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Calgary, Alberta May 24, 2024 - TheNewswire . Ocumetics Technology Corp. (" Ocumetics " or the " Corporation ") ( TSXV: OTC) (OTCQB: OTCFF) (FRA: 2QBO) announces that it has completed the first tranche of the private placement of debentures previously announced by the Corporation on May 15, 2024.
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Calgary, Alberta TheNewswire - February 29, 2024 - Ocumetics Technology Corp. ("Ocumetics") (TSXV:OTC) (OTC:OTCFF) (FRA:2QBO), is pleased to invite investors and other interested parties to attend an upcoming interview with Market Radius Research.
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Calgary, Alberta TheNewswire - December 21, 2023 - Ocumetics Technology Corp. (" Ocumetics " or the " Corporation ") (TSXV:OTC) (OTC:OTCFF) (FRA:2QBO) is pleased to announce that the TSX Venture Exchange has granted a 15-day extension to close the Corporation's non-brokered private placement announced on November 15, 2023. The new closing deadline for the private placement is January 15, 2024.
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Ocumetics Technology Corp. (" Ocumetics ") ( TSXV:OTC) (OTC:OTCFF) (FRA:2QBO) a pioneer in the field of ophthalmic innovation, announces a webinar to discuss the successful completion of its biocompatibility animal study and its upcoming first-in-human study, anticipated to commence in Q1 2024 in the Dominican Republic
Dean Burns, CEO of Ocumetics and 27-year Alcon veteran, will lead the presentation.
Click Image To View Full Size
Join the webinar to:
Learn more about the significance of the biocompatibility animal study;
Learn more about the upcoming first-in-human study; and
Ask questions regarding the Ocumetics Accommodating Lens and the company's plans.
Details are as follows:
Date: December 20, 2023
Time: 18:00 EST
RSVP: https://ocumetics.com/webinar-december-20-2023/
About Ocumetics
Ocumetics Technology Corp. ( TSXV: OTC) (OTCQB: OTCFF) (FRA: 2QBO), headquartered in Calgary, Alberta, Canada, is an innovator in the field of ophthalmic technology, dedicated to developing and commercializing advanced vision correction solutions that enhance the quality of life for individuals worldwide.
Ocumetics is in the preclinical study stage of a game-changing technology for the ophthalmic industry. In its pursuit of a next generation interocular lens solution, Ocumetics has developed the Ocumetics Accommodating Lens, an expandable intraocular lens that fits within the natural lens compartment of the eye potentially to eliminate the need for corrective lenses. It is designed to allow the eye's natural muscle activity to seamlessly shift focus from distance to intermediate to near.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Dean Burns
President and CEO
(817) 874-7564
Dayton Marks
Director
(778) 347-2500
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Copyright (c) 2023 TheNewswire - All rights reserved.
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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 .
Medtronic will host a video webcast at 7:00 a.m. CDT on May 21, 2025 , to discuss results for its fourth quarter and full fiscal year 2025. The webcast can be accessed at https://investorrelations.medtronic.com .
Within 24 hours of the broadcast, a replay and transcript of the prepared remarks will be available by clicking on the Events link at https://investorrelations.medtronic.com .
Looking ahead to fiscal year 2026, Medtronic plans to report its first, second, third, and fourth quarter results on Tuesday, August 19, 2025 , November 18, 2025 , February 17, 2026 , and Wednesday, May 20, 2026 , respectively. For these events, confirmation and additional details will be provided closer to the specific event.
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.
Contacts:
Erika Winkels
Public Relations
+1-763-526-8478
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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SOURCE Medtronic plc
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Star Jones , award winning television personality & women's heart health advocate, helps kick off heart health conversations this Mother's Day with the Medtronic 'Letter to My Mother' campaign
A new Medtronic-sponsored survey of women ages 30-50 reveals a significant gap in awareness and discussion around heart health among women and their mother-figures. Despite cardiovascular disease being the #1 killer of women in the U.S. many women are still unaware of the risk and the importance of heart health.
The survey, endorsed by WomenHeart and conducted by Wakefield Research, found that nearly half of women (45%) were more likely to discuss sensitive topics such as politics, money, or relationships with their mother or grandmother before discussing family heart health history, despite the fact that as much as half of the risk for heart disease is hereditary.
For more than a century, heart disease has remained the leading cause of death in women, accounting for more deaths than all cancers combined. Yet, when it comes to serious heart concerns, women are up to 35% less likely to be treated with proven, minimally invasive solutions for heart valve failure than men, and women account for more than half (52%) of deaths caused by high blood pressure. 1 Additionally, women often experience heart attack symptoms differently, and heart disease disproportionately impacts women of color, with 43% of Hispanic women and 59% of Black women experiencing some form of cardiovascular disease.
The Medtronic Letter to My Mother campaign encourages women to make heart health a priority, starting with a conversation with their mother, or a woman in their life, about family history, risk factors, and the signs and symptoms of heart disease. The campaign, part of the company's ongoing commitment to leading and advancing clinical research for women's health, seeks to close the gap in awareness of heart disease and risks—particularly heart valve failure and high blood pressure—in women.
"The U.S. is at a tipping point when it comes to women's health, and heart health remains the deadliest concern of all," said Nina Goodheart , senior vice president and president, Structural Heart & Aortic, which is part of the Cardiovascular Portfolio at Medtronic. "At Medtronic, we're working relentlessly to ensure women receive personalized, evidence-based healthcare solutions, tailored to them. The launch of Letter to My Mother marks another step in our sustained commitment to improving health outcomes for all."
Results from the survey reveal a surprising disconnect between what women fear for their mothers or mother-figures as they age and the actual conversations happening around family health history:
"As women, we are our own best advocates, but without the confidence, knowledge, or resources to discuss our health history, we are missing out on potential life-saving conversations," said Star Jones , attorney, award-winning television personality & longtime women's heart health advocate. "I come from a family with a long history of heart disease, yet this was rarely a topic we talked about. If only I had acknowledged my risk for heart disease earlier, I could've potentially addressed my concerns with my cardiologist sooner before it led to needing open-heart surgery. That is why I am speaking out now to get all women talking about this disease and how addressing symptoms could save their life – like it did for me."
The survey also revealed that personal heart health is often overlooked by women in the sandwich generation, the population of women who bear the weight of making healthcare decisions for their children, parents, and family members. Almost all (94%) of women surveyed are responsible for making health-related decisions for loved ones, but over 60% of women find it hard to make their own health a priority.
"As physicians, we know heart health is not one size fits all. Women have a unique experience with heart disease and risk factors - like high blood pressure during pregnancy which may be the first sign of chronic high blood pressure persisting throughout their lifespan," said Dr. Raven Voora , hypertension specialist and nephrologist at UNC Health. "Too often, I've seen women present with risk factors or early signs of heart disease that they put on the backburner behind care for children and loved ones - or these signs and symptoms get brushed off as stress or anxiety. This survey shows us that patients need increased awareness and discussion surrounding heart health and to make sure they pay attention to their heart health."
This May, during Women's Health Month and timed to Mother's Day – Medtronic encourages people to take the pledge to talk to their mother or the women in their life about heart health today. For every pledge, Medtronic will make a donation to a cause that advances women's heart health.
Visit Alettertomymother.com to take the pledge and learn more.
About the Medtronic Letter to My Mother Survey:
Medtronic engaged Wakefield Research to conduct a nationally representative survey to gain insights into consumer perceptions and awareness of heart disease in women aged 30 through 50, targeted to the "daughters" who are sandwiched between taking care of their health, their children and parents. The survey was deployed among 1,000 U.S. women, ages 30 to 50, with a living mother and a living child, between March 13th and March 17th, 2025 , using an email invitation and an online survey.
Survey results are endorsed by WomenHeart: The National Coalition for Women with Heart Disease, the nation's leading voice for women living with or at risk of heart disease. WomenHeart is dedicated to promoting awareness, advocacy, and support for women with heart disease, empowering them to take charge of their heart health and improve outcomes.
About the Medtronic Letter to My Mother Campaign:
The Medtronic "Letter to My Mother" campaign aims to educate and close the gap in awareness of heart disease in women — the number one cause of death for more than a century. The campaign encourages people to start conversations with their mothers and loved ones about heart disease, including high blood pressure and heart valve failure, to better understand their family health history and risk factors. The campaign is part of the company's ongoing commitment to leading and advancing clinical research for women's health and was supported by the Medtronic Coronary & Renal Denervation and Structural Heart & Aortic businesses. To learn more about heart disease including signs, symptoms, treatment options and resources to start the conversation today, visit ALettertomyMother.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 90,000+ 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.
Contacts:
Kimberly Powell
Public Relations
+1-202-498-2601
Ryan Weispfenning
Investor Relations
+1-763-505-4626
1 Caoimhe T Rice, Sophie Barnett, Shea P O'Connell, Enoch Akowuah, Clare E Appleby, John B Chambers, Benoy N Shah, Daniel J Blackman - Impact of gender, ethnicity and social deprivation on access to surgical or transcatheter aortic valve replacement in aortic stenosis: a retrospective database study in England: Open Heart 2023;10:e002373. |
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SOURCE Medtronic plc
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Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced positive clinical outcomes from two studies in atrial fibrillation (AFib) patients treated with the Affera™ family of technologies, including the next-generation Sphere-360™ single-shot pulsed field ablation (PFA) catheter and the groundbreaking Sphere-9™ combination mapping and dual-energy focal PFA catheter. Data were presented in High Impact Science Sessions at the Heart Rhythm Society 2025 Annual Meeting in San Diego ; the Sphere-360 study was simultaneously published in the Heart Rhythm Journal .
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
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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Largest multi-center prospective Investigational Device Exemption (IDE) study for multi-port robotic-assisted urologic surgery in the U.S. presented as a late-breaker at the American Urologic Association annual meeting
Company confirms Hugo RAS system submission to the U.S. Food and Drug Administration
Medtronic (NYSE: MDT), a global leader in healthcare technology, today announced that the Expand URO Investigational Device Exemption (IDE) clinical study, the largest such study for robotic-assisted urologic surgery ever conducted, met both primary safety and effectiveness endpoints. The prospective, multi-center, single-arm IDE study included 137 patients who underwent urologic procedures using the Hugo™ robotic-assisted surgery (RAS) system.
The data, described by the American Urologic Association (AUA) as a "practice-changing, paradigm-shifting (P2) clinical trial in urology", was presented today at the AUA annual meeting in Las Vegas by Michael R. Abern , M.D., the study's national principal investigator and a urologic surgeon at Duke University Hospital in Durham, N.C.
"The study demonstrated that the Hugo RAS system met the safety and effectiveness endpoints, and the outcomes are consistent with published literature for robotic-assisted urologic surgery," said Dr. Abern. "Having performed the first case in the Expand URO clinical study, it's incredibly rewarding to see the results of this rigorous and important study in the field of robotic surgery."
About the Expand URO clinical study:
Expand URO study primary endpoint data:
"The Expand URO clinical study provides important clinical evidence about the Hugo RAS system and is an exciting milestone that brings us closer to our goal of offering surgeons in the U.S. long-awaited choice in robotic technology," said James Porter , M.D., chief medical officer, Robotic Surgical Technologies and Digital Technologies within the Surgical business, part of the Medical Surgical portfolio at Medtronic, and a urologic surgeon at Swedish Medical Center in Seattle, WA. "Surgeons want to deliver the best care to our patients and robotic technology is key to making that possible today by enabling minimally invasive surgery and leveraging technology that is shaping the future of surgery."
U.S. FDA submission for the Hugo RAS system
Medtronic also announced today that it submitted the Hugo RAS system to the U.S. Food and Drug Administration (FDA) for a urologic indication in the first quarter of calendar 2025.
The FDA submission is the company's latest milestone toward a planned entrance into the U.S., the world's largest robotic surgery market. In February, the company shared that it completed enrollment in both its hernia and benign gynecology (GYN) studies and received approval to start a new clinical study including oncologic GYN procedures — all in support of planned submissions to the FDA for additional indications beyond urology for the Hugo RAS system in the U.S.
Outside the U.S., the Hugo RAS system is in clinical use in more than 25 countries across 5 continents, with a growing body of evidence including more than 200 independent papers published to date.
Medtronic thoughtfully designed the Hugo RAS system — through collaboration with hundreds of surgeons and hospital leaders globally — with the goal of expanding access to minimally invasive care to more patients around the world. The Hugo RAS system delivers the benefits of RAS in a flexible, modular form factor and open surgeon console that supports communication among the surgical team. Paired with the Touch Surgery™ ecosystem, the Hugo RAS system offers a smart, connected surgical experience that is shaping the future of surgery. ‡
The Hugo RAS system is not cleared or approved in all markets. Regulatory requirements of individual countries and regions will determine approval, clearance, or market availability. In the U.S., the Hugo RAS system is an investigational device not for sale.
For more information, visit medtronic.com/hugo .
†The evaluation did not include assessment of outcomes related to the treatment of cancer or any specific treatment of any underlying disease or condition.
‡Touch Surgery ecosystem is not intended to direct surgery, or aid in diagnosis or treatment of a disease or condition; Live Stream and performance insights are only intended for education and training purposes.
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.
Contacts:
Gary Jeanfaivre
Public Relations
+1-203-556-0777
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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SOURCE Medtronic plc
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Adding to the Medtronic portfolio of catheter-based lead solutions, the novel OmniaSecure defibrillation lead allows for precise delivery and placement in the right ventricle
Heart Rhythm 2025: Late-breaking clinical study results evaluating the OmniaSecure lead for investigational use in the LBBAP location show high defibrillation success
Medtronic plc (NYSE: MDT), a global leader in healthcare technology, received U.S. Food and Drug Administration (FDA) approval for the OmniaSecure™ defibrillation lead for placement within the right ventricle. The lead, built on the highly reliable SelectSecure™ Model 3830 pacing lead and delivered via catheter, builds on the Medtronic portfolio of lead solutions designed for precise delivery and placement. The lead connects to an implantable defibrillator, and treats potentially life threatening ventricular tachyarrhythmias, ventricular fibrillation (VTVF) and bradyarrhythmias. As the world's smallest defibrillation lead (4.7 French, or 1.6mm), the OmniaSecure lead represents a meaningful innovation in electrophysiology, and is indicated for stimulation in the right ventricle for adults and adolescent pediatric patients ages 12 and up, including those with smaller anatomies.
Separately, the company is also studying placing the novel, small-diameter OmniaSecure defibrillation lead in the left bundle branch (LBB) area, which has the potential to enable physiologic pacing to more closely mimic the heart's natural conduction system. Investigational outcomes of this study were presented at Heart Rhythm 2025 in San Diego . The results from the study demonstrate high defibrillation success of 100% at implant when the lead is implanted in the LBB area. Globally, the OmniaSecure defibrillation lead is investigational for use in LBB area and requires FDA approval in the future.
Implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) are the standard for preventing sudden cardiac death. The ICD/CRT-D connects to a defibrillation lead (insulated electrical wire) that forms the electrical conduit between the device and the heart. The lead senses the heartbeat, and transmits signals to the implanted device, which then delivers therapy to correct or interrupt abnormally fast rhythms. The lead must flex with millions of heart contractions over a lifetime.
Existing defibrillation leads are larger in diameter than the OmniaSecure lead. A larger-diameter lead may increase the potential for downstream complications, such as venous occlusion or tricuspid valve regurgitation.
"FDA approval for the OmniaSecure defibrillation lead furthers our ability to offer physicians and patients a transvenous solution designed to be smaller to help minimize complications−including vascular complications and valve interaction−with strong, reliable lead durability. We engineered the OmniaSecure lead based on the trusted SelectSecure Model 3830 pacing lead, which has been the lead of choice for many physicians for more than 20 years," said Alan Cheng , M.D., chief medical officer of the Cardiac Rhythm Management business, which is part of the Cardiovascular Portfolio at Medtronic. "This milestone underscores our commitment to driving clinical innovations that help patients today while paving the way for future innovations that will usher in the next era of electrophysiology."
Previously, researchers presented late breaking data from the global Lead Evaluation for Defibrillation and Reliability (LEADR) Pivotal Trial showing the OmniaSecure defibrillation lead met its primary safety and effectiveness endpoints and exceeded prespecified performance goals when placed within the right ventricle. The results were presented during Heart Rhythm 2024, simultaneously published in Heart Rhythm , and are the basis of FDA approval for the traditional right ventricular lead placement indication.
Late-Breaking LEADR LBBAP Results Presented at Heart Rhythm 2025
Researchers presented late-breaking results at Heart Rhythm 2025 for the LEADR LBBAP (Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing) study that showed the OmniaSecure defibrillation lead demonstrated high defibrillation success when placed in the LBB area for patients indicated for an ICD or CRT-D. Placing the defibrillation lead in the LBB area is being evaluated as an alternative to right ventricular stimulation for sensing, pacing, cardioversion and defibrillation.
Defibrillation testing conducted in 162 patients at device implantation was successful in 100% of cases, with the study meeting the prespecified efficacy goal of 88%. Of the first 193 patients implanted in the study, the OmniaSecure lead was successfully implanted per protocol in 95.8% of the procedures as reported by physician investigators. There were no procedure-related major complications such as early helix or lead fracture, system revision, or death.
"The left bundle branch area is emerging as an option for more physiologic pacing for patients who receive an ICD or CRT-D to treat dangerous heart rhythms," said Pugazhendhi Vijayaraman, M.D., cardiac electrophysiologist at Geisinger Wyoming Valley Medical Center in Wilkes-Barre, Pa. , who presented the data at the meeting. "The option to place a lead in the left bundle branch area may provide for physiologic pacing by engaging the heart's natural conduction system. These positive preliminary results for the LEADR LBBAP study are encouraging and highlight the potential versatility of the OmniaSecure defibrillation lead."
The LEADR LBBAP trial is a global, prospective, non-randomized, multi-center study. The study has enrolled approximately 300 patients at 24 sites in 11 countries in North America , Europe , Asia and Australia . Patients enrolled in the study indicated for an ICD are being followed out to 3 months while patients indicated for CRT-D are being followed out to 6 months post-implant.
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.
Contacts:
Joey Lomicky
Public Relations
+1-763-526-2494
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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SOURCE Medtronic plc
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Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced it has submitted 510(k) applications to the U.S. Food and Drug Administration (FDA) seeking clearance for an interoperable pump. FDA clearance of this pump would pave the way for system integration with a continuous glucose monitoring (CGM) sensor based on Abbott's most advanced CGM platform.
The submissions included a 510(k) application for its MiniMed™ 780G pump as an alternate controller enabled (ACE) insulin pump and a separate 510(k) application for its SmartGuard™ algorithm as an interoperable automated glycemic controller (iAGC).
"We understand how meaningful these advancements are, and we're working with urgency to bring enhanced CGM options to our customers," said Que Dallara, EVP & president, Medtronic Diabetes. "This collaboration with Abbott marks an important step forward in providing innovative solutions and more choice for our customers."
This milestone follows the announcement last August that the companies will collaborate on an integrated system based on Abbott's most advanced CGM platform. Abbott will supply Medtronic with a CGM that will work exclusively with Medtronic smart dosing devices and software across both automated insulin delivery and smart multiple daily injections systems. These systems, including the Abbott CGM, will be sold exclusively by Medtronic.
More details will be shared when FDA clearance is secured.
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:
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Public Relations
+1-818-403-7028
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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SOURCE Medtronic plc
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