Other News

Boston Scientific (BSX) Nabs FDA OK for MRI Labeling on High-Voltage Devices, U.S. Launch of Resonate Devices

MARLBOROUGH, Mass., Sept. 25, 2017 /PRNewswire/ — Boston Scientific (NYSE: BSX) has launched the Resonate family of implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) systems featuring the HeartLogic Heart Failure Diagnostic to help physicians improve heart failure (HF) management. The new devices, which are approved by the U.S. Food […]

FDA OKs Abbott (ABT)’ MRI-Compatibility for the Company’s Ellipse ICD

ABBOTT PARK, Ill., Sept. 22, 2017 /PRNewswire/ — Abbott (NYSE: ABT) today announced U.S. Food and Drug Administration (FDA) approval for magnetic resonance (MR)-conditional labeling for one of Abbott’s most widely-used implantable cardioverter defibrillators (ICD) and associated high voltage leads. The approval of MR-conditional labeling for the Ellipse ICD with the Tendril MRI […]

InspireMD Announces Distribution Agreement For CGuard EPS In Portugal

TEL AVIV, ISRAEL–(Marketwired – September 21, 2017) – InspireMD, Inc. (NYSE MKT: NSPR) (NYSE American: NSPR) (NYSE MKT: NSPR.WS) (NYSE American: NSPR.WS) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced it has signed an agreement with Medicinália Cormédica MC Medical Lda, a […]

Medtronic (MDT) Announces Clinical Study To Evaluate The Corevalve Evolut PRO System In ‘Everyday’ Clinical Practice

DUBLIN – September 21, 2017 – Medtronic plc (NYSE: MDT) today announced a new post-market clinical study to evaluate its CoreValve(TM) Evolut(TM) PRO valve in everyday clinical practice. Studying patients with severe symptomatic aortic stenosis at an intermediate, high or extreme risk for open heart surgery, the FORWARD PRO Clinical Study […]

Endologix Announces CE Mark Approval For The Nellix Endovascular Aneurysm Sealing System With The Refined Indications For Use

9/21/2017 7:24:55 AM IRVINE, Calif.–(BUSINESS WIRE)–Endologix, Inc. (NASDAQ: ELGX), a developer and marketer of innovative treatments for aortic disorders, today announced the CE Mark approval for its Nellix® EndoVascular Aneurysm Sealing System (“Nellix”) with the refined Indications for Use (IFU). Nellix is being studied in the U.S. under an Investigational Device […]

Abiomed (ABMD) Receives FDA PMA Approval For Impella RP For Right Heart Failure

DANVERS, Mass., Sept. 20, 2017 (GLOBE NEWSWIRE) — Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart support and recovery technologies, today announced it has received U.S. Food and Drug Administration (FDA) pre-market approval (PMA) for the Impella RP® heart pump. Culminating from five years of research, this approval follows the […]

Lombard Medical (LMT.L) Appoints Jonathan Hornsby As Vice President, Sales & Marketing

OXFORDSHIRE, England–(BUSINESS WIRE)–Lombard Medical, Inc. (NASDAQ: EVAR), a developer, manufacturer and marketer of endovascular aortic aneurysm repair products, today announced the appointment of Jonathan Hornsby as Vice President, Sales & Marketing, effective immediately. Jonathan Hornsby brings over 20 years of experience in the endovascular aortic repair business. He has been […]

Shockwave Medical Shows Off Disrupt BTK Lithoplasty System Study Results

FREMONT, Calif.–(BUSINESS WIRE)–Shockwave Medical, a pioneer in the treatment of calcified cardiovascular disease, today reported positive results from the DISRUPT BTK Study, which were presented at the annual Cardiovascular and Interventional Radiological Society of Europe (CIRSE) congress in Copenhagen, Denmark. DISRUPT BTK, a prospective single arm study, evaluated the use […]