Peripheral/Endo

Avinger Announces 510(k) Filing for New Lightbox 3 Imaging Console

Smaller Footprint, Improved User Experience and Lower Cost to Drive Adoption REDWOOD CITY, CA / ACCESSWIRE / August 9, 2021 / Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today announced the submission […]

Fist Assist Devices, LLC Announces Completion of the Non-Significant Risk FACT Trial

Significant Superficial Arm Vein Dilation Reported with the FA-1 Device LOS ALTOS HILLS, Calif.–(BUSINESS WIRE)–Fist Assist Devices, LLC, announces completion of the non-significant risk FACT Trial (Fist Assist Clinical Trial). FACT evaluated the use of an intermittent pneumatic compression device, model FA-1, that was developed by Fist Assist Devices, to […]

Boston Scientific Initiates Randomized Controlled Trial for the EkoSonic™ Endovascular System

Study is first to compare interventional therapy in combination with anticoagulation to anticoagulation alone for treatment of pulmonary embolism MARLBOROUGH, Mass., Aug. 4, 2021 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) has commenced enrollment in the HI-PEITHO clinical trial, a collaborative research study with the Pulmonary Embolism Response Team (PERT) Consortium and the […]

Abbott Receives FDA Clearance for its Imaging Technology Using Artificial Intelligence for Vessels in the Heart

– Ultreon™ 1.0 Software, the first-of-its-kind imaging software, merges optical coherence tomography with the power of automation using Artificial Intelligence – The new intuitive interface provides step-by-step guidance to enhance ease of use – When combined with Abbott’s Dragonfly OpStar™ imaging catheter and PressureWire X™, the platform provides physicians with […]

Artio Medical Successfully Completes Enrollment of First-in-Human Trial Investigating the Amplifi™ Vein Dilation System

Novel vein dilation system aims to improve vascular access for hemodialysis patients Prairie Village, KS – July 14, 2021 – Artio Medical, Inc., a medical device company developing innovative products for the peripheral vascular, neurovascular, and structural heart markets, announced today it has completed enrollment in its first-in-human study evaluating the […]

Surmodics Announces Successful First Patient Use of Pounce™ Thrombectomy System

Standalone arterial mechanical thrombectomy device removes 30 cm of subacute thrombus in first clinical case 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, today announced that J. Michael Bacharach, MD, vascular interventionalist/cardiologist at North Central […]

InspireMD Enrolls and Treats First Patients at Ballad Health System in U.S. Registration C-Guardian Clinical Trial of CGuard EPS

TEL AVIV, Israel, July 23, 2021 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) device for the treatment of Carotid Artery Disease (CAD) and stroke prevention, today announces the initiation of enrollment and successful completion of the first cases of the Company’s […]

JanOne Selects CPC Clinical Research as Trial Manager for Phase 2b Study of JAN101 for Peripheral Artery Disease Patients

CPC to Manage Planning, Organization, and Day-to-Day Execution of the Trial LAS VEGAS, July 22, 2021 /PRNewswire/ — JanOne Inc. (Nasdaq: JAN), a company focused on developing treatments for conditions that cause severe pain and drugs with non-addictive, pain-relieving properties, today announced that it has selected CPC Clinical Research (CPC), a full-service academic research organization […]

Endologix LLC Receives FDA Breakthrough Device Designation for ChEVAS™ System

Investigational EVAS System Designed for Patients with Complex Abdominal Aortic Aneurysm IRVINE, Calif.–(BUSINESS WIRE)–Endologix LLC, a leader in the treatment of vascular disease, today announced the company’s ChEVAS™ (Chimney EndoVascular Aneurysm Sealing) System has been granted a Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). The ChEVAS […]

Vivasure Medical Announces Development of Sutureless Venous Closure Device for Use in Percutaneous Transcatheter Procedures

Investigational PerQseal Blue designed to be the world’s first and only fully absorbable device for large-bore venous closure Development program funded by €2.5 million grant awarded by the European Innovation Council Accelerator GALWAY, Ireland–(BUSINESS WIRE)–Vivasure Medical®, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced its development […]