LONDON, Aug. 31, 2017 /PRNewswire/ — Frost & Sullivan is pleased to recognize PQ Bypass with the 2017 European PAD Interventions Technology Innovation Award. PQ Bypass’ DETOUR System is a minimally invasive technology that enables physicians to re-direct, or detour, blood flow around extremely long blockages in the upper leg arteries to restore […]
Other News
Balloon Expandable Stents OUT for Treatment of Peripheral Vascular Disease?
by Ken Dropiewski, Prime-Core Executive Search (ken@prime-core.com) Balloon expandable stents have been the mainstay in treating blockages in the iliac arteries for years. However, recent data suggests a change is in order. According to researchers who recently compared the two versions in a large group of patients being treated in […]
ABBOTT ISSUES NEW UPDATES FOR IMPLANTED CARDIAC DEVICES
ABBOTT PARK, Ill., Aug. 29, 2017 – Today, Abbott notified physicians of updates to its implantable pacemakers and defibrillators as part of its ongoing commitment to continuously improve patient care. The new device updates include a Battery Performance Alert for our implantable cardioverter defibrillators (ICDs) that provides physicians with earlier […]
Abbott initiates ground-breaking U.S. pivotal study of AMPLATZER device to correct common congenital heart defect in newborns
ABBOTT PARK, Ill., Aug. 30, 2017 /PRNewswire/ — Abbott (NYSE: ABT) today announced it has initiated a U.S. pivotal clinical study evaluating the safety and effectiveness of a modified version of its AMPLATZER™ device designed to correct a common congenital heart defect that occurs in approximately 80,000 i,ii pre-term infants in the U.S. each year. […]
FDA to increase User Fees to Review Products
Looks like the FDA will be increasing the user fees for fiscal 2018 Most FDA user fees set to rise 33% AUGUST 30, 2017 BY BRAD PERRIELLO, MassDevice The latest user fee authorization enacted last week has most of the fees medical device makers pay the FDA to review its products rising […]
ESC Congress 2017: BIOTRONIK’s Orsiro Drug-Eluting Stent Outperforms Xience in BIOFLOW-V Trial
Landmark Data Published by The Lancet Demonstrates Statistically Significant Lower Event Rates with Orsiro BARCELONA, Spain, August 28, 2017 – BIOTRONIK today announced data from the BIOFLOW-V randomized trial comparing Orsiro1 and Xience2 drug-eluting stents (DES) with 12-month target lesion failure (TLF) as the primary endpoint proving non-inferiority. Results presented at the […]
Aziyo Completes Enrollment in Prospective Post Market Study of CanGaroo ECM Envelope
SILVER SPRING, Md.–(BUSINESS WIRE)–Aziyo Biologics, Inc. a fully integrated regenerative medicine company, today announced completion of patient enrollment in SECURE, a prospective post market study of 1,000 patients treated with CanGaroo® ECM® Envelope in conjunction with cardiac implantable electronic device (CIED) placement. The CanGaroo ECM Envelope is intended to securely hold a […]
Abiomed Announces Resignation of Chief Financial Officer and Welcomes Back Former Chief Financial Officer as Consultant
DANVERS, Mass., Aug. 28, 2017 (GLOBE NEWSWIRE) — Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart support and recovery technologies, announced today that it has accepted the resignation of its Chief Financial Officer, Michael Tomsicek, effective August 24, 2017. After two years, Mr. Tomsicek is leaving the Company to pursue other […]
Resonetics Acquires Aduro Laser, Adds Disruptive Manufacturing Capability for Laser Cut Tubing
NASHUA, N.H., Aug. 28, 2017 /PRNewswire/ — Resonetics announced today its acquisition of Aduro Laser, an emerging leader in laser processing of tubular components for the medical device industry. In just four years, Aduro has established an innovative business model and proprietary technology to shorten lead times dramatically, enabling customers to iterate rapidly and […]
Medtronic Plans for Renal Denervation Pivotal Trial After New Study Shows Significant Blood Pressure Reductions
Published Simultaneously in The Lancet, the Late-Breaking SPYRAL HTN-OFF MED Study at ESC Successfully Isolates RDN Treatment Effect to Show Compelling Efficacy and Safety of Hypertension Procedure DUBLIN and BARCELONA – August 28, 2017 – Medtronic plc (NYSE:MDT) today announced its intent to move forward with a new renal denervation pivotal trial […]



