First U.S. Patient Receives GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL

FLAGSTAFF, Ariz.–(BUSINESS WIRE)–W. L. Gore & Associates, Inc. (Gore) announces the first U.S. implant of the GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System. The successful procedure was performed by William Jordan, M.D., chief of the Division of Vascular Surgery and Bradley Leshnower, M.D., cardiothoracic surgeon, at the Emory […]

Micro Medical Solutions Receives FDA IDE Approval for Pivotal Clinical Trial of MicroStent

WILMINGTON, Mass., June 24, 2019 /PRNewswire/ — Micro Medical Solutions (MMS), an innovator in the field of microvascular interventions that improve clinical outcomes and quality of life, announced today that it has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA). IDE approval allows MMS to initiate […]

BD Statement on FDA Circulatory System Devices Panel Regarding Paclitaxel-Coated Devices

FRANKLIN LAKES, N.J., June 20, 2019 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today issued the following statement following the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting related to the potential increase in mortality associated with […]

Ra Medical Clinical Study Aims to Show DABRA Keeps Arteries Healthy Longer

CARLSBAD, Calif.–(BUSINESS WIRE)–Ra Medical Systems, Inc. (NYSE: RMED) is conducting a study to demonstrate the DABRA Excimer Laser System delivers effective, long lasting results and a low reintervention rate for patients with peripheral artery disease (PAD). The study will gather data two years post-treatment in up to 2,500 patients. “Restenosis, or […]

Journal of Endovascular Therapy Publishes Peer Reviewed Article Underscoring the Clinical Impact of Post-Angioplasty Dissections

WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today welcomed the peer-reviewed publication, “Dissections After Infrainguinal Percutaneous Transluminal Angioplasty (PTA): Systematic Review and Current State of Clinical Evidence” currently available online, with the print article scheduled to be published in the August issue […]

TCAR Achieves Favorable Outcomes vs. Carotid Endarterectomy in Patients with Carotid Artery Disease

Updated Results of TCAR Surveillance Project Presented at Society for Vascular Surgery Vascular Annual Meeting NATIONAL HARBOR, Md., June 13, 2019 (GLOBE NEWSWIRE) — Silk Road Medical, Inc. (SILK), a company focused on reducing the risk of stroke and its devastating impact, today announced the presentation of real-world data for the […]

Cardiovascular Systems, Inc. Announces First Patient Enrolled in REACH PVI Clinical Study

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 first patient was enrolled in the REACH PVI study. The purpose of this study is to prospectively evaluate acute […]

Endologix Announces Reinstatement of CE Mark for its Nellix EndoVascular Aneurysm Sealing System

IRVINE, Calif.–(BUSINESS WIRE)–Endologix® Inc. (Nasdaq: ELGX), a developer and marketer of innovative treatments for aortic disorders, announced today that the EC Certificate of Conformity (CE Mark) for the Nellix EndoVascular Aneurysm Sealing System (Nellix System) has been reinstated by GMED, the EU Notified Body for the Nellix System. The reinstatement […]

Silk Road Medical Announces Key TCAR Presentations at the Society for Vascular Surgery 2019 Vascular Annual Meeting

Results Include Data from SVS TCAR Surveillance Project and ROADSTER-2 Study SUNNYVALE, Calif. – June 4, 2019 – Silk Road Medical, Inc. (Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, today announced key data from the SVS TCAR Surveillance Project and ROADSTER-2 study […]