Medtronic Plc NYSE:MDT Price, Chart, News & Insight

# Medtronic Expands European Approval for Affera System to Treat Ventricular Arrhythmias

Medtronic (NYSE: MDT) announced an expanded CE Mark indication for its Affera Mapping and Ablation System with the Sphere-9 Catheter, allowing the technology to be used in Europe to treat ventricular arrhythmias, including ventricular tachycardia and premature ventricular complexes.

The expanded indication opens another potential growth market for Medtronic's cardiac ablation business as the company continues the global rollout of its Sphere-9 technology.

## Sphere-9 Gains First-of-Its-Kind CE Mark

According to Medtronic, Sphere-9 is the first all-in-one mapping and ablation, large-tip focal, dual-energy catheter to receive CE Mark authorization for ventricular ablation.

The system combines high-definition cardiac mapping with both pulsed field and radiofrequency ablation in a single catheter. This allows physicians to map abnormal electrical activity and select between the two energy sources during cardiac ablation procedures.

Medtronic said the technology could address an important unmet need in ventricular arrhythmias, where treatment options include medications, implanted defibrillators and catheter ablation.

## U.S. Clinical Trial Underway

Medtronic is also working toward expanding Sphere-9's ventricular indication in the United States.

The FDA has granted the catheter Breakthrough Device Designation for treating ventricular arrhythmias, providing an expedited regulatory pathway for the technology.

Enrollment is now underway in the Sphere VT pivotal trial, which will evaluate Sphere-9 for ventricular tachycardia and is intended to support a potential future U.S. approval.

The expanded European indication adds to Medtronic's broader push into next-generation electrophysiology. For the company, extending Sphere-9 beyond its existing applications could expand the addressable market for the Affera platform while strengthening its position in the growing cardiac ablation market.

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Global Finance News 08-07-26

Medtronic (MDT) rose about 5% after delivering a strong earnings report that exceeded expectations, posted its fastest annual revenue growth in a decade, and issued better-than-expected fiscal 2027 guidance.

The medical device giant reported fourth-quarter revenue of $9.8 billion, up 9.9% year-over-year, while non-GAAP EPS came in at $1.55, ahead of management's guidance. The company benefited from broad-based strength across its portfolio, particularly in cardiovascular devices, diabetes care, and surgical products. One standout was Cardiac Ablation Solutions, where revenue surged 78% globally and 124% in the United States as Medtronic continued gaining market share.

Investors were particularly encouraged by the company's outlook. Medtronic expects fiscal 2027 organic revenue growth of 6.75% to 7.25% and non-GAAP EPS of $5.90 to $6.00, implying earnings growth of roughly 7% to 9%. The guidance suggests management expects its growth momentum to continue despite tariffs and other macroeconomic headwinds.

The company also highlighted several growth drivers, including its Affera cardiac ablation platform, Hugo robotic surgery system, Symplicity renal denervation technology, and Stealth AXiS surgical navigation platform. Recent acquisitions and investments in areas such as coronary intervention, neurovascular devices, neuromodulation, and cardiovascular technologies further reinforced confidence in future growth prospects.

Another positive factor for income-focused investors was Medtronic's announcement of its 49th consecutive annual dividend increase, raising the annual dividend to $2.88 per share. The company generated $7.3 billion of operating cash flow during fiscal 2026 and ended the year with $9.2 billion in cash and investments, highlighting its strong financial position.

Overall, investors appear to be rewarding Medtronic for delivering accelerating revenue growth, strong execution in key product categories, a healthy pipeline of new technologies, and an upbeat outlook for fiscal 2027. The combination of earnings upside, guidance growth, market-share gains, and dividend increases explains the stock's strong move higher following the results.

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Global Finance News 06-03-26

Medtronic plc announced it has received CE Mark approval for its Stealth AXiS surgical system, a next-generation platform integrating planning, navigation, and robotics into a single solution.

The system is designed for spine and cranial procedures and features AI-driven capabilities, including real-time anatomical tracking and advanced visualization tools to support more precise and personalized surgeries. The platform also connects pre-, intra-, and post-operative workflows within Medtronic’s broader digital ecosystem.

The approval follows recent U.S. FDA clearances, enabling the company to expand access to the technology across Europe.

Source: Medtronic press release, PRNewswire

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The Investor 04-28-26

Medtronic reported positive clinical progress for its Affera™ cardiac ablation technologies, highlighting new data and regulatory milestones at the Heart Rhythm Society 2026 meeting. Interim results showed that 65.5% of patients treated with the Sphere-9™ catheter remained free from ventricular tachycardia recurrence after six months.

The Sphere-9 catheter also received FDA Breakthrough Device Designation for treating ventricular tachycardia, while a U.S. pivotal trial has been approved. Additional data for the Sphere-360™ catheter demonstrated high durability in atrial fibrillation procedures, with consistent outcomes across different patient anatomies.

Medtronic also announced the launch of a new global study to evaluate the technology in a broader group of atrial fibrillation patients, supporting continued expansion and clinical validation of its cardiac rhythm treatment portfolio.
PRNewswire

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The Investor 04-26-26

Medtronic announced it has completed the acquisition of CathWorks for $585 million, with additional potential earn-out payments, strengthening its position in cardiovascular diagnostics.

The deal brings CathWorks’ FFRangio® System into Medtronic’s portfolio—a non-invasive, AI-driven technology that enables comprehensive assessment of coronary artery disease using standard angiograms, without the need for pressure wires or drug-induced stress. This represents a shift from traditional invasive methods toward faster and more efficient diagnostics.

Clinical data from a large global trial showed the system delivers comparable outcomes to conventional techniques while improving procedure efficiency and reducing resource use. Medtronic expects the acquisition to expand global access to the technology and enhance physician decision-making with data-driven insights.

The transaction aligns with Medtronic’s strategy to invest in high-growth innovations and accelerate digital transformation in cardiovascular care.
PRNewswire

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Global Finance News 04-20-26

Medtronic plc (NYSE: MDT) will report financial results on Wednesday, June 3, 2026

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European Investor 04-13-26

GE HealthCare and Medtronic Integrate Surgical Imaging and Navigation Systems

GE HealthCare announced a digital integration between its bkActiv intraoperative ultrasound system and Medtronic’s Stealth AXiS surgical navigation platform.

The integration enables neurosurgeons to access real-time imaging during cranial procedures, combining ultrasound visualization with surgical navigation and robotics in a unified workflow. The system is designed to improve precision and decision-making by allowing surgeons to monitor anatomical changes, such as brain shift, during operations.

The Stealth AXiS system recently received FDA clearance for cranial procedures in the U.S., and the combined solution will be showcased at an upcoming neurosurgery conference in May 2026.

The collaboration builds on an existing partnership between the two companies, aimed at advancing next-generation surgical technologies and improving clinical outcomes.
Business Wire

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WS Investor 04-09-26

Medtronic announced that it has received U.S. FDA clearance for its Stealth AXiS surgical system for cranial and ENT procedures.

The system integrates surgical planning, navigation, robotics, and AI into a single platform, enabling greater precision and real-time insights during complex operations. It had previously been cleared for spine procedures earlier in 2026.

Key features include AI-powered brain mapping for cranial surgery and advanced navigation and visualization tools for ENT procedures, as well as real-time imaging integration to support intraoperative decision-making.

Medtronic said the platform is part of its broader strategy to deliver connected, AI-enabled surgical technologies that improve workflow efficiency and patient outcomes across multiple specialties.
PRNewswire

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European Investor 03-28-26

Medtronic partners with Merit Medical to expand chronic back pain treatment options

March 24, 2026 — Medtronic has entered into a distribution agreement with Merit Medical Systems to offer the FDA-cleared ViaVerte™ system, a minimally invasive treatment for chronic vertebrogenic lower back pain.

The ViaVerte system uses basivertebral nerve ablation technology and features a steerable mechanism that allows physicians to precisely target affected nerves. The treatment is designed as a same-day outpatient procedure without implants.

The agreement strengthens Medtronic’s pain management portfolio, which already includes spinal cord stimulation and other intervention therapies, while addressing growing demand for chronic pain treatments.

The companies said the collaboration expands patient access to innovative therapies and reinforces their ongoing partnership in advancing minimally invasive medical solutions.

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WS Investor 03-25-26

Medtronic announced FDA approval for its OmniaSecure™ defibrillation lead for use in conduction system pacing, marking the first device of its kind approved for placement in the left bundle branch area.

The lead enables more physiologic heart pacing by directly engaging the heart’s natural electrical system, while also delivering life-saving defibrillation therapy for patients with serious arrhythmias.

Clinical data showed strong performance, including 100% defibrillation success at implant and low complication rates, supporting its use as an advanced treatment option for patients requiring both pacing and defibrillation.
PRNewsaire

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WS Investor 03-23-26

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