Peripheral/Endo

Endospan Receives FDA IDE Approval to Initiate a Pivotal Study of the NEXUS™ Aortic Arch Stent Graft System

HERZLIA, Israel–(BUSINESS WIRE)–Endospan, a pioneer in off-the-shelf endovascular repair of aortic arch disease received approval from FDA of an investigational device exemption, or IDE, to start the TRIOMPHE study on the NEXUS™ Aortic Arch Stent Graft System (hereinafter referred to as NEXUSTM). Earlier this year, FDA granted NEXUSTM designation as a […]

Transit Scientific Announces First Worldwide Cases Performed with XO Cross Microcatheter Platform

First clinical cases completed using the new non-tapered, metal-alloy, peripheral catheter platform. PARK CITY, Utah, Aug. 17, 2020 /PRNewswire/ — Transit Scientific announced completion of the first clinical cases in the world using the XO Cross® Microcatheter platform. Dr. James McGuckin of the Lehigh Valley Vascular Institute (LVVI) performed the procedures using the XO Cross […]

AngioDynamics Announces First Patient Enrolled in PATHFINDER I Registry Examining Long-Term Effectiveness and Safety of Auryon Atherectomy System

LATHAM, N.Y.–(BUSINESS WIRE)–AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, today announced the enrollment of the first patient in the PATHFINDER I: Post-Market Registry (PATHFINDER I-Registry, EX-PAD-05). The PATHFINDER I Registry is a pilot study to evaluate […]

JanOne Completes Stable Formulation of JAN101 in Preparation for Its First GMP Manufacturing Batch to Support Upcoming Clinical Trials

JAN101 formulation ready for Phase 2b peripheral artery disease trials and for potential treatment of COVID-19 vascular inflammation LAS VEGAS, Aug. 11, 2020 /PRNewswire/ — JanOne Inc. (Nasdaq: JAN), a company focused on bringing treatments to market for conditions that cause severe pain and drugs with non-addictive, pain-relieving properties, together with its manufacturing partner, […]

Surmodics Receives FDA 510(k) Clearance for Sublime™ Radial Access 0.014 RX PTA Dilatation Catheter

Device designed to treat below-the-knee vessels from the radial arteries with industry’s longest (250 cm) working length EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance […]

JanOne Engages CATO SMS, a World-Leading CRO, to Assist in the Development of JAN101 to Treat COVID-19 Vascular Complications

Study to Explore JAN101’s Potential to Treat Ischemia¹ and Endothelial dysfunction² in COVID-19 patients. LAS VEGAS, Aug. 6, 2020 /PRNewswire/ — JanOne Inc. (Nasdaq: JAN), a company focused on bringing treatments to market for conditions that cause severe pain and drugs with non-addictive, pain-relieving properties, has entered into an agreement with CATO SMS, a […]

Endologix Receives CE Mark for ALTO Abdominal Stent Graft System

IRVINE, Calif.–(BUSINESS WIRE)–Transforming the treatment of aortic disorders, Endologix® Inc. (OTC: ELGXQ) (“Endologix” or the “Company”), today announced that it has received a CE Mark for the ALTO™ Abdominal Stent Graft System (ALTO). “We are very excited to receive a CE Mark for the ALTO system, that has been achieved through […]

JanOne Changes Internal Drug Candidate Name from TV1001SR to JAN101

LAS VEGAS, Aug. 4, 2020 /PRNewswire/ — JanOne Inc. (Nasdaq: JAN), a company focused on bringing treatments to market for conditions that cause severe pain and drugs with non-addictive, pain-relieving properties, announces a internal name change for its current drug candidate from TV1001SR to JAN101, soon to enter Phase 2b clinical trials as a potential treatment Peripheral […]

Endologix Announces First Commercial Implant of ALTO Abdominal Stent Graft System & Official Start of U.S. Commercial Release

IRVINE, Calif.–(BUSINESS WIRE)–Transforming the treatment of aortic disorders, Endologix® Inc. (OTC: ELGXQ) (“Endologix” or the “Company”), today announced the first commercial implant and the U.S. commercial release of its recently FDA-approved ALTO® endograft for the treatment of abdominal aortic aneurysms (AAA). “ALTO represents a differentiation from traditional endovascular aneurysm repair (EVAR) and, […]

Cardiovascular Systems Presents REACH PVI Study at the New Cardiovascular Horizons Conference

ST. PAUL, Minn.–(BUSINESS WIRE)–Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, today announced that the results from its REACH PVI study were presented at the New Cardiovascular Horizons (NCVH) Conference. This study prospectively […]