Peripheral/Endo

New logo transparent with registered trademark logo logo

Beyond Thrombolysis and Thrombectomy: Designing and Conducting Successful Stroke Clinical Trials, Upcoming Webinar Hosted by Xtalks

In this free webinar, learn how scientific rationale, patient selection, treatment timing and trial execution can shape stroke clinical development. The featured speaker will discuss cytoprotective therapies, advanced imaging, endpoint selection and the potential role of adaptive and…

Merit Medical Presents Real-World Data from the AVF Cohort of the WRAP Global Registry

The 6-month target lesion primary patency (TLPP)1 and access circuit primary patency (ACPP)2 for patients in the arteriovenous fistula (AVF) cohort were 92.7% and 76.7%, respectivelyThe real-world patency results observed in the WRAP Global Registry are higher than the patency results from the WRAPSODY Arteriovenous Access Efficacy (WAVE) pivotal trial, validating the already favorable performance of the device SOUTH JORDAN, Utah, Nov. 05, 2026 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, today announced results from the AVF cohort of the WRAPSODY (WRAP) Global registry. Clinical data were presented during the New Innovations, Trials, Techniques & Devices session on Saturday, October 31, 2026, at the Controversies in Dialysis Access (CiDA)* conference held in Washington, DC. Hemodialysis is a life-sustaining therapy for patients diagnosed with advanced kidney disease. For many patients, the creation and long-term maintenance of an AVF is essential for ongoing access to blood vessels (vascular access). However, impairments in and around the fistula due to progressive narrowing (stenosis) and/or blockage (occlusion) are inevitable for some patients. These obstructions can interfere with a patient’s ability to receive hemodialysis, require repeated interventions, and may result in life-threatening consequences. The WRAPSODY™ Cell-Impermeable Endoprosthesis (CIE) was developed to restore functionality in vascular access in patients who experience stenosis/occlusion. The device’s favorable performance has been documented in the clinical trial setting.3–6 Real-world data provide insight into how a medical device performs when used in routine clinical practice, outside the controlled setting of a traditional clinical trial. The WRAP Global registry is an international, multicenter, prospective study designed to evaluate the performance of the WRAPSODY CIE in real-world clinical practice through 24 months following device placement. A total of 237 patients were enrolled in the AVF cohort across 31 sites in nine countries. The 6-month TLPP1 was 92.7%, and the 6-month ACPP2 was 76.7%. These findings align with the patency rates observed in the AVF cohort in the WAVE pivotal trial (6-month TLPP: 89.8%; 6-month ACPP: 72.8%).4 “These are the results physicians have been waiting for,” said Panagiotis M. Kitrou, MD, MSc, PhD, EBIR, FCIRSE, Co-Global Principal Investigator of the WRAP Global registry, Associate Professor of Interventional Radiology at Patras University Hospital in Patras, Greece, and a clinical consultant to Merit Medical. “Real-world insight regarding the patency of WRAPSODY provides an important benchmark for this patient population.” “The promising patency outcomes from the WRAP Global registry are likely to improve physician confidence in the clinical benefits associated with WRAPSODY and help to further optimize patient care,” said Dheeraj K. Rajan, MD, Co-Global Principal Investigator of the WRAP Global registry, Professor and Division Head in the Department of Vascular Interventional Radiology at the University of Toronto in Toronto, Canada, who also serves as a clinical advisor to Merit Medical. “These results reinforce our commitment to building a comprehensive body of clinical evidence for WRAPSODY, which includes both rigorous clinical trials and real-world practice,” said Martha G. Aronson, Merit’s President and Chief Executive Officer. “Helping physicians maintain vascular access and reduce the burden associated with repeat interventions is central to what we are working to achieve for patients receiving hemodialysis worldwide.” The WRAPSODY CIE received premarket approval from the U.S. Food and Drug Administration (FDA) in December 2024 and was approved by Health Canada in April 2025. In January 2025, Merit began commercialization of the device in the United States. The device previously received the Conformité Européenne (CE) Mark for commercial use in the European Union and is available in Brazil. In addition to the WRAP Global registry, real-world clinical outcomes of the WRAPSODY CIE are being evaluated in the WRAP North America registry, which is designed to enroll up to 250 patients in the United States and Canada. For additional information on Merit’s WRAP North America registry, please visit: https://clinicaltrials.gov/study/NCT06807099. Merit believes that the collective data from the WAVE trial, the WRAP North America registry, and the WRAP Global registry will generate evidence on the largest cohort of patients for a single indication in dialysis access to date. For more information on the WRAPSODY CIE within the United States, please visit: https://www.merit.com/product/wrapsody-cie/. For information on the device outside of the United States, please visit: https://www.merit.com/product/merit-wrapsody/. Cautionary statement regarding forward-looking statements Any forward-looking statements set forth in this release are subject to risks and uncertainties such as those described in Merit’s filings with the U. S. Securities and Exchange Commission (“SEC”). For discussion of the risks and uncertainties which may affect Merit’s business, operations and financial condition, see Part I, Item 1A, “Risk Factors” in Merit’s Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC, which Merit updated in Part II, Item 1A, “Risk Factors” in Merit’s Quarterly Reports on Form 10-Q for the quarters ended March 31, 2026, June 30, 2026 and September 30, 2026, which Merit filed with the SEC. Actual results will likely differ, and may differ materially, from anticipated results. ABOUT MERIT Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture, and distribution of proprietary medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. Merit serves customers worldwide with a domestic and international sales force and clinical support team totaling approximately 900 individuals. Merit employs approximately 7,500 people worldwide. *ABOUT CiDA Controversies in Dialysis Access (CiDA) is a leading multidisciplinary educational forum dedicated to advancing the care of patients requiring dialysis access. Established in 2003, CiDA brings together vascular surgeons, interventional radiologists, nephrologists, and other healthcare professionals to examine current challenges, emerging technologies, clinical research, and evolving approaches to dialysis access management. Through expert presentations, interactive debates, case discussions, and hands-on education, CiDA promotes collaboration and the exchange of knowledge to improve patient care. For more information, visit www.dialysiscontroversies.org. TRADEMARKS Unless noted otherwise, trademarks and registered trademarks used in this release are the property of Merit Medical Systems, Inc., its subsidiaries, or its licensors. CONTACTSPR/Media InquiriesSarah ComstockMerit Medical+1-801-432-2864 | sarah.comstock@merit.com INVESTOR INQUIRIESMike Piccinino, CFA, IRCWestwicke – ICR+1-443-213-0509 | mike.piccinino@westwicke.com TLPP (primary effectiveness endpoint) was defined as the proportion of patients who did not require an intervention due to clinically driven target lesion revascularization or target lesion thrombosis.ACPP (a secondary effectiveness endpoint) was defined as the proportion of patients without loss of vascular access anywhere within the circuit from the time of their initial treatment to the need for reintervention or abandonment of vascular access.Gilbert et al. 2021. “First Clinical Results of the Merit WRAPSODY™ Cell-Impermeable Endoprosthesis for Treatment of Access Circuit Stenosis in Haemodialysis Patients.” Cardiovasc Interv Radiol 44, no. 12 (Dec): 1903–13. doi: 10.1007/s00270-021-02953-8.Razavi et al. 2025. “Six-Month Safety and Efficacy Outcomes from the Randomized-Controlled Arm of the WRAPSODY Arteriovenous Access Efficacy (WAVE) Trial.” Kidney Int 107, no. 4 (Apr): 740–50. doi: 10.1016/j.kint.2025.01.006.Razavi et al. 2026. “One-Year Clinical Outcomes from the Randomized-Controlled Arm of the WRAPSODY Arteriovenous Access Efficacy (WAVE) Trial.” J Vasc Interv Radiol 37, no. 6 (Jun): 108593. Online ahead of print. doi: 10.1016/j.jvir.2026.108593.Razavi et al. 2026. “Safety and Effectiveness of the Wrapsody Cell-Impermeable Endoprosthesis to Treat Dysfunctional Arteriovenous Grafts: Results from the Nonrandomized Arm of the WAVE Trial.” J Vasc Interv Radiol 37, no. 6 (Jun): 108594. Online ahead of print. doi: 10.1016/j.jvir.2026.108594.

Evident Vascular Receives FDA Clearance for High-Fidelity AI Powered IVUS Imaging Platform

SAN JOSE, Calif.–(BUSINESS WIRE)–Evident Vascular, Inc., today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the Evident Vascular® Guidance System and Evident® peripheral imaging catheters. The Evident Vascular Guidance System is intended for ultrasound examination of intravascular pathology during peripheral vascular interventions. The Evident platform is designed to transform the IVUS imaging experience by bringing together high-fidelity imaging, purpose-built AI, an

JSCAI at TCT 2026: Women and Men Show Similar Short-Term Outcomes after Aspiration Thrombectomy for Pulmonary Embolism

Analysis of a trial enrolling 109 patients found broadly comparable short-term results despite signs of higher risk among women SAN DIEGO (November 3, 2026)–New research presented today at TCT 2026 found similar short-term outcomes in women and men with intermediate-risk pulmonary embolism (PE) after aspiration thrombectomy, a catheter-based procedure to […]

Inquis Medical Launches a Large Multicenter Post-Market Registry to Build on Positive AVENTUS™ Pivotal Trial Results with Real-World Evidence in Pulmonary Embolism

MENLO PARK, Calif.–(BUSINESS WIRE)– #AVENTUSThrombectomy–Inquis Medical, the leading innovator in the treatment of venous thromboembolic disease, today announced the launch of SENSE-PE, an all-comer post-market registry evaluating the safety and efficacy of the AVENTUS™ Thrombectomy System in patients treated for acute pulmonary embolism (PE). Cleared by the FDA for the treatment of PE in June 2025, AVENTUS is the only thrombectomy platform combining integrated tissue-sensing technology and directional aspiration

New XCath Documentary Goes Behind the Scenes of World-first Robotic Stroke Procedure

HOUSTON–(BUSINESS WIRE)–XCath, a medical device company advancing neuro-endovascular surgical robotics, today releases ‘Operation Robo Angel: Chapter One’, a documentary telling the inside story of the world’s first remote robotic mechanical thrombectomy on a living patient. The documentary – unveiled to coincide with World Stroke Day – is available to watch for free online. It was produced by Lucky 13 Films. Eduardo Fonseca, CEO of XCath, said: “Operation Robo Angel tells the story of what c

Microbot Medical® Secures its First Office-Based Lab (OBL) Customer for the LIBERTY® Endovascular Robotic System

ELMNT IR also became the first account on the West Coast, marking a geographic expansion which aligns with the Company’s Full Market Release strategy.  The Company believes the OBLs represent a rapidly growing healthcare segment and opportunity as many endovascular procedures are being done outside traditional hospital settings and Ambulatory Surgery Centers. HINGHAM, Mass., Oct. 27, 2026 (GLOBE NEWSWIRE) — Microbot Medical Inc. (Nasdaq: MBOT), developer and distributor of the innovative LIBERTY Endovascular Robotic System, today announced that ELMNT IR, a multisite outpatient interventional radiology practice in California, has signed an order to purchase up to a 12-month supply of LIBERTY devices. ELMNT IR became the first Office-Based Laboratory (OBL) customer in the world to utilize the LIBERTY Endovascular Robotic System, and the Company’s first customer on the West Coast. An OBL is an outpatient care setting that enables physicians to perform minimally invasive, image-guided procedures outside of the traditional hospital environment. Jonathan Steinberger, M.D., co-founder of ELMNT IR and a board-certified interventional radiologist specializing in minimally invasive, image-guided treatments for vascular disease, cancer, men’s health conditions, and complex venous disorders, has already performed multiple procedures using the LIBERTY System, including Y90 mapping, which is a planning procedure performed before Y-90 radioembolization, for the treatment of liver tumors, Prostate Artery Embolization (PAE) for the treatment of benign prostatic hyperplasia (BPH), and Genicular Artery Embolization (GAE) for symptomatic knee osteoarthritis. “Having used LIBERTY for multiple procedures, I’ve found that the combination of a compact footprint, efficient workflow, and the elimination of upfront capital costs and expenses associated with traditional equipment makes LIBERTY an optimal system for establishing an Endovascular Robotic Program in an OBL,” said Jonathan Steinberger, M.D., Co-Founder and Interventional Radiologist at ELMNT IR. “We have seen firsthand the value it can bring to physicians and patients. Based on our experience to date, LIBERTY is well positioned to become a standard for the use of robotics in endovascular intervention procedures.” “This is a significant milestone for us, and we believe it supports the value that LIBERTY brings across multiple sites of care settings, especially in OBLs, as we believe they are an important and growing segment of the market,” commented Harel Gadot, Chairman, CEO, President. “Our relationship with ELMNT IR, which has already resulted in advance orders of the LIBERTY System from ELMNT IR, continues a trend in which every customer that has utilized its initial LIBERTY inventory has subsequently reordered additional systems. We believe this reflects high satisfaction among physicians, as well as the acceptance by hospital administration, as they recognize the value of the system. Furthermore, in addition to expanding access to healthcare networks, this represents an additional revenue opportunity for the LIBERTY System as we expect the number of peripheral vascular interventions performed in OBLs to continue to increase.” LIBERTY is the only FDA cleared, single-use, remotely operated robotic system for peripheral endovascular procedures, and it is designed for precise vascular navigation while aiming to reduce radiation exposure and physical strain. About Microbot MedicalMicrobot Medical Inc. (NASDAQ: MBOT) is a commercial stage medical device company focused on transforming endovascular procedures through advanced robotic technology. Microbot’s LIBERTY® Endovascular Robotic System is the first single-use, remotely operated robotic solution designed for precision, efficiency and safety. Backed by a strong intellectual property portfolio and a commitment to innovation, Microbot is driving the future of endovascular care. Learn more at www.microbotmedical.com and connect on LinkedIn and X. Safe Harbor Statements relating to future financial and/or operating results, future adoption of products, future growth in research, technology, clinical development, commercialization and potential opportunities for Microbot Medical Inc. and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Any statements that are not historical fact (including, but not limited to statements that contain words such as “contemplates,” “continues,” “could,” “forecasts,” “intends,” “may,” “might,” “possible,” “potential,” “predicts,” “projects,” “should,” “would,” “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates” and similar expressions) should also be considered to be forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements involve risks and uncertainties, including, without limitation, market conditions, risks inherent in the commercialization of the LIBERTY® Endovascular Robotic System, and in the development of future versions of or applications for the system, market acceptance of the LIBERTY system, the length and outcome of hospital Value Analysis Committee and purchasing processes and the Company’s ability to convert sales leads into orders, uncertainty in the results of regulatory pathways and regulatory approvals, uncertainty resulting from political, social and geopolitical conditions, disruptions resulting from new and ongoing hostilities between Israel and the Palestinians, Iran and other neighboring countries, and maintenance of intellectual property rights. Additional information on risks facing Microbot Medical® can be found under the heading “Risk Factors” in Microbot Medical’s periodic reports filed with the Securities and Exchange Commission (SEC), which are available on the SEC’s web site at www.sec.gov. Microbot Medical® disclaims any intent or obligation to update these forward-looking statements, except as required by law. Contacts: IR@microbotmedical.comMedia@microbotmedical.com

Innova Vascular’s Laguna® Thrombectomy System Surpasses Primary Endpoints in Pivotal TRUST Study for Pulmonary Embolism

IRVINE, CA, UNITED STATES, October 5, 2026 /EINPresswire.com/ — Innova Vascular, Inc., a medical technology company developing minimally invasive treatments for blood clots in the vascular system, today announced positive results from its pivotal TRUST (Treating Pulmonary Embolism with Laguna Thrombectomy System) study evaluating the Laguna® Thrombectomy System for the […]