First Gynecological Procedures Performed with Medtronic Hugo Robotic-Assisted Surgery System

- Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced the first gynecological (GYN) procedures with the Hugo™ robotic-assisted surgery (RAS) system. The six cases included hysterectomies and myomectomies performed by Salomón Zebede, M.D., and Juan Carlos López, M.D., last week at Pacifica Salud Hospital in Panama City, Panama .

Salomón Zebede, M.D., a urogynecology and reconstructive pelvic surgeon and member of the robotic department at Pacifica Salud Hospital in Panama, gets ready to perform one of the first gynecologic procedures with the Hugo™ robotic-assisted surgery system.

"As the cornerstone of our new robotic surgery program, the Hugo RAS system is playing a critical role in bringing the benefits of minimally invasive surgery to more patients in our region," said Dr. Zebede. "It was energizing to perform the very first GYN procedure with the Hugo system, and encouraging to experience firsthand the possibility this technology brings to women's health."

Globally, more than 60% of hysterectomies are performed as open procedures, 1 even though minimally invasive surgery offers fewer complications, shorter hospital stays, and faster return to normal activities. 2-4

Pacifica Salud is the latest institution to join Medtronic's Partners in Possibility Program, a group of pioneering hospitals that will be among the first in the world to use the Hugo RAS system. Earlier this month, the hospital announced its first five urological cases with the Hugo RAS system. Pacifica Salud is also an early adopter of Touch Surgery™ Enterprise, a cloud-based surgical video capture solution that allows surgeons to seamlessly record, analyze, and share surgical video.

"We are witnessing the dawn of a new era in robotic surgery," said Mr. Rafael Cohen , CEO of Pacifica Salud. "That is made possible by the Hugo system, our partnership with Medtronic, and our talented team at Pacifica Salud."

The Hugo RAS system — Medtronic's solution to historic cost and utilization barriers that have kept surgical robotics out of reach for many hospitals — is a modular, multi-quadrant platform designed for a broad range of soft-tissue procedures. In June, Medtronic announced the first clinical procedures with the Hugo system took place in Santiago, Chile . That marked the beginning of the Hugo RAS system patient registry, which is collecting clinical data to support regulatory submissions around the world.

"As an OB/GYN, I'm incredibly passionate about advancing women's health and wellbeing through less invasive solutions that improve outcomes and enable a better quality of life," said Carla Peron , M.D., chief medical officer of the Surgical Robotics business, which is part of Medical Surgical Portfolio at Medtronic. "The first GYN procedures with the Hugo RAS system represent an exciting step toward expanding access to more treatment options, including the benefits of robotic-assisted surgery, to women everywhere."

Medtronic has a longstanding history of making a positive impact on women's health through technology. The Hugo RAS system joins a portfolio of gynecological products designed to enable less invasive surgical treatment of a range of conditions including abnormal uterine bleeding, uterine fibroids, and endometrial cancer.

"I'm proud of the work we're doing at Medtronic with our healthcare partners around the world to improve women's health," said Megan Rosengarten , president of Surgical Robotics. "Advancing access for women to minimally invasive surgical care is a great responsibility and privilege, which makes today's announcement about the Hugo system all the more meaningful."

The Hugo RAS system is not cleared or approved in the U.S. or Europe . Regulatory requirements of individual countries and regions will determine availability and approval or clearance timelines. Touch Surgery Enterprise is available in the U.S. and Europe ; it is not intended to direct surgery, or aid in diagnosis or treatment of a disease or condition.

For more information, visit medtronic.com/hugo .

About Medtronic
Medtronic plc ( www.medtronic.com ), headquartered in Dublin, Ireland , is among the world's largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

  1. Based on internal estimates and Medtronic report, FY20 market model: procedural volume data.
  2. Fitch K, Engel T, Bochner A. Cost differences between open and minimally invasive surgery. Managed Care. 2015 Sep;24(9):40–8.
  3. Tiwari MM, Reynoso JF, High R, Tsang AW, Oleynikov D. Safety, efficacy, and cost effectiveness of common laparoscopic procedures. Surg Endosc. 2011;25(4):1127-1135.
  4. Roumm AR, Pizzi L, Goldfarb NI, Cohn H. Minimally invasive: minimally reimbursed? An examination of six laparoscopic surgical procedures. Surg Innovation. 2005;12(3):261–287.

Contacts:




Gary Jeanfaivre

Ryan Weispfenning

Public Relations

Investor Relations

+1-203-833-2104

+1-763-505-4626

Touch Surgery™ Enterprise is a cloud-based surgical video capture solution that allows surgeons to seamlessly record, analyze, and share surgical video.

The Hugo™ robotic-assisted surgery system from Medtronic is a modular, multi-quadrant platform for soft-tissue robotic-assisted surgery.

Medtronic plc (PRNewsfoto/Medtronic plc)

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SOURCE Medtronic plc

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(PRNewsfoto/Medtronic plc)

Sphere-360 Study Safety and Performance

Sphere-360 is an investigational, first-of-its-kind, single-shot PFA mapping and ablation catheter for treatment of paroxysmal atrial fibrillation (PAF). Results for Sphere-360 at one year, in a prospective, single-arm, multi-center trial performed in European centers, demonstrated freedom from arrhythmia recurrence in 88% of patients, with chronically durable pulmonary vein isolation (PVI) in 98% of targeted veins and no reported safety events in a sub-group treated with the most optimized waveform. The Sphere-360 catheter has a large, conformable lattice design that can be modified into various shapes, is seamlessly integrated with the Affera Mapping and Ablation System and utilizes an 8.5 Fr sheath – the smallest in any single-shot PFA technology.

"The Affera technology is a sophisticated ecosystem, including an advanced, intuitive mapping system and catheters that are seamlessly integrated to offer treatment options for different cardiac arrhythmias. It is encouraging to see the promising results for Sphere-360, which can easily create circumferential lesions without the need for catheter rotation," said Vivek Reddy , M.D., Director of Cardiac Arrhythmia Services for the Mount Sinai Health System in New York City . "The study results showed Sphere-360 has a promising safety and performance profile with zero serious adverse events observed. Upon approval, Sphere-360 will be a valuable addition to Medtronic's Affera system, which has been a game changer for Afib treatment and physician workflow."

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Sphere-9 for Linear Ablation

Additionally, in a sub-analysis from the Sphere Per-AF IDE study , results demonstrated that the Sphere-9 catheter can be used safely and effectively to create linear lesions in persistent AF patients. Linear ablation is often used in conjunction with PVI to improve the chances of restoring a normal heart rhythm without recurrence in persistent AF patients. The Sphere Per-AF IDE study evaluated the safety, efficacy and efficiency of Affera and Sphere-9 in persistent AF and led to the FDA approval of Affera in October 2024 .

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AFib is one of the most common and undertreated heart rhythm disorders, affecting more than 60 million people worldwide. 1 Afib is a progressive disease, often beginning as paroxysmal AFib (presents intermittently) and progressing to persistent (lasts for more than 7+ days without stopping). As the disease progresses, the risk of serious complications including heart failure, stroke and risk of death increases 2-5 .

For more information on the Affera PFA system and the Sphere-9 catheter, visit Medtronic.com.

About Medtronic

Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway , Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE: MDT), visit www.Medtronic.com and follow Medtronic on LinkedIn .

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

References

  1. Roth GA, Mensah GA, Johnson CO et al. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol 2020;76:2982-3021.
  2. Miyasaka Y, Barnes ME, Bailey KR, et al. Mortality trends in patients diagnosed with first atrial fibrillation: a 21-year community-based study. J Am Coll Cardiol 2007;49:986-92.
  3. Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS). Eur Heart J 2020.
  4. Wolf PA , Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22:983-8.
  5. Lubitz SA, Moser C, Sullivan L, et al. Atrial fibrillation patterns and risks of subsequent stroke, heart failure, or death in the community. J Am Heart Assoc 2013;2:e000126

Dr. Reddy is a paid consultant for Medtronic.

Contacts:
Leslie Williamson
Public Relations
+1-612-227-5099

Ryan Weispfenning
Investor Relations
+1-763-505-4626

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SOURCE Medtronic plc

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