Medtronic (NYSE:MDT) today said it received FDA approval for its Affera mapping and ablation system with the Sphere-9 catheter. The all-in-one, high-density (HD) mapping, pulsed field ablation (PFA) and radiofrequency (RF) ablation system treats persistent atrial fibrillation (AFib) and offers RF ablation for cavotricuspid isthmus (CTI) dependent atrial flutter. Medtronic also recently received the FDA’s […]
Affera
Medtronic wins CE mark for Affera ablation system
Medtronic (NYSE:MDT) announced today that it received CE mark approval for its Affera mapping and ablation system. The Affera system includes the Sphere-9 catheter and Affera Prism-1 mapping software. Together, the system integrates Sphere-9 pulsed-field ablation (PFA), radiofrequency (RF) and high-density (HD) mapping. It maps and ablates atrial arrhythmias — including AFib — and provides […]
Medtronic offered early retirements as medtech industry layoffs mount
Employees in supply chain, cybersecurity and other specific roles were excluded from the offer.
Medtronic (NYSE:MDT) offered early retirement incentives in recent weeks as the world’s largest medical device company seeks to cut costs before the end of its fiscal year in April. The medical device developer and manufacturer has said little about potential job cuts among its ranks, which it reported as more than 95,000 people worldwide at […]
The top 10 cardiac device stories of 2022
From pulsed-field ablation to noninvasive monitoring, this was an exciting year for cardiac device tech. Here are the top 10 cardiac device stories from MassDevice and its sister sites: 10. Medtronic to pay Acutus $17M following EU MDR submission of left-heart access portfolio Earlier this year, Acutus agreed to sell its left-heart access portfolio to […]
Medtronic completes enrollment in pulsed-field ablation catheter trial
Medtronic today announced it completed enrollment and final treatment in the Sphere Per-AF pivotal trial to study Affera’s pulsed-field ablation catheter tech. The trial is evaluating the safety and effectiveness of the Sphere-9. The Sphere-9 is a pulsed field (PF) and radio frequency (RF) ablation and high-density mapping catheter. Along with the Affera cardiac mapping and […]
Medtronic completes Affera acquisition
Medtronic (NYSE:MDT) announced today that it completed its $1 billion acquisition of cardiac mapping and ablation technology developer Affera. Newton, Massachusetts-based Affera designs and manufactures cardiac mapping and navigation systems, as well as catheter-based cardiac ablation technologies, including a differentiated, focal pulsed-field ablation platform for treating cardiac arrhythmias like AFib. In January, Medtronic announced an agreement to […]
What is the future of cardiac ablation?
Pulsed-field ablation (PFA) — a non-thermal method for cardiac ablation — has the potential to positively disrupt the atrial fibrillation market. Amid the excitement around the technology, Medtronic announced in January that it would acquire cardiac mapping and ablation technology developer Affera for nearly $1 billion. Meanwhile, Boston Scientific in February closed its $1.75 billion […]
Medtronic to acquire cardiac arrhythmia treatment developer Affera
Medtronic (NYSE:MDT) announced today that it agreed to acquire cardiac mapping and ablation technology developer Affera. Medtronic CEO Geoff Martha described the deal as a nearly $1 billion transaction at the J.P. Morgan Healthcare Conference today, though he added it includes a $250 million contingent consideration. The company expects the transaction to close in the […]
