Initial cases using the Volt PFA System were performed by leading electrophysiologists, including Prof. Helmut Puererfellner at Ordensklinikum hospital in Linz, Austria; Prof. Roland Tilz at the University Heart Center in Luebeck, Germany; Prof. Gian-Battista Chierchia at the University of Brussels in Belgium; and Prof. Peter Loh at the University Medical Center Utrecht in the Netherlands.
“The launch of Abbott’s Volt PFA system marks a major milestone in the evolution of electrophysiology across Europe and signals we’re moving beyond early therapy approaches to new systems that incorporate key physician feedback and clinical insights to optimize PFA therapy,” said Prof. Puererfellner. “PFA is significantly changing our approach to treating patients, and it’s exciting to see the Volt PFA System build on the therapy’s potential and bring new benefits to clinical teams so we can improve the lives of more patients battling conditions like AFib.”
“While PFA is a relatively new therapy option, we’ve incorporated lessons learned from first-generation devices and designed the Volt system to simplify PFA procedures while making them more efficient,” said Christopher Piorkowski, M.D., chief medical officer of Abbott’s electrophysiology business. “Clinical data has also shown that the Volt catheter’s cutting-edge design helps physicians achieve pulmonary vein isolation in fewer ablation attempts and less therapy applications for improved patient outcomes.”
The Volt PFA System provides a simplified workflow with a single-catheter approach, improving clinical procedures and offering real-time contact visualization to assist physicians in accurately positioning the catheter for therapy delivery. Its proprietary balloon-in-basket design, Sensor Enabled™, allows for efficient energy transfer directly to the targeted tissue, minimizing the number of therapy applications required to stop erratic heart signals. Additionally, the system offers procedural flexibility, enabling patients to undergo minimally invasive ablation procedures with either light sedation or general anesthesia, depending on the physician’s and hospital’s preferences.
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.
Zimmer Biomet Received CE Mark Approval for RibFix Advantage® Fixation System, Expanding Thoracic Portfolio
On April 01, 2025, Zimmer Biomet Holdings, Inc., a global leader in medical technology, announced that its RibFix Advantage® Fixation System received CE Mark certification, marking the first-ever CE Mark for an intrathoracic rib fixation system. The RibFix Advantage Fixation System is designed for the thoracoscopic fixation, stabilization, and fusion of rib fractures, offering a minimally invasive alternative to traditional open reduction internal fixation. This approach reduces soft tissue disruption, potentially improving patient recovery. The system’s RibFix Advantage Bridge adapts to the rib anatomy during tightening, auto-contouring to help reduce fractures. This innovative system and its associated surgical technique represent a significant advancement in the management of rib fractures, offering enhanced procedural efficiency and patient outcomes.
“Following the success of RibFix Advantage Fixation System in the United States and other markets, we are excited to introduce it in CE Mark markets and support our customers with solutions that meet their evolving surgical needs,” said Wilfred van Zuilen, Zimmer Biomet Group President, EMEA. “We remain dedicated to advancing MedTech and delivering high-quality solutions for healthcare professionals and their patients worldwide.”
With the CE Mark certification, Zimmer Biomet will now make the RibFix Advantage Fixation System available across the European Economic Area (EEA) and in other markets that recognize the CE Mark, expanding access to this innovative solution for rib fracture management.
As per DelveInsight’s “ Trauma Fixation Devices Market Report, the global trauma fixation devices market was valued at USD 6.61 billion in 2023, growing at a CAGR of 6.41% during the forecast period from 2024 to 2030 to reach USD 10.08 billion by 2030. The trauma fixation devices market is experiencing significant growth due to the rising incidence of trauma cases, which are often the result of road traffic accidents. These accidents frequently lead to severe traumatic injuries, including fatal injuries and traumatic spinal cord injuries. These devices play a critical role in stabilizing and supporting bones and soft tissues, thereby facilitating the healing process, thus acting as major factors contributing to the overall growth of the trauma fixation devices market during the forecast period from 2024 to 2030.
Teleflex Announced Preliminary Clinical Results from IDE Study on Ringer™ Perfusion Balloon Catheter (PBC), Investigating for Management of Coronary Perforations
On March 27, 2025, Teleflex Incorporated, a leading global provider of medical technologies, announced the preliminary results of its Ringer™ PBC IDE study, which were presented at the CTO Plus Conference in New York. The study’s principal investigator, Dr. David E. Kandzari, MD, FACC, MSCAI, Chief of the Piedmont Heart Institute and Cardiovascular Services, Chief Scientific Officer, and Director of Interventional Cardiology at Piedmont Heart Institute in Atlanta, GA, shared the findings. The Ringer™ PBC is a rapid-exchange percutaneous transluminal coronary angioplasty (PTCA) catheter featuring a unique helical balloon design. When inflated, the balloon forms a hollow cylinder with a large central perfusion lumen, allowing continuous coronary blood flow during prolonged inflations, which may improve clinical outcomes in complex coronary interventions.
The Ringer™ PBC study is a limited, prospective, multi-center, single-arm Investigational Device Exemption (IDE) study conducted across four sites in the United States. The study aimed to evaluate the Ringer™ PBC for managing emergent coronary perforations that occur during percutaneous coronary intervention (PCI) procedures. A total of 30 participants were enrolled, with analysis conducted based on an intention-to-treat approach. The primary efficacy endpoint required successful delivery and inflation of the Ringer™ PBC at the perforation site, control of extravasation (defined as residual Ellis grade 0 or 1), and preservation of antegrade coronary flow (Thrombolysis in Myocardial Infarction [TIMI] grade 2 or 3).
Of the 30 participants, 22 (73.3%) met the primary efficacy endpoint. Successful Ringer™ PBC delivery was achieved in 26 participants (86.7%). Among those with successful delivery, 22 participants (84.6%) had control of extravasation with preserved perfusion. Following perforation management with the Ringer™ PBC, 12 participants were treated with a covered stent. One participant required emergency surgery due to complications from pericardiocentesis, and three participants passed away despite achieving control of extravasation from the index perforation.
“I believe these preliminary study results are important,” said Dr. Kandzari. “Treatment options for patients with coronary artery perforations during PCI cases have been limited to date, and this trial points the way to developing dedicated devices.”
“Teleflex is committed to generating the clinical evidence to help physicians make confident decisions when selecting the right products for their patients’ needs,” said Teleflex Medical Director, Christopher Buller, MD.
For its investigational use in managing coronary perforations, the Ringer™ PBC was granted the FDA’s Breakthrough Device Designation. This program is designed to expedite the development, assessment, and review process for medical devices that have the potential to offer more effective treatments or diagnostics for life-threatening or irreversibly debilitating conditions. The Breakthrough Device Designation aims to provide patients and healthcare providers with timely access to innovative devices by speeding up the premarket approval, 510(k) clearance, and DeNovo marketing authorization processes.
The Ringer™ PBC is currently indicated for balloon dilatation of coronary artery or coronary bypass graft stenoses, where the physician aims to maintain distal blood perfusion during balloon inflation to improve myocardial perfusion. However, the Ringer™ PBC used in this study is an investigational device and is not available for sale. The data collected from this study is intended to support a premarket application that has been recently submitted to the FDA.
According to DelveInsight’s “Balloon Catheters Market Report”, the global balloon catheters market was valued at USD 4.60 billion in 2023, growing at a CAGR of 8.78% during the forecast period from 2024 to 2030 to reach USD 7.62 billion by 2030. Factors such as the rising prevalence of lifestyle disorders such as hypertension and obesity which present themselves as major risk factors for the development of cardiovascular diseases as well as brain aneurysms, increasing incidence of cancers in the pelvic region affecting the urinary system in varying capacities, growing geriatric population base where age itself plays a major role in disease etiology, and technical innovation in product development such as manufacture of drug-coated balloon catheters aimed at drug delivery at the site of action among other factors are expected to drive the balloon catheters market.
Abbott Announced Late-Breaking Data from TRILUMINATE™ Pivotal Trial, Highlighting TriClip™ Benefits for Leaky Tricuspid Valve Patients
On March 31, 2025, Abbott announced late-breaking data from its TRILUMINATE™ Pivotal trial, demonstrating that the TriClip™ transcatheter edge-to-edge repair (TEER) system delivers substantial and sustained improvements in the severity of tricuspid regurgitation (TR) after two years. The results also indicate that the TriClip significantly reduces the rate of hospitalizations due to heart failure compared to traditional medical therapy while providing long-term quality-of-life benefits for patients. The TRILUMINATE™ Pivotal data, presented at the American College of Cardiology’s Annual Scientific Session (ACC.25) and simultaneously published in Circulation, underscore the effectiveness of the TriClip in reducing heart failure hospitalizations and improving both TR severity and patient quality of life over the long term.
The TRILUMINATE Pivotal trial is the first randomized, controlled clinical study to assess the safety and effectiveness of transcatheter repair with the TriClip system, comparing it to medical therapy alone in patients with severe tricuspid regurgitation (TR). The primary endpoint of the study was a composite of all-cause mortality, tricuspid valve surgery, heart failure hospitalizations, and quality-of-life improvement as measured by the KCCQ score. TR can significantly impair blood circulation, forcing the heart to work harder and causing debilitating symptoms like fatigue and shortness of breath. If left untreated, TR can lead to serious complications such as atrial fibrillation, heart failure, and even death. For patients who are not suitable candidates for surgery and continue to experience symptoms or persistent TR despite medical treatment, the TriClip offers a vital treatment option that can improve quality of life and reduce hospitalizations.
“With the TRILUMINATE Pivotal two-year results, tricuspid transcatheter edge-to-edge repair with the TriClip device for severe, symptomatic tricuspid regurgitation reduced heart failure hospitalizations compared to the control group. Improvements in tricuspid regurgitation severity and quality of life were sustained through two years,” said Saibal Kar, M.D., Los Robles Regional Medical Center in Thousand Oaks, California. “When we combine this with the consistent quality-of-life improvements people who receive the TriClip system experience, it’s clear that the benefits for patients with TR are very meaningful and TriClip offers a safe, effective and sustainable way to repair the tricuspid valve.”
“These new data reinforce the critical role TriClip plays in helping people with tricuspid regurgitation live the life they want while reducing the risk of hospitalization,” said Sandra Lesenfants, senior vice president of Abbott’s structural heart business. “Patients battling TR face serious challenges, including increased risk of heart failure, as a result of this debilitating condition. Unfortunately, many are not eligible for open-heart surgery and had limited treatment options before the approval of TriClip, a significant advancement that allows patients to reclaim their lives.”
The TRILUMINATE Pivotal study demonstrated sustained benefits for patients with severe tricuspid regurgitation (TR) after two years of treatment with the TriClip system. The results showed that TriClip continued to outperform medical therapy, meeting secondary endpoints, including a reduction in recurrent heart failure hospitalizations (HFH) and freedom from all-cause mortality, tricuspid valve surgery, and tricuspid valve intervention. After the first year, patients in the control group (receiving medical therapy) were allowed to cross over to receive TriClip, with more than half (142 out of 241 eligible patients) opting for the treatment.
Additional positive findings from the trial included a significant reduction in HFH in the treatment group compared to the control group (0.19 vs. 0.26 events/patient-year, p=0.02). Furthermore, control patients who switched to TriClip saw a decrease in HFH after receiving the device (0.5 vs. 0.35 events/patient-year). The study also showed a significant and sustained reduction in TR severity, with 84% of TriClip-treated patients achieving moderate or less TR (grade ≤ 2) compared to only 21% in the control group. Among control patients who crossed over to TriClip, 81% achieved moderate or less TR within 30 days, a significant improvement from just 3% before the switch. Lastly, TriClip-treated patients experienced a notable improvement in quality of life, with an average increase of more than 15 points in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score. Similarly, patients in the crossover group saw an average increase of 13 points in their KCCQ scores after receiving TriClip.
As per DelveInsight’s “Transcatheter Mitral Valve Repair Devices Market Report”, the global transcatheter mitral valve repair devices market was valued at USD 1,197.06 million in 2023, growing at a CAGR of 14.95% during the forecast period from 2024 to 2030 to reach USD 2,756.71 million by 2030. The transcatheter mitral valve repair devices market is expanding rapidly due to the growing prevalence of cardiovascular disorders including circulatory diseases, various heart valve diseases, increasing product developmental activities such as regulatory clearances, rising sedentary lifestyle & lifestyle-associated disorders, increasing preference for minimally invasive surgeries that are expected to escalate the overall growth of the transcatheter mitral valve repair devices market during the forecast period from 2024 to 2030.
GE HealthCare Launched Revolution™ Vibe CT System with Unlimited One-Beat Cardiac Imaging and AI Solutions, Enhancing Cardiac Imaging Capabilities
On March 28, 2025, GE HealthCare launched the Revolution™ Vibe, an advanced computed tomography (CT) system featuring unlimited one-beat cardiac imaging. This new system delivers consistent, high-quality images even in complex cases such as atrial fibrillation and heavily calcified coronaries. The Revolution Vibe integrates GE HealthCare’s AI-powered solutions, including ECG-less Cardiac, TrueFidelity DL, SnapShot Freeze 2, and Effortless Workflow, to enable faster, more accurate diagnoses, enhance the patient experience, and streamline workflows. By offering cutting-edge cardiac imaging technology, Revolution Vibe helps healthcare facilities improve operational efficiency, elevate patient care, and optimize patient outcomes.
For coronary CT angiography (CCTA) to be truly effective, the CT system must be capable of handling the most challenging cardiac exams, including irregular heart rhythms, patients with limited cooperation, and those with calcification, stents, or bypasses. These complications can create difficulties for cardiologists and radiologists, often resulting in repeat scans, inaccurate diagnoses, increased patient risk, and higher costs. To address these challenges, GE HealthCare designed the Revolution Vibe CT system. This ‘all-in-one’ solution delivers advanced cardiac CT capabilities, making CCTA more accessible to a broader range of facilities and patients. The system enhances diagnostic confidence, improves patient comfort, and boosts workflow efficiency, ensuring that healthcare providers can overcome the complexities of cardiac imaging and achieve better patient outcomes.
“Expanding access to CCTA is crucial for managing the rising prevalence of CVD, ensuring timely and accurate diagnoses for a larger patient population,” shares Jean-Luc Procaccini, President and CEO, Molecular Imaging and Computed Tomography, GE HealthCare. “Our introduction of Revolution Vibe underscores our commitment to this mission. The system is designed to encourage the broader adoption of and access to cardiac imaging, combining advanced technology with AI-powered solutions to deliver fast, accurate diagnoses and a more comfortable patient experience. It is designed to empower healthcare providers to offer the highest quality care, even in the most challenging cases.”
“Revolution Vibe has significantly enhanced our cardiac imaging capabilities, doubling our CCTA capacity while reducing scan times and improving image quality,” shares Dr. Christopher Ahlers, Radiologist and Managing Partner at Radiomed. “The advanced technology streamlines workflows, reduces reliance on invasive diagnostics, and ensures high-quality care for all patients, including those with challenging conditions. By adopting Revolution Vibe, we have improved operational efficiency, increased diagnostic confidence, and elevated patient satisfaction, positioning us at the forefront of cardiac care.”
Revolution Vibe significantly enhances cardiac imaging capabilities by enabling Unlimited One-Beat Cardiac imaging, providing clear, full-heart images at a low dose. This advanced technology improves access for patients with complex conditions, including atrial fibrillation, breath-holding difficulties, heavily calcified coronaries, in-stent restenosis, and cases without an ECG trace. With TrueFidelity DL for cardiac imaging and SnapShot Freeze 2, Revolution Vibe offers exceptional image quality with motion-free results. Additionally, the system’s ECG-less Cardiac feature simplifies patient preparation by eliminating the need for an ECG connection, making it ideal for situations requiring speed or when an ECG signal is unavailable.
The Effortless Cardiac Workflow further optimizes the system by using AI to automatically select protocols and position the patient, streamlining the process and reducing scanning time. This feature makes it easy for all users, including less experienced technologists, to perform scans. In clinical evaluations, the one-step decision tree workflow reduced exam time by 50%, saving radiologists four minutes per study. It also reduced the patient preparation process by up to five minutes per scan. Much of this time savings comes from decreased positioning time, minimized beta blocker usage, and the elimination of the ECG connection when prioritizing speed and patient access for cardiac exams.
According to DelveInsight’s “Computed Tomography (CT) Devices Market Report”, the global computed tomography devices market was valued at USD 8,400.69 million in 2024, growing at a CAGR of 6.15% during the forecast period from 2025 to 2032 to reach USD 13,460.21 million by 2032. The rising prevalence of chronic diseases, such as cancer, cardiovascular disorders, and respiratory illnesses, significantly increases the demand for diagnostic imaging, making computed tomography (CT) devices essential for early detection and monitoring. Additionally, technological advancements, including faster scanning speeds, enhanced image resolution, and lower radiation exposure, make CT devices more efficient and safer, encouraging wider adoption by healthcare providers. Furthermore, key market players are continuously developing innovative products, such as portable and AI-integrated CT systems, which improve diagnostic accuracy and expand the application of CT devices in various medical fields. Collectively, these factors are expected to boost the market for computed tomography devices during the forecast period from 2025 to 2032.
TELA Bio Announces U.S. Commercial Launch of Larger Sizes of OviTex® PRS, Advancing Soft-Tissue Reconstruction Solutions in Plastic and Reconstructive Surgery
On March 31, 2025, TELA Bio, Inc., a leading commercial-stage medical technology company specializing in advanced soft-tissue reconstruction solutions, is proud to announce the U.S. launch of larger sizes of its OviTex® PRS Reinforced Tissue Matrix. This groundbreaking product is the only tissue-based device reinforced with polymer suture embroidery, specifically engineered to meet the unique demands of plastic and reconstructive surgery. Designed to enhance surgical outcomes, OviTex PRS offers superior strength, flexibility, and support, providing a reliable solution for complex soft-tissue repairs. The expanded size offerings enable more versatile applications, further advancing TELA Bio’s commitment to improving patient care and surgical performance in the field of reconstructive medicine.
“The introduction of larger OviTex PRS sizes aligns with evolving trends in plastic and reconstructive surgery and strengthens the breadth of our offering in this space,” said Antony Koblish, Co-founder, President & CEO. “Since launching OviTex PRS in 2019, we have sold nearly 15,000 units, with year-over-year unit sales growth of 31% in 2024 alone. Plastic and reconstructive surgeons are increasingly seeking alternatives to cadaveric tissue, and this expansion reinforces our commitment to meet that demand.”
“These new sizes directly address the needs expressed by our key opinion leaders and customers,” emphasized Dr. Howard Langstein, Vice President of Medical Affairs & Surgeon Strategy. “By reducing the need for suturing multiple smaller pieces together, we aim to improve surgical efficiency and potentially reduce costs, enhancing the surgeon’s ability to reinforce larger soft-tissue challenges.”
OviTex® PRS Reinforced Tissue Matrix is designed with unique properties that support optimal soft-tissue healing. The device is permeable, allowing for effective fluid management and cellular repopulation, while facilitating the integration of cellular and microvascular growth into the recipient tissue. It features bi-directional fenestrations, which enhance conformability at the surgical site, ensuring a precise fit during the procedure. The device is made from a long-term resorbable PLGA polymer, which provides additional structure to the extracellular matrix (ECM) and maintains the device’s integrity during the critical early phases of healing.
OviTex PRS is engineered for consistent thickness, stretch, permeability, and ease of handling, promoting functional remodeling throughout the healing process. With the introduction of expanded size options, including a 25 x 30 cm oval and a 25 cm diameter circle, the OviTex PRS portfolio now offers solutions that may reduce the need for multiple smaller pieces, simplifying more complex plastic and reconstructive procedures. These larger configurations are designed to enhance surgical efficiency while providing robust, reliable support for challenging soft-tissue reconstructions.
As per DelveInsight’s “Aesthetic Implants Market Report”, the global aesthetic implants market is estimated to grow at a CAGR of 7.82% during the forecast period from 2024 to 2030. The aesthetic implants market is witnessing positive growth owing to various factors such as the increasing prevalence of breast cancer, increase in the number of cosmetic & reconstructive surgeries, rise in the product launches related to aesthetic implants, and increasing need for attractive physical appearance. Therefore, the market for aesthetic implants is estimated to grow at a significant CAGR during the forecast period from 2024 to 2030.
