The Latest Cardiac and Vascular News
CAMPBELL, Calif., June 30, 2025 /PRNewswire/ — Verge Medical, a privately held medical technology company focused on advancing physician-driven solutions to address persistent gaps in vascular care, today announced the acquisition of the RoVo™ System and its patented Temporary Occlusion…
www.stentit.com Watch the video Click the White paper STENTiT Enrolls First Patient in Clinical TrialEvaluating a Novel Stent with Regenerative Properties to Support Limb Preservation EINDHOVEN, The Netherlands – June 26, 2025 – STENTiT, a pioneering medical device company, developing a novel class of stents with regenerative properties, today announced the successful implantation of its Resorbable Fibrillated Scaffold (RFS). As part of the VITAL-IT 1 study, patients with chronic limb-threatening ischemia (CLTI) below-the-knee, have successfully been treated using the RFS implant. In this clinical procedure, revascularization was achieved using an endovascular approach to restore the blood flow to the foot STENTiT’s RFS device is a bioresorbable stent built from microfibers, providing structural support to instantly open, and facilitate the reconstruction of the artery. Due to the porous design of the implant, patient’s own cells infiltrate into the mesh, triggering the formation of new vascular tissue. While the artery is being reconstructed from the inside-out, the synthetic implant gradually resorbs and ultimately disappears over time. “Our goal is to bring the next generation of stents with regenerative properties, to guide the body rebuilding functional arteries and improve long-term clinical outcomes,” said Bart Sanders, CEO of STENTiT. “We are extremely proud reaching this first clinical milestone to show the potential of our technology in providing a durable solution for advanced peripheral artery disease.” VITAL-IT 1 (NCT07006467) is a prospective, non-randomized feasibility study, designed to evaluate the STENTiT’s RFS device in up to 10 patients with below-the-knee CLTI. This single-center study is being conducted at the Medical University of Graz, Austria. All study patients will be monitored for 24 months. “This first-in-human clinical study will provide an important indication on the translational potential of this new technology in CLTI patients,” said Prof. Marianne Brodmann, MD, Head of Division of Angiology at the Medical University of Graz. “This device combines key attributes of temporary structural support with regenerative properties, which could minimize the need for reinterventions.” — ENDS — About Chronic Limb Threatening Ischemia (CLTI) – CLTI is the end stage of peripheral artery disease (PAD) characterized by constant rest pain, non-healing ulcers, or gangrene caused by critically reduced blood flow to the foot. The condition affects an estimated 3.5 million people in Europe and the United States and leads to more than 250 000 amputations per year. Despite advances in the field, long-term patency in below-the-knee vessels remains poor, leaving many patients with limited durable treatment options. About the Resorbable Fibrillated Scaffold (RFS) – The RFS is a fully bioresorbable microfiber stent, designed to restore blood flow to the foot in patients with chronic limb-threatening ischemia below-the-knee. The porous structure of the stent facilitates the infiltration of patients own blood-cells, to trigger a natural healing response facilitating the growth of new functional vascular tissue. While the artery is being rebuild from the inside-out, the implant gradually dissolves, leaving no foreign material behind. The RFS is currently undergoing clinical testing in the VITAL-IT 1 first-in-human study. About STENTiT – STENTiT is a pioneering medical device company located at the High Tech Campus in Eindhoven, The Netherlands. Founded in 2017 as a spin-off from the Eindhoven University of Technology, STENTIT is developing a new class of stents with regenerative properties to set the new standard in cardiovascular treatment. The company is supported by the European Innovation Council’s EIC Accelerator program and has been selected for the 2025 MedTech Innovator cohort. For more info please visit www.stentit.com, or find us on Linkedin Technology Animation: Watch the video NOTE TO EDITORS FOR CONTACT STENTiT | Eindhoven, The Netherlands Bart Sanders, CEO T: +31 40 851 64 31 E: info@stentit.com FOR MEDIA LifeSpring Life Sciences Communication | Amsterdam, The Netherlands Leon Melens T: +31 6 538 16 427 E: lmelens@lifespring.nl DISCLAIMER: The Resorbable Fibrillated Scaffold is an investigational device, not yet approved for sale in any jurisdiction.
— Polymer-based coil minimizes artifacts in imaging — BOULDER, Colo., June 25, 2025 /PRNewswire/ — Embolization, Inc., has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Nitinol Enhanced Device (NED). The NED is a vascular embolization device…
MIAMI, June 24, 2025 (GLOBE NEWSWIRE) — InspireMD, Inc. (the “Company”) (Nasdaq: NSPR), developer of the CGuard Prime Carotid Stent System for the prevention of stroke, today announced that the U.S. Food and Drug Administration (FDA) has granted premarket application (PMA) approval of the CGuard Prime Carotid Stent System in the United States.
Pivotal trial evaluates safety and efficacy of the Hēlo™ PE Thrombectomy System for the removal of blood clots from the lungs MENLO PARK, Calif., June 23, 2025 /PRNewswire/ — E2 (Endovascular Engineering, Inc.), a medical device company advancing endovascular therapies, today announced…
Pioneering device combines precision clot removal with autologous blood reinfusion to address unmet needs in PE treatmentMENLO PARK, Calif., June 16, 2025 (GLOBE NEWSWIRE) — Inquis Medical, the leading innovator in the treatment of venous thromboembolic disease, today announced that its AVENTUS Thrombectomy System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for an expanded indication to treat pulmonary embolism (PE). The AVENTUS System is a next-generation mechanical thrombectomy platform developed in close collaboration with physicians to address critical limitations of current technologies. “The FDA’s clearance of the AVENTUS System marks a major milestone for the company,” said Vahid Saadat, Co-CEO of Inquis Medical. “It validates the tireless efforts of our team and the deep partnerships we’ve built with our physicians, all focused on solving long-standing challenges in clot removal. AVENTUS is uniquely designed to meet the needs of physicians treating this life-threatening condition quickly, effectively, and safely.” The AVENTUS Thrombectomy System, which incorporates proprietary tissue-sensing technology to help operators distinguish the type of tissue in contact with the catheter tip in real time and guide precise clot removal, was previously cleared by the FDA for use in the peripheral vasculature. Additionally, the AVENTUS Clot Management System received FDA clearance for use with the AVENTUS Thrombectomy System to enable autologous blood transfusion, allowing reinfusion of filtered aspirated blood and supporting efficient, blood-conserving clot removal. This most recent clearance extends the platform’s indication to include the treatment of pulmonary embolism. “Treating PE requires both speed and precision,” said Mojgan Saadat, Co-CEO of Inquis Medical. “The AVENTUS platform is the only thrombectomy solution with integrated tissue-sensing technology that enables precision removal of large clot burdens while streamlining blood return and reducing procedural complexity, all in a single, integrated approach. Receiving this clearance in record time speaks to the strength of our clinical data, the quality of our regulatory submission, and the incredible work of the Inquis team. We’re thrilled to launch this technology and deliver a state-of-the-art solution to physicians on the front lines of saving lives.” This regulatory milestone follows the successful completion of the AVENTUS Pivotal Trial, the first U.S. Investigational Device Exemption (IDE) study to evaluate aspiration thrombectomy with filtered blood reinfusion in intermediate-risk PE patients. The trial demonstrated excellent safety and performance across a broad range of clinical settings, with no device-related major adverse events and rapid improvement in right heart strain. The results were presented as a late-breaking clinical trial at the 2025 Society of Cardiovascular Angiography and Interventions (SCAI) Scientific Sessions and were simultaneously published in the society’s peer-reviewed journal, JSCAI. About Inquis MedicalInquis Medical is a medical device company focused on peripheral vascular innovations. The company is developing next-generation thrombectomy technology that provides physicians with improved control and precision, enhances procedural efficiency, and minimizes blood loss. Founded in 2020, Inquis Medical is led by a seasoned executive team with decades of experience in developing, launching, and supporting novel medical devices that address unmet clinical needs and deliver lasting impact. For more information, visit our website or follow us on LinkedIn. Media Contact: John Weaverinfo@inquismedical.com888-526-7738
Benefits of Humacyte’s Acellular Tissue Engineered Vessel Over Autologous Arteriovenous Fistula (AVF) in High-Risk Patients with End-Stage Kidney Disease Observed in Data Presented in Plenary Session Benefits of Humacyte’s Acellular Tissue Engineered Vessel Over Autologous Arteriovenous Fistula (AVF) in High-Risk Patients with End-Stage Kidney Disease Observed in Data Presented in Plenary Session
NEW ORLEANS, LA, JUNE 6, 2025 – Findings from a phase three, randomized controlled clinical trial demonstrate the superiority of Humacyte’s Acellular Tissue Engineered Vessel (ATEV) over autologous arteriovenous fistula (AVF) in high-risk patients with end-stage kidney disease (ESKD). These data highlight the potential of ATEV to address unmet needs […]
ALAMEDA, Calif., June 5, 2025 /PRNewswire/ — Penumbra, Inc. (NYSE: PEN) announced the U.S. Food and Drug Administration (FDA) clearance and launch of the Ruby® XL System, the longest, largest and softest coil on the marketi. The Ruby XL System is designed to help physicians achieve more…
PITTSBURGH, June 4, 2025 /PRNewswire/ – MolecuLight Corp., a global pioneer in point-of-care fluorescence imaging for rapid detection of infection causing bacteria in wounds, is pleased to announce its participation in the Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM),…
