Tag: Affera

Medtronic receives CE Mark approval for Affera™ Mapping and Ablation System to treat atrial arrhythmias

First of its kind, all-in-one Sphere-9™ Catheter with pulsed field ablation, radiofrequency, and high density mapping integrated with intuitive mapping and navigation platform DUBLIN, March 15, 2023 /PRNewswire/ — Medtronic (NYSE:MDT) announced today that it has received CE (Conformité Européenne) Mark for the Affera™ Mapping and Ablation System, which includes the Sphere-9™ Catheter and the Affera™ Prism-1 Mapping […]

Medtronic completes enrollment in pivotal trial evaluating first-of-its-kind pulsed field ablation catheter for patients with atrial fibrillation

SPHERE Per-AF will determine the safety and effectiveness of the Sphere-9 cardiac ablation and mapping catheter with the Affera mapping and navigation system DUBLIN, Dec. 5, 2022 /PRNewswire/ — Medtronic (NYSE:MDT) today announced the completion of enrollment and final treatment in the SPHERE Per-AF Trial, a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) pivotal […]

Medtronic completes acquisition of Affera

Acquisition adds mapping and navigation platform to company’s cardiac ablation portfolio and brings an integrated system of diagnostic and therapeutic tools to address a broad spectrum of arrhythmias DUBLIN, Aug. 30, 2022 /PRNewswire/ — Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced that it has completed the acquisition of Affera, Inc. This acquisition expands […]

Medtronic to Acquire Affera

Acquisition to expand company’s cardiac ablation portfolio, including first-time entry into mapping and navigation, within one of the fastest growing medtech markets DUBLIN, Jan. 10, 2022 /PRNewswire(opens new window)/ — Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced that it has entered into a definitive agreement to acquire Affera, Inc., a Boston area-based, privately held medical technology […]

Affera Announces First Patient Treated in SPHERE Per-AF IDE Trial

First enrollment comes as investors provide $75M toward an oversubscribed Series C financing NEWTON, Mass., Dec. 20, 2021 /PRNewswire/ — Affera Inc., a private medical device company focused on innovative cardiac arrhythmia treatment solutions, announced today that the first patient was treated in the recently approved SPHERE PerAF Trial, a U.S. Food and Drug Administration (FDA) Investigational Device […]

Affera Announces World’s First Successful Focal Pulsed Field Ablation in Patients

WATERTOWN, Mass., Dec. 19, 2019 /PRNewswire/ — Affera, Inc., a private medical device company focused on innovative cardiac arrhythmia treatment solutions, announced today that its focal Pulsed Field (“PF”) ablation technology, also known as Irreversible Electroporation (“IRE”), has been successfully used to treat 40 patients suffering from Atrial Fibrillation (“AFIB”).  This multi-center first-in-human study is designed to […]

Affera’s Novel Technology For Cardiac Arrhythmia Treatment To Be Featured In 8 Scientific Sessions At The 2018 Heart Rhythm Society Meeting

WATERTOWN, Mass., May 7, 2018 /PRNewswire/ — Affera, Inc, a private medical device company focused on innovative cardiac arrhythmia treatment solutions, announced today its integrated platform will be highlighted in eight scientific sessions at the Heart Rhythm Society 2018 (HRS) meeting in Boston, Massachusetts. Affera’s revolutionary lesion formation technology offers a solution designed to optimize procedural efficiency and efficacy across a broad […]