XableCath Receives Second FDA Clearance for Its Peripheral Arterial Catheters

SALT LAKE CITY–(BUSINESS WIRE)–XableCath, Inc., innovators of products designed to aid in the treatment of peripheral artery disease (PAD), announced that its second catheter, XableCath™ abrasion tip support catheter, was cleared by the FDA. The XableCath blunt tip catheter received FDA clearance at the end of 2017. This clearance gives […]

Avinger Receives FDA Clearance of Next Generation Pantheris Device

REDWOOD CITY, Calif., May 23, 2018 (GLOBE NEWSWIRE) — Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), announced today that the Company received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its next generation Pantheris® Lumivascular atherectomy system, the first-ever image-guided […]

FlowTriever System from Inari Medical Receives FDA 510(k) Clearance for Treatment of Pulmonary Embolism

IRVINE, Calif., May 21, 2018 /PRNewswire/ — Inari Medical, Inc., announced today the FlowTriever System has received FDA 510(k) clearance for the treatment of pulmonary embolism (“PE”). This clearance makes the FlowTriever System the first and only thrombectomy device cleared by the FDA for the treatment of PE.   The PE-specific clearance was based […]

Amgen Receives European Commission Approval For Repatha® (Evolocumab) To Prevent Heart Attack And Stroke In Adults With Established Cardiovascular Disease

THOUSAND OAKS, Calif., May 16, 2018 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced that the European Commission (EC) has approved a new indication in the Repatha® (evolocumab) label for adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering low-density lipoprotein cholesterol (LDL-C) levels. With the […]

Surmodics Acquires Thrombectomy Technology Assets from Embolitech, Strengthening Peripheral Vascular Whole-Product Solutions Portfolio

EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ: SRDX), a leading provider of medical device and in vitro diagnostic technologies to the healthcare industry, announced today it has reached an agreement with Embolitech to acquire an innovative thrombectomy platform technology and related intellectual property with broad potential peripheral vascular applications. Under the […]

Vesper Medical Completes $10.5 M Series A Financing to Drive Development of Next Generation Venous Stents

WAYNE, Pa.–(BUSINESS WIRE)–Vesper Medical, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced that it completed its Series A financing totaling $10.5 million. Major participants in the Series A financing included New Enterprise Associates and Quaker Partners. The financing occurred in two tranches and is […]

PlaqueTec Data Presented at EAS Show Lack of Correlation between Localised Coronary Artery Inflammatory Biomarker Expression and Systemic Elevation of Biomarkers including hsCRP

CAMBRIDGE, England–(BUSINESS WIRE)–Researchers from PlaqueTec Ltd. presented data suggesting that localised coronary inflammation may be independent of systemic elevation of inflammatory biomarkers such as high-sensitivity C reactive protein (hsCRP). The data, presented at the 86th European Atherosclerosis Society (EAS) Congress in Lisbon, Portugal, are based on analysis of blood samples obtained […]

FLEX Scoring Catheter Presented at 2018 Charing Cross International Symposium

TOLEDO, Ohio, May 7, 2018 /PRNewswire/ — VentureMed Group, Inc., a medical device company specializing in the development and commercialization of innovative and cost-effective devices for the endovascular treatment of peripheral arterial disease (PAD), presented a technical review of the FLEX Dynamic Scoring Catheter™ in the Innovations session of the conference, as […]