Peripheral/Endo

Enrollment Completed in Reflow Medical’s DEEPER OUS Clinical Trial

SAN CLEMENTE, Calif.–(BUSINESS WIRE)–Reflow Medical, Inc. announces that it has completed patient enrollment in the DEEPER OUS clinical trial (NCT03807531) for the company’s Temporary Spur Stent System, a novel device that features a retrievable stent designed for complex infrapopliteal disease. 106 patients have now been enrolled in the prospective, nonrandomized […]

Magneto Thrombectomy Solutions Announces Successful First-in-Human Results for Treatment of Pulmonary Embolism (PE)

– The eTrieve™ catheter for removing blood clots, based on electric fields, met safety and feasibility endpoints – Data, showing significant reduction RV/LV ratio and alleviation of PE associated symptoms, presented at Biomed Israel 2022 OR YEHUDA, Israel, May 10, 2022 /PRNewswire/ — Magneto Thrombectomy Solutions (Magneto), a medical devices company developing innovative thrombectomy solutions for the […]

Access Vascular Inc. Named 2022 MedTech Breakthrough Award Winner

Access Vascular’s transformational biomaterial catheters named “Best New Technology Solution” for ability to dramatically improve vascular access medical and economic outcomes BILLERICA, Mass., May 10, 2022 (GLOBE NEWSWIRE) — Access Vascular, Inc. (AVI) today announced it has been named “Best New Technology Solution – Drug Delivery” in the 2022 MedTech Breakthrough […]

Acer Therapeutics Announces Agreement with FDA on Special Protocol Assessment for its Phase 3 EDSIVO™ (celiprolol) Trial in Vascular Ehlers-Danlos Syndrome Patients

Phase 3 DiSCOVER clinical trial initiation expected by end of Q2 2022 NEWTON, Mass., May 09, 2022 (GLOBE NEWSWIRE) — Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs, today announced […]

Verve Therapeutics Reports Additional VERVE-101 and GalNAc-Lipid Nanoparticle Delivery Data in Non-Human Primates at TIDES USA 2022

VERVE-101 Preclinical Data Package Supports Company’s Global Development Strategy and Regulatory Submissions for Clinical Trials in Patients with HeFH Single Intravenous Infusion of VERVE-101 Clinical Formulation Led to Mean 68% Reduction in Plasma LDL-C in NHPs Out to One-Year with Good Tolerability; VERVE-101 Precursor Formulation Led to Durability of LDL-C […]

Access Vascular Receives FDA Clearance for HydroPICC® Biomaterial-Based Dual-Lumen Catheter

Single- and dual-lumen biomaterial catheters allow hospitals to reduce thrombosis and vascular access complications for majority of PICC applications BILLERICA, Mass., May 05, 2022 (GLOBE NEWSWIRE) — Access Vascular, Inc. (AVI) today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its HydroPICC® Dual-Lumen catheter. Designed […]

Silk Road Medical Announces FDA Approval of Expanded Indications for the ENROUTE® Transcarotid Stent System

SUNNYVALE, Calif., May 02, 2022 (GLOBE NEWSWIRE) — Silk Road Medical, Inc. (Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, today announced that that the U.S. Food and Drug Administration (FDA) approved expanded indications for the ENROUTE stent to include patients at standard […]

Biomerics Announces Image Guided Intervention (IGI) Division

SALT LAKE CITY, May 2, 2022 /PRNewswire/ — Biomerics, a leading vertically integrated contract manufacturer for the attractive interventional device market, announced the creation of a new division, Biomerics Image Guided Intervention (IGI). Biomerics’ IGI Division, headquartered in Salt Lake City, provides advanced image generation and processing technologies to enable real-time minimally invasive […]

VOTIS SUBDERMAL IMAGING TECHNOLOGIES, LTD. ANNOUNCES ENROLLMENT OF FIRST HUMAN SUBJECT IN PILOT FEASIBILITY STUDY OF PEDCHECK™ AT HADASSAH MEDICAL CENTER IN JERUSALEM

JERUSALEM, May 2, 2022 /PRNewswire/ — VOTIS Subdermal Imaging Technologies Ltd. announced today that it has enrolled the first patient in the feasibility study of its PedCheckTM device at Hadassah Medical Center in Jerusalem, Israel. The pilot study, entitled “The Use of Hemodynamic Occlusive Vascular Response (HOVR™) technology to Screen for Peripheral Arterial Disease (PAD)”, is intended to […]

Boston Scientific Receives FDA Clearance for the EMBOLD™ Fibered Detachable Coil

MARLBOROUGH, Mass., April 28, 2022 – Boston Scientific Corporation (NYSE: BSX) has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the EMBOLD™ Fibered Detachable Coil, which is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature. The first procedure using the device was performed this week […]