Cook said to be recalling this device because of blood clots that can form within the graft after implantation. Zenith Alpha Thoracic Endovascular Graft by Cook Medical: Class I Recall – Potential Formation of Thrombus Inside Device AUDIENCE: Risk Manager, Cardiology, Surgery, Patient ISSUE: Cook Medical Inc. is recalling the […]
Author: Ken Dropiewski
BioStable Science & Engineering Announces FDA Clearance of the HAART™ 200 Aortic Annuloplasty Device for Bicuspid Aortic Valve Repair
AUSTIN, Texas–(BUSINESS WIRE)–BioStable Science & Engineering, Inc. announced today it has received FDA market clearance for the HAART 200 Aortic Annuloplasty Device, the first and only annuloplasty device designed specifically for bicuspid aortic valve repair. With FDA clearance of both the HAART 300 and HAART 200 Aortic Annuloplasty Devices, BioStable […]
VentureMed Group Raises $15 Million Series B Equity Financing
TOLEDO, Ohio, Aug. 15, 2017 /PRNewswire/ — VentureMed Group®, Inc., (“VMG” or the “Company”) a medical device company developing and commercializing next-generation endovascular products to treat patients suffering from peripheral artery disease (PAD), today announced it had raised $15 million in new equity financing. The Series B Round was led by new investor Endeavour […]
Vascular Dynamics, Inc. Announces FDA Approval To Initiate CALM 2 Trial For Mobiushd System For The Treatment Of Resistant Hypertension
MOUNTAIN VIEW, Calif., Aug. 15, 2017 (GLOBE NEWSWIRE) — Vascular Dynamics, Inc., (VDI) a privately held medical device company developing novel solutions for the treatment of hypertension, today announces that the United States Food and Drug Administration (FDA) has approved the company’s Investigational Device Exemption (IDE) application to initiate its […]
Medtronic Announces Randomized Global Resolute Onyx(TM) DES One-Month Dual Antiplatelet Therapy Study to Address Critical Unanswered Question in Interventional Cardiology
DUBLIN- August 14, 2017 – Medtronic plc (NYSE: MDT) today announced a global randomized clinical trial that will evaluate one-month dual antiplatelet therapy (DAPT) – the combination of aspirin and an anti-clotting medication – in patients implanted with the Resolute Onyx(TM) Drug-Eluting Stent (DES) during percutaneous coronary intervention (PCI). Designed to […]
Abbott Leads Way in First Clinical Trial of Minimally Invasive Clip-Based Repair System for Leaky Tricuspid Heart Valves
ABBOTT PARK, Ill., Aug. 9, 2017 — Abbott today announced that the first patient has been enrolled in a clinical study to evaluate a minimally invasive clip-based repair system for treating people with moderate or severe tricuspid regurgitation (TR), a common condition affecting the right side of the heart. The […]
Spectranetics Announces Fundamental Change, Make-Whole Adjustment Event, Share Exchange Event and Supplemental Indenture for 2.625% Convertible Senior Notes due 2034
COLORADO SPRINGS, Colo., Aug. 10, 2017 (GLOBE NEWSWIRE) — The Spectranetics Corporation (NASDAQ:SPNC) (“the Company”), a developer and manufacturer of single-use medical devices used in minimally invasive procedures within the cardiovascular system, today announced the occurrence of a Fundamental Change, Make-Whole Adjustment Event and Share Exchange Event, and the execution […]
Osprey Medical Improving Cardiac Diagnostics, Raises Capital and Soaring Sales
Osprey Medical (ASX:OSP) based in Minnetonka, MN continues to make strong progress toward their mission of making coronary angiography (heart x-ray imaging) safer for patients with poor kidney function. They are rapidly growing US sales with a direct sales force; in Q2 2017 sales were up 240% over the prior […]
First Cancer, Now Heart Disease…Color Genomics
A New Heart Disease Test Flings Color Genomics Into A Battle About Genetics In Medicine Matthew Herper , Forbes Staff – covering science and medicine. Color Genomics, a Burlingame, Calif.-based startup that has made a name for itself by selling tests for genes that dramatically raise the risk of cancer, is […]
Cardiovascular Systems Releases Data on Peripheral Liberty Trial
This study recaps one year and 1200 patients including use of the Diamond Back 360. Cardiovascular Systems touts 1-year, sub-analysis data from Liberty PVI study AUGUST 10, 2017 BY FINK DENSFORD, MassDevice Cardiovascular Systems (NSDQ:CSII) today released both 1-year and a sub-analysis results from the Liberty 360 clinical trial of peripheral interventions, including those […]



