Coronary/Structural Heart

FDA Green Lights ClearFlow’s FlowGlide Technology for Cardiac Surgery Patients

ANAHEIM, Calif.–(BUSINESS WIRE)–ClearFlow, Inc., a medical device company based in Anaheim, California, announced today that the United States Food & Drug Administration (FDA) has granted 510[k] clearance for the company’s proprietary FlowGlide™ Active Clearance Technology® System. “The new design helps resist kinks, and allows positioning of the catheters into harder-to-reach […]

San Diego’s REVA Medical Completes $34.6 Million Funding Round

SAN DIEGO, June 19, 2017 (GLOBE NEWSWIRE) — REVA Medical, Inc. (ASX:RVA) (“REVA” or the “Company”) announces that it has closed the second tranche and, therefore, has completed the financing transaction announced in April 2017 and approved by the Company’s shareholders on June 1, 2017. Completion occurred on June 16, […]

Mitralign Announces Enrollment of First European Subject in Transcatheter Tricuspid Repair Study Enrolled in SCOUT II Study with Trialign™ System for Transcatheter Tricuspid Repair

TEWKSBURY, Mass. & MILAN–(BUSINESS WIRE)–Mitralign Inc., an innovative developer of transcatheter tricuspid and mitral valve repair solutions, announced today the commencement of its SCOUT II study in Europe, with the Trialign System for the treatment of patients suffering from tricuspid regurgitation. “We are pleased to be the first center in […]

Abiomed (ABMD) Release: Heart Recovery Patients Visit Capitol Hill To Advocate For Lifesaving Cardiovascular Technology

WASHINGTON, June 09, 2017 (GLOBE NEWSWIRE) — Nineteen patients who benefitted from treatment with Abiomed’s Impella heart pumps traveled to Washington, D.C. on June 8, 2017, to meet with elected officials and participate in a Congressional Briefing hosted by the MedTech Caucus, which supports the development of innovative technology. This […]

St. John Hospital & Medical Center 1st in U.S. to Treat High Risk Patient with New Heart Stent and Pump

DETROIT, June 2, 2017 /PRNewswire-USNewswire/ — Heart care experts at St. John Hospital & Medical Center (SJH&MC) are the first in the country to treat a high risk patient with the use of a heart pump and newly approved heart stent technology. The procedure was performed by SJH&MC cardiologist, Antonious Attallah, […]

HeartFlow Names Healthcare Industry Veteran Michael Buck as Executive Vice President and Chief Commercial Officer

REDWOOD CITY, Calif.–(BUSINESS WIRE)–HeartFlow Inc. has announced the appointment of seasoned healthcare leader Michael Buck as executive vice president and chief commercial officer. Effective immediately, Buck will be responsible for expanding and accelerating global market adoption of the company’s HeartFlow® FFRct Analysis, the first noninvasive technology to provide insight into […]

Will iFR and OCT be the New Gold Standard for Pre-Intervention Analysis?

By Ken Dropiewski A new technique may soon bring even more precision to interventional cardiology. Patients with known coronary lesions are being urged to undergo two additional tests before intervention. These diagnostic tools are Instant Wave-free ratio (iFR) and Optical Coherence Tomography (OCT), and they help cardiologist make important decisions […]

OrbusNeich Announces FDA Clearance, Launch of Coronary Dilatation Catheters

HONG KONG, June 6, 2017 /PRNewswire/ — Announcement marks company‘s official entry into the US market OrbusNeich, a global company specializing in the provision of life-changing vascular solutions, has announced the launch of its world-renowned Sapphire PTCA balloon dilatation catheters following their recent 510k clearance by the FDA: the Sapphire™ […]

Edwards SAPIEN 3 Valve Receives FDA Approval For Aortic, Mitral Valve-In-Valve Procedures

IRVINE, Calif., June 5, 2017 — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced it has received U.S. Food and Drug Administration (FDA) approval for aortic and mitral valve-in-valve procedures using the Edwards SAPIEN 3 transcatheter heart valve. […]