new heights by providing clinicians with a detailed view of each patient’s unique brain signals. This innovative technology significantly reduces the time required to identify the optimal stimulation site, pinpointing the strongest signal location in a fraction of the time compared to traditional monopolar reviews. By utilizing local field potentials (LFP) and alpha-beta activity, the BrainSense™ EI ensures more accurate and effective programming, guiding clinicians to the optimal contact location for each patient. This advanced approach enhances the personalization of deep brain stimulation (DBS) therapy, offering improved results over the standard monopolar review method and advancing the precision of Parkinson’s disease management.
As per DelveInsight’s “Deep Brain Stimulation Devices Market Report”, the global deep brain stimulation devices (DBS) market was valued at USD 1.31 billion in 2023, growing at a CAGR of 10.40% during the forecast period from 2024 to 2030 to reach USD 2.37 billion by 2030. The demand for deep brain stimulation (DBS) devices is experiencing growth due to the increasing prevalence of neurological disorders, such as Parkinson’s disease and epilepsy. The rising geriatric population, which is more susceptible to these disorders, is a major factor driving this trend. Additionally, the growing focus on research and development (R&D) and technological advancements in product innovation are contributing significantly to the positive growth of the deep brain stimulation devices market during the forecast period from 2024 to 2030.
Inquis Medical Completed Enrollment in U.S. Pivotal IDE Trial of the Aventus Thrombectomy System Designed to Treat Patients with Pulmonary Embolism
On January 13, 2025, Inquis Medical, a leading innovator in venous thromboembolic disease treatment, announced the successful completion of patient enrollment in its AVENTUS Clinical Trial, a pivotal Investigational Device Exemption (IDE) trial designed to assess the safety and efficacy of the Aventus Thrombectomy System for treating pulmonary embolism (PE).
A total of 130 patients with intermediate-risk PE were enrolled in the AVENTUS Clinical Trial, which is a multi-centered, prospective, single-arm study conducted across more than 20 renowned clinical sites in the United States. This milestone marks a significant step forward in Inquis Medical’s mission to advance treatment options for venous thromboembolic diseases. With full enrollment now complete, the company is poised to further demonstrate the potential of the Aventus Thrombectomy System to revolutionize the treatment of PE.
“This trial is a key step toward delivering a more streamlined, efficient, and precise thrombectomy solution for treating life-threatening blood clots,” said Dr. Jun Li, Co-Director of the Vascular Center and Pulmonary Embolism Response Team at University Hospitals Harrington Heart & Vascular Institute and the trial’s National Co-Principal Investigator (PI). “The AVENTUS system stands out with its unique combination of streamlined blood return, directional aspiration, and the elimination of multiple dilator or wire exchanges, offering an elegant and efficient solution for removing thrombi in PE patients.”
“The AVENTUS pivotal trial represents a new option for treating pulmonary embolism,” said the trial’s National Co-Principal Investigator, Dr. Saher Sabri, Professor of Radiology at Georgetown University School of Medicine, Chief of Interventional Radiology at MedStar Health, and Division Chief of Interventional Radiology at MedStar Georgetown University Hospital. “We are grateful to the 130 patient volunteers in this trial and to our colleagues who helped rapidly enroll participants reflecting the clinical community’s strong dedication to advancing care in this field.”
“Completing enrollment in the AVENTUS Pivotal Study marks a significant milestone, highlighting the potential of the AVENTUS system to streamline and enhance treatment while underscoring Inquis Medical’s commitment to driving innovation and elevating standards of care in venous thromboembolic disease management,” said Mojgan Saadat, Co-Founder and Co-CEO of Inquis Medical. “We sincerely thank the patients, investigators, and site clinical research staff for their efforts in bringing this trial to fruition.”
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.
Argon Medical Announced First Patient Enrollment in CLEAN-PE, a Prospective, Multicenter Study of a New Treatment for Pulmonary Embolism
On January 09, 2025, Argon Medical, a leading provider of device solutions for Interventional Radiology, Vascular Surgery, Interventional Cardiology, and Oncology procedures, announced the enrollment of the first patient in the CLEAN-PE study. This prospective, multicenter study aims to evaluate the safety and efficacy of the Cleaner™ Pro Thrombectomy System for the removal of blood clots from the lungs in patients diagnosed with pulmonary embolism (PE).
The CLEAN-PE study is expected to enroll over 100 patients across multiple hospital facilities throughout the United States. The study is being led by Dr. Aravinda Nanjundappa, MD, an Interventional Cardiologist at the Cleveland Clinic in Cleveland, Ohio, serving as the National Principal Investigator. The first patient procedure was successfully performed at Buffalo General Medical Center in Buffalo, New York, by Interventional Cardiologist Dr. David M. Zlotnick, MD. This marks a significant step in evaluating the Cleaner™ Pro Thrombectomy System’s potential for improving PE treatment outcomes.
“We are proud to enroll the first patient in the CLEAN-PE study utilizing the Cleaner™ Pro Thrombectomy system. Unique treatment options are emerging for the management of this patient population. We are excited to evaluate a new device for patients diagnosed with pulmonary embolism.” said David M. Zlotnick, Interventional Cardiologist, Buffalo General Medical Center.
“Data indicates that pulmonary embolism mortality rates have increased in the last decade. We aim to help physicians improve patient outcomes by developing new solutions that enable quicker and easier PE interventions. Enrolling the first patient into the CLEAN-PE study is a monumental step forward for the solution we designed, and we are excited to discover the difference The Cleaner Vac Thrombectomy System can make for patients with this life-threatening condition.” said George Leondis, President & CEO, Argon Medical.
The Cleaner™ Pro Thrombectomy System is a catheter-based aspiration thrombectomy device designed for the removal of blood clots. The system includes a user-controlled handpiece, a large-bore aspiration catheter, a dilator, and a single-use aspiration pump and canister. This comprehensive system allows for efficient clot removal through controlled aspiration, offering a potential solution for the treatment of pulmonary embolism (PE) and other thromboembolic conditions.
According to DelveInsight’s “Neurovascular Embolization Devices Market Report”, the global neurovascular embolization devices market was valued at USD 1.29 billion in 2023, growing at a CAGR of 3.50% during the forecast period from 2024 to 2030, to reach USD 1.59 billion by 2030. The rise in the demand for neurovascular embolization devices is predominantly attributed to the increasing prevalence of hemorrhages and the abnormalities in blood vessels present in the brain, increasing brain aneurysms, and arteriovenous malformations (AVMs) due to sedentary lifestyles. Moreover, the rise in the geriatric population, the increasing prevalence of high blood pressure, and the launch of various embolization products, among others are the factors responsible for the global neurovascular embolization devices market growth.
Sutter Health and GE HealthCare Entered Strategic Partnership to Benefit Patients, Physicians and Clinicians with Advanced, AI-Powered Imaging, Enhancing GE Healthcare’s Array of AI-enabled Devices with Advanced Expertise
On January 14, 2025, GE HealthCare and Sutter Health announced a strategic enterprise partnership, called the Care Alliance, designed to expand access to innovative imaging services and create a more seamless, coordinated experience for clinicians and patients across the Sutter Health system. This long-term collaboration aims to enhance access to essential diagnostic care throughout California, providing patients with advanced imaging technology in their local communities. The initiative will enable quicker appointment scheduling, faster diagnostic imaging results, early diagnoses, greater convenience, and more consistent, timely care. The Care Alliance represents one of GE HealthCare’s largest-ever enterprise strategic partnerships, underscoring its commitment to improving healthcare delivery and patient outcomes.
“This strategic partnership is rooted in our commitment to providing innovative, high-caliber care to our 3.5 million patients across Northern California and the Central Coast,” said Warner Thomas, president and CEO of Sutter Health. “We’re responding to what we’ve heard from our physicians and making comprehensive upgrades with the latest technology to boost our capacity and expand access points. This collaboration ensures that no matter where patients enter the Sutter Health system, they’ll receive seamless and coordinated care.”
The first key focus of the Care Alliance between GE HealthCare and Sutter Health is an accelerated technology program across the Sutter Health system. This initiative will integrate some of the most advanced AI-powered imaging technology and digital solutions available to patients, including PET/CT, SPECT/CT, MRI, CT, X-ray, nuclear medicine, and ultrasound. Additionally, GE HealthCare’s interventional, mammography, diagnostic cardiology, maternal and infant care, and anesthesia solutions will be incorporated into Sutter Health’s ambulatory care centers, addressing the increasing demand for care outside traditional hospital settings.
“We are committed to support Sutter Health in its mission and have deep respect for their openness to a collaboration that meets the heart of their needs,” said Catherine Estrampes, U.S. and Canada president & CEO at GE HealthCare. “This Care Alliance is a customized, clinician-focused approach aligned with our shared goals. It was jointly designed with expert assessment of how we provide our latest imaging technology in the right settings to serve patients most efficiently throughout their care journey, closer to home. We look forward to supporting Sutter Health physicians and clinicians in delivering enhanced patients’ outcomes.”
This agreement strengthened GE HealthCare’s portfolio of AI-enabled devices, placing it at the forefront of the FDA’s list of AI-enabled device authorizations among medical technology companies. It also reinforces the company’s precision care strategy, aimed at resolving inefficiencies in clinical care workflows and elevating patient care quality throughout the care continuum.
The strategic partnership is also a critical component of Sutter Health’s broader access strategy, which includes the opening of dozens of new care sites across Northern California in the coming years. The collaboration will further support the expansion of advanced service lines and destination centers of excellence, particularly in areas such as heart and vascular care, cancer care, and neurosciences.
According to DelveInsight’s “Diagnostic Imaging Equipment Market Report”, the global diagnostic imaging equipment market was valued at USD 24.15 billion in 2023, growing at a CAGR of 5.10% during the forecast period from 2024 to 2030, to reach USD 33.56 billion by 2030. The demand for Diagnostic Imaging Equipment is primarily attributed to the rising technological advancement, the growing burden of chronic diseases, increasing patient awareness regarding early-stage diagnosis, the growing demand for effective & efficient imaging technologies for diagnosis, and the increasing geriatric population.
Saluda Medical Announced Closing of USD 100 Million Financing, Strengthening Capabilities in Neuromodulation Product Portfolio
On January 10, 2025, Saluda Medical, Inc., a commercial-stage medical device company specializing in treatments for chronic neurological conditions, successfully closed a USD 100 million financing round. The financing was led by existing investor Redmile Group, with additional support from Wellington Management, TPG Life Sciences Innovation, Fidelity Management & Research Company, Action Potential Venture Capital, and T. Rowe Price Associates, Inc. New investor Piper Heartland Healthcare Capital also participated in the round.
The net proceeds from this financing will primarily be used to advance the commercialization of the Evoke® System, the first commercial application of Saluda Medical’s proprietary closed-loop, dose-control neuromodulation platform.
The Evoke® System is an innovative physiologic closed-loop, dose-control spinal cord stimulation (SCS) system designed to manage chronic pain, which affects an estimated 20% of the global population, including 67 million people in the United States. While spinal cord stimulation is a well-established therapy for chronic pain, the Evoke® System stands apart as the first system capable of sensing and measuring neural responses to stimulation and automatically adjusting therapy to achieve and maintain a targeted level of neural activation. This ensures that therapy remains at the patient-specific prescribed level, offering more consistent and effective outcomes 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.
