Peripheral/Endo

Instylla First-In-Human Clinical Trial Published Results Demonstrate Technical Success and Persistent Embolization Across All Patients

Prospective multicenter study evaluated the safety and efficacy of a PEG-based liquid embolic in treating hypervascular tumors BEDFORD, Mass., March 15, 2022 /PRNewswire/ — Instylla, Inc., a privately held company developing next-generation liquid embolics for peripheral vascular embolotherapy, today announced the publication of resultsi from the first-in-human clinical trial of Embrace™ Hydrogel Embolic System (HES) […]

LimFlow Completes Enrollment in PROMISE II U.S. Pivotal Trial of Breakthrough Device Designed to Prevent Amputations in No-Option Patients With Chronic Limb-Threatening Ischemia

PARIS–(BUSINESS WIRE)–LimFlow SA, a pioneer in the development of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), announced today that it has completed patient enrollment in the PROMISE II pivotal trial of the LimFlow System. The LimFlow System is designed […]

Fist Assist Devices, LLC Announces Australian Distribution Deal and Sales Launch

Regional Health Care Group Selected For Commercialization in Australian Market. LAS VEGAS–(BUSINESS WIRE)–Fist Assist Devices, LLC, announces a three-year affiliation with Regional Health Care Group to commercialize and launch sales of the Fist Assist Model FA-1 device in Australia and New Zealand. The Fist Assist Model FA-1 is a wearable, […]

S.M.A.R.T. RADIANZ™ Vascular Stent System Approved for Transradial Use in the U.S.

Completes the RADIANZ Radial Peripheral System™; signals Cordis’ renewed investment in innovation MIAMI LAKES, Fla., March 10, 2022 /PRNewswire/ — Cordis, a global cardiovascular technology company, today announced that the U.S. Food and Drug Administration (FDA) has approved the S.M.A.R.T. RADIANZ™ Vascular Stent System, a self-expanding stent purposefully engineered for radial peripheral procedures. […]

Cardiovascular Systems, Inc. Announces First In-Human Experience With Peripheral Everolimus Drug-Coated Balloon

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, announced today the start of enrollment in a first in-human trial of the peripheral everolimus drug-coated balloon (DCB) being developed by Chansu […]

Long-term Device Benefits Demonstrated in the Largest VasQ™ External Support Forearm Fistula Real-World Experience Published To Date

TEL AVIV, ISRAEL, March 9, 2022 /PRNewswire/ — Dr. Robert Shahverdyan, Head of Vascular Access Center at Asklepios Klinik Barmbek of Hamburg, Germany, in partnership with Dr. Dirk Hentschel, President-Elect of VASA and Interventional Nephrologist at Brigham and Women’s Hospital of Boston, MA, have recently published a retrospective analysis of 150 consecutive radiocephalic (forearm) fistula VasQ™ External Support […]

Avinger Announces Successful Completion of First Cases with the Lightbox 3 Next Generation Imaging Console

REDWOOD CITY, CA / ACCESSWIRE / February 28, 2022 / 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 that physicians in the U.S. have successfully completed first cases with its new […]

Clinical Study using QuantaFlo® published in Peer-Reviewed Journal of Vascular Surgery

Results show a positive screening of previously undetected PAD was independently associated with short-term and long-term increased risks for mortality and major adverse cardiovascular events SANTA CLARA, Calif., March 1, 2022 /PRNewswire/ — Semler Scientific, Inc. (Nasdaq: SMLR), a company that provides technology solutions to improve the clinical effectiveness and efficiency of healthcare providers, […]

Ra Medical Systems Files 510(k) Application for the DABRA Catheter with Braided Overjacket and Six-Month Shelf Life

CARLSBAD, Calif.–(BUSINESS WIRE)–Ra Medical Systems, Inc. (NYSE American: RMED), a medical device company focusing on developing its excimer laser system to treat vascular diseases, announces the filing of a 510(k) application with the U.S. Food and Drug Administration (FDA) for the company’s next-generation DABRA catheter with a braided overjacket and […]