The Latest Cardiac and Vascular News
IRVINE, Calif., Sept. 12, 2018 (GLOBE NEWSWIRE) — Hancock Jaffe Laboratories, Inc. (Nasdaq: HJLI, HJLIW), a company specializing in medical devices that restore cardiac and vascular health, announced today that the Journal of Vascular Surgery Venous and Lymphatic Disorders published an article on present and future options for treating deep vein disease, […]
BLOOMINGTON, Ind.–(BUSINESS WIRE)–Cook Medical today announced that it received a close-out letter from the U.S. Food and Drug Administration resolving a 2014 warning letter for processes related to the quality system at the company’s manufacturing facility in Bloomington, Indiana. The resolution was a direct result of countless hours of hard […]
MOUNTAIN VIEW, Calif.–(BUSINESS WIRE)–Vascular Dynamics, Inc. (VDI), a privately held medical device company focused on innovative, minimally invasive device-based solutions for cardiovascular conditions, today announced enrollment of the first patients in an FDA-approved best-in-class pivotal clinical trial. The CALM-2 study is designed to establish safety and efficacy of the novel […]
KIRKLAND, Wash., Aug. 27, 2018 /PRNewswire/ — Prevencio, Inc. today announces data demonstrating its HART PAD™test accurately diagnoses peripheral artery disease (PAD) in diabetes mellitus (DM) patients, a patient population in which PAD prevalence has traditionally been difficult to assess. Researchers believe these important findings, presented August 25 at the 2018 European Society of Cardiology […]
FLAGSTAFF, Ariz.–(BUSINESS WIRE)–W. L. Gore & Associates, Inc. (Gore) today announced the first implant in conjunction with the Gore ARISE Study of the GORE® Ascending Stent Graft, an investigational device and the only endovascular stent graft specifically designed to treat Type A dissections of the ascending aorta. The successful procedure took place […]
FLAGSTAFF, Ariz.–(BUSINESS WIRE)–W. L. Gore & Associates, Inc. (Gore) announced FDA 510(k) clearance, approval from the Japanese Ministry of Health, Labour, and Welfare, and receipt of CE Mark for the innovative GORE® Molding & Occlusion Balloon, a compliant polyurethane balloon catheter designed in close collaboration with clinicians to assist in the expansion […]
TEL AVIV, Israel, Aug. 20, 2018 /PRNewswire/ — Vascular Graft Solutions reports the first clinical use of its FRAME external support technology for aneurysm repair in high flow arteriovenous (AV) fistulas. The first 5 cases were performed by Dr. Vladimir Matoussevitch from Cologne University Hospital in Germany. “Autogenous AV fistula access for hemodialysis is a […]
SAN JOSE, Calif.–(BUSINESS WIRE)–NuCryo Vascular today announced that the company has signed a commercialization agreement with Lokai Medical, a specialty distributor of coronary/peripheral and interventional devices, to distribute the PolarCath™ Balloon Dilatation System in the United States. Balloon Cryoplasty® has been shown in clinical studies and in everyday procedures to be […]
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, presented two-year outcomes from its LIBERTY 360° study in a late-breaking presentation at the 2018 Amputation Prevention Symposium (AMP) in Chicago. The […]
BLOOMINGTON, Ind.–(BUSINESS WIRE)–Cook Medical has introduced the 140 mm-length Zilver® PTX® Drug-Eluting Peripheral Stent in both 6 and 7 mm diameters in the U.S. The longer length comes after an expanded indication approval by FDA to treat total lesion lengths up to 300 mm per patient. In addition, the product […]
