Author: Ken Dropiewski

BIOTRONIK Launches Edora Pacemaker Series with MRI AutoDetect Technology

LAKE OSWEGO, Ore., June 7, 2017 /PRNewswire/ — BIOTRONIK today announced the availability of the Edora line of devices, the company’s first available pacemaker series featuring BIOTRONIK’s MRI AutoDetect technology. Edora SR-T is the smallest MR conditional pacemaker with automated MRI detection capability available in the US with a volume of […]

Europe’s LimFlow Hires a COO and Opens Bay Area Office

LimFlow Expands Senior Management Team And Opens Silicon Valley Office PARIS–(BUSINESS WIRE)–LimFlow SA, developer of minimally-invasive technology for the treatment of end-stage critical limb ischemia (CLI), a severe form of peripheral artery disease (PAD), today announced the expansion of the company’s senior management team. Sophie Humbert, PhD, has been appointed […]

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 […]

SecurAcath Receives NICE Recommendation: Highlights Massive Cost Savings from Improved Catheter Securement

PLYMOUTH, Minn.–(BUSINESS WIRE)–Interrad Medical, a privately held medical device company, announces the SecurAcath Subcutaneous Engineered Stabilization Device is now recommended by the National Institute for Health and Care Excellence (NICE). The SecurAcath underwent a detailed assessment under the Medical Technologies Evaluation Program. As a result, NICE has published guidance supporting […]

Cagent Vascular Completes Enrollment of PRELUDE Study Using Serranator Device

WAYNE, Pa.–(BUSINESS WIRE)–Cagent Vascular, a developer of next generation technology for vessel dilatation in cardiovascular disease interventions, including the FDA 510(k) cleared Serranator® Alto PTA Serration Balloon Catheter, announces the completion of enrollment in the First-in-Human PRELUDE Study. The purpose of this prospective, single-arm, multicenter feasibility study is to show […]

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. […]