The Latest Cardiac and Vascular News
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 […]
MARLBOROUGH, Mass., Aug. 8, 2018 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) today announced it has signed an agreement to acquire VENITI, Inc., a privately-held company in Fremont, California which has developed and commercialized the VICI VENOUS STENT® System for treating venous obstructive disease. Boston Scientific has been an investor in VENITI since 2016 and currently […]
