DEERFIELD, Ill.–(BUSINESS WIRE)–Baxter International, Inc. (NYSE: BAX), a global leader in sterile medication production and delivery, today announced the FDA approval of Bivalirudin in 0.9 percent Sodium Chloride Injection (bivalirudin). Bivalirudin is a specific and direct thrombin inhibitor indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI), a common […]
Author: Ken Dropiewski
Avinger Granted Continued Listing Decision From Nasdaq
REDWOOD CITY, Calif., Jan. 19, 2018 (GLOBE NEWSWIRE) — Avinger (NASDAQ:AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), announced today that the Company has received formal notification that the Nasdaq Hearings Panel (the “Panel”) has granted the Company’s request for the transfer of its listing from […]
Non-Culprit Lesions Cause 2x More Subsequent MIs than PCI’d Lesions
by Ken Dropiewski, Prime-Core Executive Search (ken@prime-core.com) A new study published in the Journal of the American Heart Association shows that AMIs following a percutaneous coronary intervention (PCI) is twice as likely to originate from untreated lesions versus previous stented lesions. Interesting since this information seems to differ from previous studies such as PROSPECT […]
Edwards Lifesciences To Host Earnings Conference Call On February 1, 2018
IRVINE, Calif., Jan. 18, 2018 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, plans to announce its operating results for the quarter ended December 31, 2017 after the market closes on Thursday, February 1, 2018, and will host a conference call at 5:00 p.m. […]
Texas Cardiac Arrhythmia Institute at St. David’s Medical Center First in Texas to Use New Smartphone Compatible, Insertable Cardiac Monitor
AUSTIN, Texas, Jan. 18, 2018 /PRNewswire/ — On Nov. 14, 2017, Texas Cardiac Arrhythmia Institute (TCAI) at St. David’s Medical Center became the first hospital in Texas—and among the first in the nation—to use the new smartphone compatible Confirm Rx™ Insertable Cardiac Monitor (ICM), the world’s first and only smartphone compatible ICM designed to help physicians […]
Cardiovascular Systems Expands Product Portfolio to Further Support Peripheral and Coronary Interventions
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, today announced two new partnerships broadening the company’s product portfolio. CSI is now the exclusive U.S. distributor of OrbusNeich balloon products. Additionally, the […]
BD Announces Completion of Enrollment in the Lutonix 014 Drug Coated Balloon Below-the-Knee Trial
FRANKLIN LAKES, N.J., Jan. 18, 2018 /PRNewswire/ — Becton, Dickinson and Company (NYSE: BDX), a leading global medical technology company, today announced the completion of enrollment in the Lutonix below-the-knee (BTK) trial and plans to submit a pre-market approval application in late 2018. The Lutonix BTK trial is a prospective, multicenter, randomized, […]
Bluegrass Vascular Announces Enrollment of First Patients in U.S. Pivotal Trial
SAN ANTONIO, Jan. 18, 2018 /PRNewswire/ — Bluegrass Vascular Technologies, a private medical technology company focused on innovating lifesaving devices and methods for vascular access, today announced the enrollment of its first patients in the SAVE-US (Surfacer® System to Facilitate Access in VEnous Occlusions – United States) pivotal trial. The SAVE-US clinical trial is a pre-market […]
Neovasc Reducer Featured in Live Case at Berlin Symposium
VANCOUVER, Jan. 18, 2018 /PRNewswire/ – Neovasc Inc. today reported its Neovasc Reducer™ (“Reducer”) was featured in a “live case” broadcast to more than 800 participants at the Kardiologie Symposium 2018 held in Berlin, Germany. The successful live case was performed by Dr. Spyrantis and Professor Banai in the Sana-Klinikum Lichtenberg. “The […]
FDA adds safety alert for Zoll LifeVest
Patient death prompts safety warning by FDA. Zoll LifeVest 4000 Wearable Cardioverter Defibrillator: FDA Safety Communication – Potential Lack of Treatment (Shock) Delivery Due to Device Failure by FDA.gov ISSUE: FDA is providing information and recommendations regarding the Zoll LifeVest 4000 due to concerns that the device may fail to […]



