First Procedure in Asia-Pacific Performed with Medtronic Hugo Robotic-Assisted Surgery System

The Robotic Prostatectomy Took Place at Apollo Hospitals, Greams Road, Chennai, India

- Medtronic plc (NYSE:MDT) and Apollo Hospitals Group today announced the first clinical procedure in Asia-Pacific with the Hugo™ robotic-assisted surgery (RAS) system. The robotic prostatectomy was performed on September 17 by Dr. N Ragavan, consultant urologist, uro-oncologist and robotic surgeon, at Apollo Hospitals, Greams Road, Chennai, India .

"Here in India , nearly 70% of surgeries are performed as open procedures 1 — we feel confident that the Hugo RAS system will enable us to change that statistic and bring the benefits of minimally invasive surgery to more patients than ever before," said Dr. Ragavan. "I am incredibly proud to launch this new era of possibility for our hospital and the patients we serve with the very first clinical procedure in the region with the Hugo RAS system."

As a form of minimally invasive surgery, robotic-assisted surgery offers the potential for fewer complications, shorter hospital stays, faster return to normal activities, and smaller scars. 2–4,†

"Today we're taking another exciting step forward to bring the benefits of minimally invasive surgery to more people in more places," said Megan Rosengarten , president of the Surgical Robotics business, which is part of the Medical Surgical Portfolio at Medtronic. "That's possible thanks to a shared vision with Apollo Hospitals, the many surgeons and hospital leaders who have partnered with us on this journey, and our dedicated Surgical Robotics team in India and around the globe."

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. It combines wristed instruments, 3D visualization, and Touch Surgery™ Enterprise, a cloud-based surgical video capture and management solution, with dedicated support teams specializing in robotics program optimization, service, and training. Earlier this year, Medtronic announced that the first urologic and gynecologic procedures with the Hugo RAS system took place in Latin America . Those procedures marked the beginning of the Hugo RAS system patient registry, which is collecting clinical data from those systems as well as the system placed in India to support regulatory submissions around the world.

"With the availability of the Hugo RAS system in India , we know the future of surgery is here," said Madan Krishnan , vice president and managing director, India Medtronic Pvt Ltd. "Medtronic is creating robotic-assisted surgery solutions that are optimized for what clinicians need today and that can be upgraded as the technology evolves and usage expands in the years to come. We're grateful for the opportunity to partner with Apollo Hospitals on this exciting milestone and are looking forward to collaborating in advancing access to the latest therapies for patients."

"As the region's leading healthcare provider, we are dedicated to bringing the very latest in medical technology to our patients," said Dr. Prathap C. Reddy , founder and chairman, Apollo Hospitals Group. "The addition of the Hugo RAS system to our robotic surgery program — and our place in history as the first hospital in Asia-Pacific to use this new technology — reinforces that dedication and the pride we at Apollo Hospitals have as a premier destination for minimally invasive surgery. This technology will complement the excellent clinical expertise garnered by our physicians over the years and is designed to help us enhance patient care."

"We're committed to providing the most advanced and innovative care possible for our patients and are proud to partner with a company that shares our values and vision," said Ms. Preetha Reddy , executive vice chairperson, Apollo Hospitals Group. "There is an urgent need to improve treatment options for surgeries by leveraging technology. Today, robotic technology has come a long way, helping perform some of the most complicated surgeries with precision, and Apollo has always been on the forefront in bringing the most advanced technology to India ."

The Medtronic Hugo RAS system is commercially available in certain geographies. Regulatory requirements of individual countries and regions will determine approval, clearance, or market availability. The Hugo RAS system is pending CE mark for the EU. In the US, the Hugo RAS system is an investigational device not for sale. Touch Surgery Enterprise 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 Apollo Hospitals
Apollo Hospitals was established in 1983 by Dr. Prathap C Reddy, renowned as the architect of modern healthcare in India . As the nation's first corporate hospital, Apollo Hospitals is acclaimed for pioneering the private healthcare revolution in the country. Apollo Hospitals has emerged as Asia's foremost integrated healthcare services provider and has a robust presence across the healthcare ecosystem, including Hospitals, Pharmacies, Primary Care & Diagnostic Clinics and several retail health models. Since its inception, Apollo Hospitals has been honoured by the trust of over 150 million individuals who came from 140 countries. At the core of Apollo's patient-centric culture is TLC (Tender Loving Care), the magic that inspires hope amongst its patients. For further details, log onto: www.apollohospitals.com .

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.

†Compared to open surgery.
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

Medtronic plc

Medtronic plc

+1-203-833-2104

+1-763-505-4626



Masooma Pathre

Saurabh Bose

Public Relations

Brand and Marcomm

Medtronic India

Apollo Hospitals

+91 9819744665

+91 7275798384

Medtronic plc (PRNewsfoto/Medtronic plc)

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Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that it will report financial results for its fourth quarter and full fiscal year 2025 on Wednesday, May 21, 2025 . A news release will be issued at approximately 5:45 a.m. Central Daylight Time (CDT) and will be available at https:news.medtronic.com . The news release will include summary financial information for the company's fourth quarter and full fiscal year 2025, which ended on Friday, April 25, 2025 .

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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."

Medtronic intends to begin its U.S. pivotal trial for the Sphere-360 catheter later this calendar year. Worldwide, Sphere-360 is currently investigational and not approved for sale or distribution.

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 .

"True to our Medtronic mission for patients and legacy of innovation, we are delivering our best-in-class technologies to physicians and improving care for AFib patients, and we are not slowing down," said Rebecca Seidel , president of the Cardiac Ablation Solutions business at Medtronic, which is part of the Cardiovascular portfolio. "These results signify another step forward and energize us as we continue to earn and build our leadership position in electrophysiology every day."

Medtronic is the only company with two PFA offerings for physicians and patients. The PulseSelect™ Pulsed Field Ablation System offers physicians a safe, single-shot solution for pulmonary vein isolation (PVI) and is now available in more than 30 countries. 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 used with an 8.5Fr sheath. Affera is available in Europe , Australia and New Zealand , with global expansion ongoing.

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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(PRNewsfoto/Medtronic plc)

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About the Diabetes Business at Medtronic ( www.medtronicdiabetes.com )
Medtronic Diabetes is on a mission to alleviate the burden of diabetes by empowering individuals to live life on their terms, with the most advanced diabetes technology and always-on support when and how they need it. We've pioneered first-of-its-kind innovations for over 40 years and are committed to designing the future of diabetes management through next-generation sensors (CGM), intelligent dosing systems, and the power of data science and AI while always putting the customer experience at the forefront.

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, including, but not limited to, statements regarding the partnership between Medtronic and Abbott, strategic and other potential benefits of the partnership, Abbott's products and product candidates, and other statements about Medtronic managements' future expectations, beliefs, goals, plans or prospects, are subject to risks and uncertainties including, but not limited to, the ability to obtain regulatory approvals, and other risks and uncertainties such as those described in Medtronic's reports and other filings with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. Medtronic cautions investors not to place considerable reliance on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this document, and Medtronic undertakes no obligation to update or revise any of these statements except to the extent required by law.

Contacts:
Janet Cho
Public Relations
+1-818-403-7028

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

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