Medical Devices & Technology

SHERIDAN, WYOMING – May 5, 2025 – Johnson & Johnson MedTech has announced encouraging 3-month results from its pivotal Omny-IRE clinical trial, spotlighting the high-performance capabilities of its investigational OMNYPULSE™ Platform. Unveiled during the 2025 Heart Rhythm Society (HRS) Annual Meeting and simultaneously published in JACC Clinical Electrophysiology, the findings mark a strategic milestone in the company’s pulsed field ablation (PFA) portfolio expansion, with significant implications for patient care, procedural efficiency, and technology adoption in electrophysiology.

Breakthrough Results from the Omny-IRE Trial

SHERIDAN, WYOMING – May 5, 2025 – Johnson & Johnson MedTech has announced the presentation of 22 sponsored or funded clinical studies at the Heart Rhythm Society (HRS) 2025 Annual Meeting in San Diego, showcasing its continued leadership in the electrophysiology space. The company’s expansive dataset highlights innovation in pulsed field ablation (PFA) technologies, real-world treatment strategies, and critical insights from the REAL-AF Registry and Patient Care Pathways and Outcomes study—reinforcing its commitment to evidence-based care and better patient outcomes.

Driving Strategic Innovation in Cardiac Electrophysiology

SHERIDAN, WYOMING – May 5, 2025 – Johnson & Johnson MedTech has marked a significant milestone in the evolution of robotic-assisted surgery by completing the first clinical trial cases of its OTTAVA™ Robotic Surgical System. This development positions the company at the forefront of innovation in minimally invasive procedures, reinforcing its strategic commitment to delivering cutting-edge surgical technologies that raise standards in operating rooms worldwide.

Strategic Leap in Robotic-Assisted Surgery

The inaugural clinical cases for the OTTAVA system were led by Dr. Erik Wilson, Chief of Minimally Invasive and Elective General Surgery at UT Health Houston, who performed Roux-en-Y gastric bypass surgeries at Memorial Hermann-Texas Medical Center. These procedures represent the first real-world clinical application of the OTTAVA system and a pivotal moment in its developmental journey.

SHERIDAN, WYOMING – May 5, 2025 – Shockwave Medical, Inc., a Johnson & Johnson MedTech company and global leader in circulatory restoration, has officially initiated its FORWARD CAD Investigational Device Exemption (IDE) study. This pivotal research effort will evaluate the safety and efficacy of the Shockwave Javelin Coronary IVL Catheter for the treatment of difficult-to-cross, heavily calcified coronary artery lesions—an area with high unmet clinical need and procedural risk.

The first patient in the study was successfully treated by Dr. Evan Shlofmitz and Dr. Ziad Ali at St. Francis Hospital & The Heart Center in Roslyn, New York. This milestone underscores the growing clinical interest in Shockwave’s forward IVL (intravascular lithotripsy) platform as a potential alternative to atherectomy, especially in complex percutaneous coronary interventions (PCI).

Advancing Treatment for Challenging Coronary Artery Disease

SHERIDAN, WYOMING – May 5, 2025 – Medtronic plc (NYSE: MDT), a global leader in healthcare technology, has received U.S. Food and Drug Administration (FDA) approval for its Simplera Sync™ sensor, marking a significant expansion of its continuous glucose monitoring (CGM) portfolio in the United States. The approval enables integration of the Simplera Sync™ sensor with the company’s flagship MiniMed™ 780G system, offering greater flexibility and convenience to people managing diabetes through advanced insulin delivery technology.

Strategic Advancement in Diabetes Care Technology

SHERIDAN, WYOMING – May 5, 2025 – Medtronic plc (NYSE: MDT), a global leader in healthcare technology, has officially submitted 510(k) applications to the U.S. Food and Drug Administration (FDA) for its MiniMed™ 780G pump and SmartGuard™ algorithm, paving the way for seamless integration with Abbott’s advanced continuous glucose monitoring (CGM) platform. This critical regulatory milestone strengthens Medtronic’s strategic partnership with Abbott and positions the company to deliver more interoperable, intelligent diabetes care solutions to the U.S. market.

Accelerating Innovation Through Strategic Interoperability

SHERIDAN, WYOMING – May 5, 2025 – Medtronic plc (NYSE: MDT), a global leader in healthcare technology, has received U.S. Food and Drug Administration (FDA) approval for the OmniaSecure™ defibrillation lead—the smallest-diameter, catheter-delivered defibrillation lead for right ventricular implantation. This approval marks a major advancement in cardiac rhythm management, offering physicians a less invasive, highly durable solution to treat life-threatening arrhythmias in both adults and adolescents with smaller anatomies.

Strategic Advancement in Cardiac Rhythm Management

The FDA’s green light for the OmniaSecure lead strengthens Medtronic’s leadership in electrophysiology and expands its robust portfolio of transvenous lead solutions. At only 4.7 French (1.6mm) in diameter, the OmniaSecure lead builds on the proven SelectSecure™ Model 3830 pacing lead platform, already widely adopted in the clinical community for over two decades.

SHERIDAN, WYOMING – May 5, 2025 – Medtronic has announced a major milestone for its Hugo™ robotic-assisted surgery (RAS) system, as the Expand URO U.S. clinical trial met both primary safety and effectiveness endpoints. The results position the company for strategic market entry into the U.S. robotic-assisted surgery sector, the largest of its kind globally, and were presented as a late-breaking session at the American Urologic Association (AUA) annual meeting in Las Vegas.

Landmark Trial Sets New Benchmark in Robotic Urologic Surgery

The Expand URO study is the largest Investigational Device Exemption (IDE) trial conducted in the U.S. for multi-port robotic-assisted urologic procedures. Designed as a prospective, multi-center, single-arm study, it involved 137 patients across six hospitals. Participants underwent one of three common urologic surgeries — prostatectomy, nephrectomy, or cystectomy — using the Hugo RAS system.

SHERIDAN, WYOMING – May 5, 2025 – Medtronic plc (NYSE: MDT) has announced encouraging one-year clinical outcomes for its investigational Affera™ pulsed field ablation (PFA) technologies, reinforcing its strategic leadership in arrhythmia management. The results—revealed at the Heart Rhythm Society 2025 Annual Meeting—highlight the performance of the next-generation Sphere-360™ single-shot PFA catheter and the dual-energy Sphere-9™ catheter in treating patients with paroxysmal and persistent atrial fibrillation (AFib), one of the world’s most prevalent cardiac rhythm disorders.

Sphere-360™ Demonstrates Safety, Efficiency, and Superior Mapping Integration

The Sphere-360 catheter, part of the Affera ecosystem, is engineered as a single-shot PFA mapping and ablation tool designed specifically for paroxysmal AFib. In a European-based, multi-center clinical trial, the technology achieved: