Tag: Medtronic

Medtronic Announces FDA Approval and U.S. Launch of Next Generation Pacemakers

DUBLIN – November 20, 2017 – Medtronic (NYSE: MDT) today announced U.S. Food and Drug Administration (FDA) approval and U.S. commercial launch for its portfolio of Azure(TM) pacemakers with BlueSync(TM)technology. Available in both single chamber and dual chamber models, the Azure XT MRI and Azure S MRI pacemakers offer improved longevity, estimated at 13.7 […]

Medtronic gains new CPT codes for Venous device in 2018

Medtronic’s VenaSeal Closure System Receives New CPT Codes By Endovascular Today November 13, 2017—Medtronic has advised that their VenaSeal closure system received a favorable new CPT code as a Level 4 vascular procedure as part of the calendar year 2018 Medicare Physician Fee Schedule and Hospital Outpatient Prospective Payment and Ambulatory Surgical Center […]

Medtronic Evolut(TM) PRO TAVR System with Advanced Sealing Maintains Excellent Outcomes Over Time

DUBLIN and DENVER – November 2, 2017 – Medtronic plc (NYSE:MDT) today presented new data at the Transcatheter Cardiovascular Therapeutics (TCT) Annual Meeting showcasing the excellent clinical performance of the Evolut(TM) Transcatheter Aortic Valve Replacement (TAVR) platform. Six-month data from the newest-generation Evolut PRO System demonstrated continued benefits of its unique valve […]

Medtronic Shows Off Early Intrepid TMVR Data

DUBLIN and DENVER – November 1, 2017 – Medtronic (NYSE:MDT) today presented positive data for its self-expanding Intrepid(TM) transcatheter mitral valve replacement (TMVR) system in patients with severe, symptomatic mitral valve regurgitation. Presented as a First Report Investigation at the Transcatheter Cardiovascular Therapeutics (TCT) Annual Meeting and simultaneously published in the Journal of the American […]

Surmodics Announces First Patient Enrolled in TRANSCEND Pivotal Clinical Trial for SurVeil® Drug-Coated Balloon

EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies, today announced enrollment of the first patient in TRANSCEND, the pivotal clinical trial for the SurVeil® drug-coated balloon (DCB). The randomized trial will evaluate the SurVeil DCB for treatment for peripheral artery disease (PAD) in […]

First Patient Treated in Medtronic’s Landmark Transcatheter Mitral Valve Replacement (TMVR) Pivotal Trial

DUBLIN – October 23, 2017 – Medtronic (NYSE:MDT) today announced the first patient implant in the APOLLO Trial – the pivotal trial designed to evaluate the Intrepid(TM) TMVR system following receipt of an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA). As the first-ever pivotal trial for transcatheter […]

Medtronic (MDT)’s Stent System Wins FDA OK to Treat Short Neck Anatomies When Used With Heli-FX EndoAnchor System

DUBLIN – October 9, 2017 – Medtronic plc (NYSE: MDT) today announced that it has received U.S. Food and Drug Administration (FDA) approval for the Endurant(TM) II/IIs stent graft system to treat abdominal aortic aneurysm (AAA) patients with neck lengths down to 4mm and <=60° infra-renal angulation when used in combination […]

Medtronic HeartWare(TM) HVAD(TM) System Approved for Destination Therapy

DUBLIN – September 27, 2017 – Medtronic plc (NYSE: MDT) has received U.S. Food and Drug Administration (FDA) approval for its HeartWare(TM) HVAD(TM) System as a destination therapy for patients with advanced heart failure who are not candidates for heart transplants. The HVAD System, a left ventricular assist device or LVAD, […]

Medtronic (MDT) Announces Clinical Study To Evaluate The Corevalve Evolut PRO System In ‘Everyday’ Clinical Practice

DUBLIN – September 21, 2017 – Medtronic plc (NYSE: MDT) today announced a new post-market clinical study to evaluate its CoreValve(TM) Evolut(TM) PRO valve in everyday clinical practice. Studying patients with severe symptomatic aortic stenosis at an intermediate, high or extreme risk for open heart surgery, the FORWARD PRO Clinical Study […]