Other News

Reflow Medical Announces 510(k) Clearance to Market Wingman Crossing Catheter for Coronary Indication

SAN CLEMENTE, Calif.–(BUSINESS WIRE)–Reflow Medical, Inc., a developer and innovator of crossing and support catheters for use in the treatment of occlusive cardiovascular disease, announced that the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Wingman14C Crossing Catheter for use in conjunction […]

TherOx Announces Its PMA Application for AMI Therapy System is Accepted for Filing by FDA

IRVINE, Calif.–(BUSINESS WIRE)–TherOx, Inc., a privately held medical device company focused on improving treatment of Acute Myocardial Infarction (AMI), announced that the U.S. Food and Drug Administration (FDA) has accepted the Premarket Approval (PMA) application for its Supersaturated Oxygen (SSO2) Therapy system. The second-generation SSO2 Therapy system is designed to reduce […]

BioStable Science & Engineering Announces the First Commercial Use of the HAART 200™ Aortic Annuloplasty Device

AUSTIN, Texas–(BUSINESS WIRE)–BioStable Science & Engineering, Inc. announced today the first commercial use of the HAART 200 Aortic Annuloplasty Device in the U.S. by doctors at the West Virginia University (WVU) Heart and Vascular Institute in Morgantown, West Virginia. Drs. Lawrence Wei, Vinay Badhwar and J. Scott Rankin were the […]

MicroVention Celebrates Grand Opening Of New Worldwide Innovation Center In Aliso Viejo, California

ALISO VIEJO, Calif., Sept. 26, 2017 /PRNewswire/ — MicroVention, a wholly owned subsidiary of Terumo Corporation and a global neurovascular company, today announced that the Grand Opening of its New Innovation Center was held on Monday, September 25. The opening of the new facility, located in the heart of the Summit Office Campus, also […]

W. L. Gore & Associates Completes Patient Enrollment In U.S. Pivotal Clinical Study Of GORE CARDIOFORM ASD Occluder

FLAGSTAFF, Ariz.–(BUSINESS WIRE)–W. L. Gore & Associates, Inc. (Gore) has completed enrollment for the pivotal phase of the Gore ASSURED Clinical Study. This investigational device exemption (IDE) trial is researching the new GORE®CARDIOFORM ASD Occluder for the interventional closure of Atrial Septal Defects (ASDs), sized 8 to 35 mm. The […]

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 […]

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 […]