MIAMI, Jan. 21, 2025 /PRNewswire/ — The Amavita Foundation, a leading organization dedicated to advancing cardiovascular health and supporting patients facing chronic limb-threatening ischemia (CLTI), is pleased to announce the appointment of Patty Vila to its Board of Directors. A…
Peripheral/Endo
SIRPAD – WORLD’S LARGEST RCT INVESTIGATING MAGICTOUCH PTA SIROLIMUS COATED BALLOON COMPLETES PATIENT ENROLMENT
TAMPA, Fla., Jan. 20, 2025 /PRNewswire/ — Concept Medical Inc. (CMI), a global leader in innovative drug-delivery technology across vascular interventions, proudly announces the successful completion of patient enrolment in the SirPAD Trial, with over 1,250 patients now enrolled. The…
Venova Medical Announces First Subjects Enrolled in VENOS-2 IDE Study of the Velocity Percutaneous AVF System
The VENOS-2 prospective, multicenter study is being performed under an Investigational Device Exemption (IDE) granted by the FDA and will evaluate the feasibility of the company’s Velocity pAVF System which is designed to enable a minimally invasive approach for the […]
Inquis Medical Completes Enrollment in U.S. Pivotal IDE Trial of the Aventus Thrombectomy System Designed to Treat Patients with Pulmonary Embolism
MENLO PARK, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) — Inquis Medical, a leading innovator in venous thromboembolic disease treatment, today announced completion of patient enrollment in its AVENTUS Clinical Trial, a pivotal Investigational Device Exemption (IDE) trial evaluating the safety and efficacy of the company’s Aventus Thrombectomy System for the treatment of pulmonary embolism (PE). A total of 130 patients with intermediate-risk PE were enrolled in the AVENTUS Clinical Trial, a multicenter, prospective, single-arm trial conducted at more than 20 prominent clinical sites across the United States. This achievement represents a significant milestone in Inquis Medical’s mission to deliver groundbreaking therapies for venous thromboembolic diseases. With full enrollment completed, the company is one step closer to demonstrating the potential of the Aventus Thrombectomy System to revolutionize PE treatment. “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.” About Venous Thromboembolism (VTE)In the United States, up to 900,000 individuals are affected by venous thromboembolism (VTE) annually, with over 50% of deep vein thrombosis cases progressing to pulmonary embolism (PE)—the third leading cause of cardiovascular death. Current lytic-free aspiration thrombectomy procedures often face limitations, including significant blood loss and procedural inefficiencies. Inquis Medical’s innovations aim to overcome these challenges and redefine the standard of care in the field. About Inquis MedicalInquis Medical is a clinical-stage 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 Weaver Sr. Director of Marketing, Inquis Medical info@inquismedical.com 888-526-7738
R3 Vascular Secures WCG IRB Approval and CMS Category B Medicare Coverage for the ELITE-BTK Pivotal Trial of its MAGNITUDE® Drug Eluting Next Generation Bioresorbable Scaffold for Below-the-Knee Peripheral Arterial Disease
MOUNTAIN VIEW, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) — R3 Vascular Inc., a medical device company dedicated to developing and providing novel, best-in-class bioresorbable scaffolds for treating peripheral arterial disease (PAD), is pleased to announce that it received WCG Institutional Review Board (IRB) approval for the ELITE-BTK Pivotal Trial of its MAGNITUDE Drug Eluting Next Generation Bioresorbable Scaffold for Below-the-Knee Peripheral Arterial Disease (PAD). This approval allows the trial to take place at institutions that utilize WCG IRB as their central IRB in the United States. Additionally, the company announced that the Centers for Medicare & Medicaid Services (CMS) has granted Category B approval for the investigational device exemption (IDE) study, ensuring Medicare coverage for the device, related and routine items, and services for the ELITE-BTK trial.
Argon Medical Announces First Patient Enrollment in CLEAN-PE, a Prospective, Multicenter Study of a New Treatment for Pulmonary Embolism
PLANO, Texas, Jan. 9, 2025 /PRNewswire/ — Argon Medical Devices, a leading provider of device solutions for Interventional Radiology, Vascular Surgery, Interventional Cardiology, and Oncology procedures, announced the first patient enrollment in the CLEAN-PE study. The prospective,…
Simpson Interventions Announces both IDE approval from FDA for Acolyte™ Catheter System and 510(k) clearance for its Shadow Catheter™, adds Board Member
CAMPBELL, Calif.–(BUSINESS WIRE)–Simpson Interventions, Inc., a pioneering medical technology company, specializing in cardiovascular interventional devices, today announced achievement of major development milestones. Its truly unique Acolyte™ Image-Guided Crossing and Re-Entry Catheter System has been granted an Investigational Device Exemption by […]
Microbot Medical® Concludes 2024 by Achieving Key Milestones Culminating in FDA Submission for the Commercialization of LIBERTY®
Company Shifts Focus to Preparing for Commercial Launch as it Enters 2025BRAINTREE, Mass., Dec. 30, 2024 (GLOBE NEWSWIRE) — Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic System, concludes 2024 with the achievement of several key milestones, including the recent FDA 510(k) submission for FDA commercial approval of LIBERTY®, which the company believes will position the Company for continued success in 2025. “As we entered 2024, the Company had three primary goals in our quest to ensure we are ready for the successful commercial launch of LIBERTY in 2025: 1) complete FDA 510(k) submission, 2) establish pre-commercial infrastructures, and 3) execute strategic initiatives to support future growth,” commented Harel Gadot, Chairman and Chief Executive Officer. “Thanks to the efforts of our team, coupled with a close collaboration with our internal and external stakeholders, I am very pleased with the progress we made throughout the year toward achieving these goals. I have a high level of confidence we will be positioned to meet our commercial objectives moving forward.” The following are the key milestones the Company has reported achieving during the past 12 months: Complete FDA 510(k) submission Received Investigational Drug Exemption (IDE) approval from the FDA to initiate the ACCESS-PVI pivotal human clinical trial.Successfully completed the ACCESS-PVI pivotal human clinical trial in three leading medical centers in the USA: Miami Baptist (Miami, FL), Memorial Sloan Kettering (NYC, NY) and Brigham & Women’s (Boston, MA).Successfully completed the substantial R&D testing required for FDA’s 510(k) submission, including biocompatibility, transportation validation, and usability testing, among others.Submitted 510(k) file to FDA for the commercialization of the LIBERTY® Endovascular Robotic System. Establish pre-commercial infrastructures Received ISO 13485 certification for our quality management system to support commercialization.Initiated inventory build-up while improving operational infrastructure.Submitted the ACCESS-PVI pivotal human clinical trial results to conferences in anticipation of sharing them publicly by leveraging these professional channels.Attended several endovascular medical conferences, including the Society of Interventional Radiology (SIR) and Cardiovascular and Interventional Radiological Society of Europe (CIRSE). Execute strategic initiatives to support future growth Completed Phase 1 and Phase 2 of the telesurgery collaboration with Corewell Health, culminating in a simulated procedure between two facilities located 5 miles apart.Entered into an agreement with Emory University to collaborate on the development of autonomous robotics. Based on these achievements, the Company believes it has laid the necessary groundwork to support its commercial objectives in 2025. The Company is anticipating the launch of LIBERTY in Q2 2025 in the U.S. and continuing its efforts to receive additional regulatory approval outside the U.S. to support future growth. About Microbot Medical® Microbot Medical Inc. (NASDAQ: MBOT) is a pre-commercial stage medical technology company with a vision to improve the quality of care for millions of patients and providers globally. The Company has developed the world’s first single-use, fully disposable endovascular robotic system, which aims to eliminate traditional barriers to accessing advanced robotic systems. Further information about Microbot Medical® is available at http://www.microbotmedical.com. Safe Harbor Statements to future financial and/or operating results, 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 “will,” “believes,” “plans,” “anticipates,” “expects” and “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, the Company’s need for and ability to obtain additional working capital to continue its transition to a commercially focused company, market conditions, risks inherent in the development and/or commercialization of the LIBERTY® Endovascular Robotic Surgical System, uncertainty in the results of regulatory pathways and regulatory approvals, including whether the FDA will grant 510(k) clearance to commercially market the LIBERTY® Endovascular Robotic Surgical System in the United States, disruptions resulting from new and ongoing hostilities between Israel and the Palestinians 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. Investor Contact: IR@microbotmedical.com
FDA Approves First Acellular Tissue Engineered Vessel to Treat Vascular Trauma in Extremities
SILVER SPRING, Md., Dec. 20, 2024 /PRNewswire/ — The U.S. Food and Drug Administration approved Symvess, the first acellular tissue engineered vessel indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization (restoration of blood flow)…
Microbot Medical® CEO Harel Gadot to Discuss Endovascular Robotics on Benzinga All Access
Livestream Interview Can be Viewed Today at 10:50am ET at Benzinga All Access Live