ISSUE: The FDA is providing information about the potential for increased image artifact associated with Magnetic Resonance Angiography (MRA) imaging for patient follow-up of certain post neurovascular embolization coil procedures. Neurovascular embolization coils are used in the treatment of brain aneurysms and other vascular abnormalities. These coils are prescription devices […]
Other News
United States Patent and Trademark Office Issues Multiple Patents on New Arterial & Venous Embolic Device to Control Bleeding, Seal Leaks, and De-Vascularize Tumors
PARK CITY, Utah–(BUSINESS WIRE)–The United States Patent & Trademark Office (USPTO) issued two new patents today for the GPX Embolic Particle device, a biocompatible catheter delivered embolic technology designed for use in arteries and veins. A scientific presentation of this vascular embolic device titled GPX: A New Proprietary In Situ […]
Industry Veteran Carrie Powers Joins CHF Solutions, Inc. as Vice President of Marketing
EDEN PRAIRIE, Minn., March 12, 2018 (GLOBE NEWSWIRE) — CHF Solutions, Inc. (NASDAQ:CHFS), today announces the appointment of Carrie Powers, RN, as vice president of marketing. Ms. Powers joins CHF Solutions with 12 years of leadership, management, and marketing experience within the interventional cardiology and interventional radiology markets. During her tenure […]
Endospan Appoints Kevin J. Mayberry as CEO
HERZLIA, Israel–(BUSINESS WIRE)–Endospan, a pioneer in off-the-shelf endovascular repair of Aortic Arch Disease including aneurysms and dissections, today announced that it has appointed Kevin J. Mayberry as Chief Executive Officer (CEO), effective immediately. He replaces Alon Shalev, who will continue as a director of Endospan. Previously, Mayberry served in various R&D and […]
James R. Tobin Joins Corindus Board of Directors
WALTHAM, Mass.–(BUSINESS WIRE)– Corindus Vascular Robotics, Inc. (NYSE American: CVRS), a leading developer of precision vascular robotics, today announced that James (Jim) Tobin has been appointed to its Board of Directors, effective immediately. President and Chief Executive Officer Mark Toland stated, “I am pleased to welcome Jim to our board of directors. […]
Reflow Medical announces enrollment of its first patients in the Wing-IT IDE clinical trial
San Clemente, Calif., March 12, 2018 /PRNewswire/ — Reflow Medical Inc., a developer of innovative medical devices to combat cardiovascular disease, announced that the first patients have been enrolled in a prospective, multi-center, non-randomized study intended to evaluate the ability of the Reflow Wingman Catheters to cross chronic total occlusions […]
PATIENT ENROLLMENT COMPLETED IN U.S. IDE STUDY OF THERMOCOOL SMARTTOUCH® SF CATHETER FOR TREATMENT OF PERSISTENT ATRIAL FIBRILLATION
IRVINE, CA, — March 13, 2018 — Johnson & Johnson Medical Devices Companies* announced today that Biosense Webster, Inc., a worldwide leader in the diagnosis and treatment of heart arrhythmias, has completed patient enrollment in its U.S. Investigational Device Exemption (IDE) study of the THERMOCOOL SMARTTOUCH® SF Catheter. The prospective, […]
BioVentrix Announces First Patient at Cardiovascular Institute of the South Successfully Treated in IDE Study of Revivent TC™ TransCatheter Ventricular Enhancement Treatment
SAN RAMON, Calif., and HOUMA, La., March 12, 2018 /PRNewswire/ — BioVentrix, Inc., a pioneer of technologies and procedures for less invasive treatment of heart failure (HF), today announced successful treatment of the first patient at the Cardiovascular Institute of the South in the ALIVE pivotal clinical trial. The trial is […]
Cleveland Clinic Study Affirms Accurate Detection of Atrial Fibrillation by KardiaBand for Apple Watch
ORLANDO, Fla., March 12, 2018 /PRNewswire/ — AliveCor, the leader in FDA-cleared personal electrocardiogram (ECG) technology, today announced findings from two new studies that further support the use of its portable ECG devices to provide groundbreaking health monitoring capabilities. A new Cleveland Clinic study — which marks the first time Apple […]
XableCath Granted United States Patent for its Peripheral Arterial Catheters
SALT LAKE CITY–(BUSINESS WIRE)– XableCath, Inc., innovators of products designed to aid in the treatment of peripheral artery disease (PAD), announced that it has been granted a second U.S. Patent, No. 9,826,995, covering its XableCath™ catheter. The patent specifically describes a catheter that controls tissue contact and has a rigid […]



