Affera, Inc.

Medtronic is continuing to build out its pulsed field ablation offerings. The Dublin-based company said the Affera Sphere-360 catheter won CE mark for the treatment of paroxysmal atrial fibrillation, and the first cases of the device used in the Horizon 360 IDE pivotal trial were completed. Sphere-9 is the only all-in-one, dual energy mapping and ablation catheter for treatment of persistent AFib and concomitant CTI-dependent atrial flutter.  Medtronic said the Affera system, together with the Sphere-9 catheter, enables physician treatment flexibility with its wide area focal design and 9mm lattice tip that can be used with an 8.5Fr sheath. Medtronic inherited the device when it acquired Affera in 2022. The Horizon 360 IDE study is a prospective, single-arm clinical study at centers across the U.S. The study will evaluate the safety and effectiveness of the Sphere-360 catheter with the Affera mapping and ablation system for treating paroxysmal AFib. "The achievement of CE Mark for Sphere-360, as well as the first cases in the U.S. IDE trial, mark two major achievements in our effort to deliver new and better treatments to AFib patients," said Rebecca Seidel, president of the Cardiac Ablation Solutions business, which is part of the Cardiovascular Portfolio. "We're committed to leading in PFA and bringing meaningful innovation at a regular cadence." Medtronic first won approval for PFA technology to treat AFib in 2023. In a November earnings call, Geoff Martha, chairman and CEO of Medtronic, discussed the impact of the company’s PFA offerings. According to a Seeking Alpha transcript of the earnings call, Martha said. “In Cardiac Ablation, our PFA franchise is generating just a ton of momentum. We grew 71%, which is a strong acceleration from last quarter's nearly 50% CAS growth. This is the highest growth rate of any company in this large and fast-growing space. We're winning share as our PFA franchise grew over 300% in the U.S., as well as in international markets. This was based on the strength of our Affera mapping system and our Sphere-9 dual energy and high-density mapping catheter.” “Look, physicians tell us that they appreciate not only the shorter procedure times that they're seeing with Affera, but increasingly, they're calling out its outstanding durability as well,” he said according to the Seeking Alpha transcript. “And demand continues to be extremely high as we hear repeatedly from customers that they want to purchase additional Affera systems to expand into even more of their labs. And in the vast majority of instances, when a new Affera system goes into a lab, we take the majority of the AFib procedure share in that lab.”

An earnings beat isn’t the biggest story coming out of Medtronic this week. While that bodes well for the medtech giant, the biggest news is that Elliot Investment Management has acquired a stake in the company. And that means that big changes are coming as a result of the partnership. During an earnings call, the Dublin-based company said it was expanding the size of its board and looking at more M&A – two initiatives tied to the partnership with Elliot Investment. Medtronic said its board has formed the following special committees. The Operating Committee will align governance, including actions company management is taking to improve efficiency in its global manufacturing, supply chain, and operations. The Growth Committee will be responsible for guiding the evaluation and execution of growth-accretive tuck-in M&A, organic R&D investments, and potential divestitures, including the continued execution of the recently announced plan to separate its Diabetes business. According to a Seeking Alpha transcript of the earnings call, Medtronic’s CEO and Chairman, Geoff Martha, spoke about some of the decisions that Elliot said could help drive value creation. “One is more M&A, okay,” Martha said, according to a Seeking Alpha transcript of the earnings call. “The Affera deal is looking great. And like I said, we feel like the team has the bandwidth to integrate more such deals like that, not necessarily in AFib, but across the company in these high-growth areas. So, more M&A.” Medtronic revenue and EPS for FQ26 beat consensus. Medtronic’s fiscal year ends on the last Friday in April of each calendar year. The company maintained revenue guidance for its fiscal year and raised EPS guidance due in part to a lower tariff impact. However, Needham analysts noted that organic growth slowed modestly to 4.8% in F1Q26 from 5.4% in F4Q25, as Cardiovascular, Medical Surgical, and Diabetes all beat consensus. In a research note, Needham Analyst, Mike Matson wrote, “We believe that Medtronic is in the early stages of a strong product cycle and expect Elliott's involvement to help create shareholder value, but we maintain our Hold rating until there are signs that its organic growth is seeing meaningful, and sustainable, acceleration beyond 5%.” “The most incremental update was the appointment of two new board members and creation of two new value-creation committees in connection with Elliott Management’s new stake in the company,” Brandon Vazquez, an analyst with William Blair, wrote in a research note.  “Details on changes are light (expect more in the middle of calendar 2026), and while this could help unlock long-term value, we suspect it could limit valuation expansion until investors get more details.”

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