Other News

Protembis Announces Successful First-in-Human Use of Its ProtEmbo® Cerebral Protection System in European Trial

AACHEN, Germany–(BUSINESS WIRE)–Protembis GmbH, a privately held medical device company, announced today the first clinical applications of its ProtEmbo® Cerebral Protection System to complement a transcatheter aortic valve replacement (TAVR) procedure. The ProtEmbo® System is an intra-aortic filter device that deflects embolic material arising during TAVR away from the brain. Darren Mylotte, […]

Spectranetics Recalls Bridge Occlusion Balloons

Philips subsidiary Spectranetics recalls Bridge occlusion balloon AUGUST 31, 2017 BY BRAD PERRIELLO , MassDevice Royal Philips (NYSE:PHG) subsidiary Spectranetics recalled its Bridge occlusion balloon after receiving reports of blocked guidewire lumens. The Bridge device is used to temporarily block the superior vena cava for emergency control of hemorrhage. Spectranetics said the August 25 recall was […]

HeartFlow Announces Positive Medical Coverage Decisions on Non-Invasive HeartFlow® FFRct Analysis from Anthem Blue Cross Blue Shield, Blue Shield of California and Blue Cross and Blue Shield of Alabama

REDWOOD CITY, Calif.–(BUSINESS WIRE)–HeartFlow, Inc. today announced that Anthem Blue Cross Blue Shield, Blue Shield of California, and Blue Cross and Blue Shield of Alabama have each issued a positive medical policy for the HeartFlow® FFRct Analysis, a first-of-its-kind noninvasive technology that helps clinicians diagnose and treat patients with suspected coronary artery […]

PQ Bypass Earns Frost & Sullivan’s European Technology Innovation Award for Its Proprietary DETOUR System for Percutaneous Bypass

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 […]

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. […]

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 […]