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Medtronic's Affera System Receives FDA Approval for Atrial Fibrillation Treatment

• Medtronic's Affera Mapping and Ablation System, integrating mapping, RF, and PFA technologies, has gained FDA approval for treating persistent atrial fibrillation. • The Affera system is the first focal PFA system approved in the U.S., potentially driving significant revenue growth for Medtronic's electrophysiology (EP) business. • Analysts project Medtronic's EP revenue could reach $2.8 billion by 2026 with successful Affera system launch, surpassing current market estimates. • The Affera system's comprehensive features are expected to command a premium price, contributing to Medtronic's earnings per share (EPS) growth.

Medtronic has secured FDA approval for its Affera Mapping and Ablation System, a significant advancement in the treatment of persistent atrial fibrillation. The system integrates mapping, radiofrequency (RF), and pulsed field ablation (PFA) technologies. This approval positions Medtronic as the first company to introduce a focal PFA system in the United States.
The Affera system's comprehensive design is expected to command a premium price, potentially driving substantial revenue growth for Medtronic's electrophysiology (EP) business. Bank of America Securities analyst Travis Steed projects that Medtronic's EP revenue could reach $2.8 billion by 2026 with a successful launch. This figure surpasses current market estimates.
According to Steed, the Affera system's approval, combined with Medtronic's EPS growth, supports a positive outlook for the company. Morgan Stanley also maintained a Buy rating on Medtronic's stock, setting a price target of $98.00.
Medtronic's Affera system represents a significant innovation in the treatment of atrial fibrillation, a condition affecting millions worldwide. The system's integration of multiple technologies into a single platform offers the potential for more efficient and effective ablation procedures.
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Reference News

[1]
Medtronic's Innovative Affera System Gains FDA Approval, Boosting EP Market Prospects
markets.businessinsider.com · Oct 25, 2024

Travis Steed from Bank of America Securities maintains a Buy rating on Medtronic (MDT) with a $100.00 price target, citi...

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