GALWAY, Ireland - Medtronic plc (NYSE:MDT), a global healthcare technology leader, announced today that it has received FDA approval for its Affera Mapping and Ablation System with Sphere-9 Catheter. This system is designed for the treatment of persistent atrial fibrillation (AFib) and cavotricuspid isthmus (CTI) dependent atrial flutter.
The Sphere-9 Catheter is notable for its high-density mapping and dual-energy ablation capabilities, combining pulsed field (PF) and radiofrequency (RF) energy. This dual approach provides physicians with more options during procedures. Medtronic is now the only company with two PFA technologies approved by the FDA, the other being the PulseSelect Pulsed Field Ablation System approved in December 2023.
Dr. Vivek Reddy, Director of Cardiac Arrhythmia Services at Mount Sinai Health System, emphasized the significance of the Affera system, highlighting its safety, efficacy, and efficiency, as well as its short learning curve for experienced physicians.
The Sphere-9 catheter integrates with the Affera Mapping and Ablation System to enhance workflow efficiency and safety outcomes. Its unique design allows for a zero-fluoroscopy, zero-exchange workflow, which simplifies the procedure for physicians.
The FDA's approval was based on positive results from the SPHERE Per-AF study, an FDA Investigational Device Exemption (IDE) trial. The system also received CE Mark in March 2023 and Australian approval in September 2024. Additionally, Medtronic began an early feasibility study in October 2024 to evaluate the Sphere-9 catheter for treating ventricular tachycardia (VT).
Rebecca Seidel, president of the Cardiac Ablation Solutions business at Medtronic, expressed the company's commitment to innovation in addressing patient needs and improving outcomes. The Affera system is part of Medtronic's broader vision to advance cardiovascular care.
AFib affects over 60 million people globally and is associated with increased risks of heart failure, stroke, and mortality. The approval of the Affera system represents a significant advancement in the treatment of this widespread heart condition.
The announcement is based on a press release statement from Medtronic plc.
In other recent news, Medtronic has seen significant developments. The company's shareholders recently voted on key proposals at the 2024 Annual General Meeting, including the election of board directors and executive compensation. All ten director nominees were elected, with the lowest support for Kendall J. Powell, who still received over 906 million votes. The board also ratified the appointment of PricewaterhouseCoopers LLP as the independent auditor for fiscal year 2025 with over 1 billion votes.
In terms of financial performance, Medtronic's second quarter fiscal year 2025 revenue and adjusted earnings per share (EPS) are projected to exceed consensus expectations, according to Baird. RBC Capital Markets upgraded Medtronic's rating from Sector Perform to Outperform, citing improved business fundamentals and management's execution capabilities. However, Goldman Sachs reiterated its Sell rating on Medtronic, citing continuous growth in operating expenses and uncertainties in other operating income and expenses.
Medtronic also initiated a voluntary field action for its MiniMed™ 600 and 700 series insulin pumps due to potential battery issues. TD Cowen maintained a Buy rating for Medtronic, citing anticipated growth in the Cardiac and Spinal Technologies (CST) and Spine sectors, driven by the company's artificial intelligence-powered ecosystem, AiBLE. Truist Securities raised its price target for Medtronic following the company's first-quarter earnings, which surpassed revenue expectations. These are all recent developments in the company's journey.
InvestingPro Insights
Medtronic's recent FDA approval for its Affera Mapping and Ablation System aligns well with its position as a prominent player in the Healthcare Equipment & Supplies industry, as highlighted by InvestingPro Tips. This innovative technology could potentially contribute to the company's future revenue growth, which currently stands at 3.23% for the last twelve months.
The company's strong financial position is evident from InvestingPro Data, showing a market capitalization of $116.79 billion and a revenue of $32.58 billion over the last twelve months. This robust financial foundation supports Medtronic's ongoing investment in cutting-edge technologies like the Affera system.
InvestingPro Tips also reveal that Medtronic has maintained dividend payments for 48 consecutive years and has raised its dividend for 10 consecutive years. This demonstrates the company's commitment to shareholder returns, which could be further bolstered by successful commercialization of new products like the Affera system.
It's worth noting that Medtronic is trading near its 52-week high, with a strong return of 16.29% over the last three months. This positive market sentiment might reflect investor confidence in the company's innovative pipeline and recent regulatory approvals.
For investors seeking more comprehensive analysis, InvestingPro offers 12 additional tips for Medtronic, providing a deeper understanding of the company's financial health and market position.
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