Endovascular Graft Systems: Letter to Health Care Providers – Type III Endoleaks Associated with Use [Posted 09/28/2017] AUDIENCE: Risk Manager, Surgery, Cardiology, Radiology ISSUE: The FDA is evaluating recent information regarding Type IIIa and IIIb endoleaks with the use of endovascular graft systems indicated for a procedure known as endovascular […]
Peripheral/Endo
Avinger Receives CE Marking Approval for In-Stent Restenosis Treatment Indication With Pantheris Image-Guided Atherectomy
REDWOOD CITY, Calif., Sept. 26, 2017 (GLOBE NEWSWIRE) — Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative treatments for Peripheral Artery Disease (PAD), today announced Conformité Européenne (CE) Marking approval for treating in-stent restenosis with the Pantheris® Lumivascular atherectomy system. In-stent restenosis occurs when a previously blocked artery treated with […]
TVA Medical Receives CE Mark For Next-Generation everlinQ 4 endoAVF System
AUSTIN, Texas, Sept. 27, 2017 /PRNewswire/ — TVA Medical, Inc., a medical device company developing innovative therapies for end-stage renal disease (ESRD), today announced that its everlinQTM 4 endoAVF System has received CE Mark in the European Union. The technology uses a 4 French catheter system with enhanced visual indicators to create hemodialysis access […]
Lombard Medical’s New Delivery System for Aorfix™ Endovascular Aortic Aneurysm Repair System Launched in Japan
OXFORDSHIRE, England–(BUSINESS WIRE)–Lombard Medical, Inc. (NASDAQ: EVAR), a developer, manufacturer and marketer of endovascular abdominal aortic aneurysm (AAA) endovascular repair products, today announced the full commercial launch in Japan of its new low-profile IntelliFlex™ LP delivery system for the Aorfix™ AAA system. The new delivery system, used to deliver Lombard’s […]
FDA Classifies Spectranetics’ Bridge Occlusion Balloon as Class I Recall
Bridge Occlusion Balloon Catheter Model 590-001 by Spectranetics: Class I Recall – Risk of Blocked Guidewire Lumen Preventing Balloon Utilization ISSUE: Spectranetics is recalling its Bridge Occlusion Balloon Catheter due to the possibility of a blocked guidewire lumen in some device units. If a device with a blocked guidewire lumen […]
Aortica Reports Successful Results Of First 30 Fenestrated EVAR Patients Using Automated Case Planning Software
9/25/2017 8:56:46 AM BELLEVUE, Wash.–(BUSINESS WIRE)–Aortica Corp. today announced that Dr. Benjamin Starnes, Chief of Vascular Surgery at the University of Washington (UW), has reported successful results for the first 30 patients undergoing Fenestrated Endovascular Aneurysm Repair (FEVAR) planned and performed using Aortica’s AORTAFIT™ automated case planning software. The cases […]
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 […]
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 […]
Argon Medical Sold for $850 M
Argo Medical sold to Chinese Device Maker looking to diversify it’s portfolio Chinese medical devices maker to buy US-based Argon for $850 mln HONG KONG, Sept 24 (Reuters) – China’s Shandong Weigao Group Medical Polymer Co Ltd has agreed to acquire US-based and unlisted Argon Medical Devices Holdings Inc for […]
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 […]



