Medtronic plc

Built for high reliability, world's only lumenless defibrillation lead approved for placement in the left bundle branch area

GALWAY, Ireland, March 23, 2026 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, received U.S. Food and Drug Administration (FDA) approval for an expanded indication for the OmniaSecure™ defibrillation lead. Now approved for placement in the left bundle branch (LBB) area, the lead can be used for conduction system pacing (CSP), which closely mimics the heart's natural physiology. Additionally, patients in need of cardiac resynchronization may benefit from left bundle branch optimized cardiac resynchronization therapy (LOT-CRT), a novel therapy that combines CSP with left-ventricular pacing to further improve patient outcomes.

The OmniaSecure defibrillation lead connects to an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) to treat potentially life-threatening ventricular tachyarrhythmias, ventricular fibrillation (VT/VF), and bradyarrhythmias. In addition to being the first defibrillation lead approved for placement in the LBB area, the OmniaSecure lead is the smallest diameter defibrillation lead on the market (4.7 French, or 1.66 mm) and the only one approved for adults and adolescent pediatric patients ages 12 and up.

Engineered based on the reliable Medtronic SelectSecure™ Model 3830 pacing lead − the first pacing lead to receive FDA approval for CSP in 2022 − the OmniaSecure defibrillation lead is built for high reliability and durability with its lumenless construction (no hollow channel on the inside), which enables the lead to be delivered via catheter for precise placement in the right ventricle, in addition to the LBB area. Conduction system pacing works by tapping into the heart's natural electrical system, providing patients needed therapy while avoiding cardiomyopathy or other complications sometimes associated with traditional pacing methods.¹

"Conduction system pacing is a rapidly growing therapy for patients who need a pacemaker. Now, patients who require a defibrillator and pacing have an option that can safely deliver life-saving defibrillation therapy and activate the heart's natural electrical system to enable a more synchronous, physiologic pattern," said Trevor Cook, vice president and general manager of the Defibrillation Solutions business, which is part of the Cardiac Rhythm Management operating unit at Medtronic. "This approval underscores the versatility of the OmniaSecure defibrillation lead and supports its use across a variety of implant approaches to best serve a broad range of patients."

ICDs and CRT-Ds are the gold standard for preventing sudden cardiac arrest. For patients who require chronic pacing and defibrillation therapy, the OmniaSecure lead can offer treatment for dangerously fast arrhythmias while delivering conduction system pacing through the LBB area, when connected to a transvenous ICD or CRT-D, such as the Medtronic Cobalt™ and Crome™ family of devices. Patients indicated for CRT may benefit when OmniaSecure is paired with a left ventricular coronary sinus lead (i.e., biventricular or LOT-CRT configurations). For patients who do not require chronic pacing, the Medtronic extravascular Aurora EV-ICD™ system offers protection as the only ICD with a defibrillation lead positioned outside the vascular space that also provides anti-tachycardia pacing (ATP) in a single device.

FDA approval for the OmniaSecure defibrillation lead was supported by data from the global LEADR LBBAP trial (Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing), which demonstrated the lead's safety and effectiveness. Late-breaking data from the study presented at Heart Rhythm 2025, and later published in Heart Rhythm, showed that the lead delivered high defibrillation success at implant (100%) and a low OmniaSecure-related major complication rate at three months (2.1%) when placed in the LBB area for physiologic pacing.² Longer-term LBB area and LOT-CRT results from the study will be presented at HRS 2026.

"The robust body of clinical evidence from the LEADR LBBAP study supports the OmniaSecure defibrillation lead as a safe and effective way to activate physiologic pacing through the left bundle branch area or in applications like LOT-CRT, while also demonstrating reliable defibrillation success," said Pugazhendhi Vijayaraman, M.D., cardiac electrophysiologist at Geisinger Wyoming Valley Medical Center in Wilkes-Barre, Pa., and principal investigator of the LEADR LBBAP study.

The approval expands the comprehensive Medtronic portfolio of lumenless leads and accessories approved by FDA that enable conduction system pacing. This includes the SelectSecure Model 3830 pacing lead, now implanted in more than one million patients globally, as well as the recently cleared C320LBB delivery catheter and the 5944RL rotatable connector. Together, these CSP solutions deliver stability and long-term performance that further enhance procedural precision and versatility.

Following FDA approval for placement in traditional locations in the right ventricle, the OmniaSecure defibrillation lead launched commercially in the U.S. in January 2026.

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. 

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SOURCE Medtronic plc

Deal complements Medtronic's Neurovascular portfolio, delivering simplicity and access when 'time is brain'

GALWAY, Ireland, March 10, 2026 /PRNewswire/ -- Medtronic today announced its entry into a definitive agreement to acquire Scientia Vascular, a company with critical, innovative technology across the neurovascular portfolio. The acquisition is valued at $550 million, subject to customary adjustments, with potential undisclosed earn-out and milestone payments post-acquisition.

Scientia is a private company operating in Salt Lake City, Utah, with approximately 310 employees. Under founder and current chief technology officer John Lippert, the company has developed best-in-class access products that enable simplicity and access for physicians treating complex neurovascular conditions. Scientia's portfolio of guidewires and catheters can be seamlessly integrated with Medtronic's existing suite of neurovascular products, strengthening the company's ability to support physicians across the full procedural workflow.

In stroke treatment, every second matters. With each second of restricted blood flow, the brain loses millions of brain cells. Today, stroke is the third leading cause of death and leading cause of disability worldwide. 

Unlike vessels in many other parts of the body, cerebral vasculature is highly complex and tortuous, creating significant challenges for physicians attempting to reach the site of an occlusion or aneurysm. Difficult access can delay therapy delivery and impact procedural success.

Scientia's novel access platform is designed to address these challenges by improving navigability through complex anatomy and simplifying neurovascular procedures. By enabling faster and more reliable access, these technologies improve procedural efficiency.

"Medtronic is thrilled to acquire Scientia to accelerate meaningful innovation in neurovascular care," said Linnea Burman, senior vice president and president of Medtronic's Neurovascular business, which is part of the Neuroscience Portfolio at Medtronic. "This acquisition positions Medtronic with a full suite of products. It builds a strong foundation for Medtronic and supports procedures across both hemorrhagic and acute ischemic stroke. Medtronic's best-in-class therapies, combined with Scientia's leading access portfolio, will be incredibly powerful. With 12 million people globally suffering from stroke each year, we look forward to contributing to better patient outcomes around the world." 

"As a company committed to improving patients' lives, we are humbled and excited for what's ahead," said Rick Randall, CEO, Scientia. "Scientia has developed critical technology that has been embraced by physicians. This deal allows us to take our engineering into disease states globally and positions Medtronic with a comprehensive portfolio and complete guidewire line. With the size and scale of Medtronic, the opportunity to treat more patients and drive more impact is truly exciting."

"Microwires and microcatheters are required for all neurointerventional cases," said Dr. David Fiorella, director of the Cerebrovascular Center at Stony Brook Medicine. "Correspondingly, better microwires and microcatheters make every single case technically easier, faster and ultimately safer for patients. This revolutionary microwire technology has enabled – and will continue to enable – access and simplify the neurovascular procedures we do."

This acquisition is expected to close in the first half of FY27, subject to regulatory approvals and satisfaction of other closing conditions. It is expected to be minimally dilutive to Medtronic adjusted EPS in FY27 and accretive thereafter.

About the Neurovascular Business at Medtronic 

Medtronic helped create the neurovascular market – introducing innovations like liquid embolic, stent retrievers, and flow diverters. Today, with products covering multiple conditions and disease states, we work to eliminate the burden of stroke and other neurovascular diseases globally by transforming care, one breakthrough at a time. Together with our partners, including physicians, hospitals, governments and patients, we're expanding into new disease states and stages of care. Our unwavering focus on better outcomes fuels our drive to deliver life-changing therapies and transform the future of care for patients worldwide. For more information, follow Medtronic Neurovascular on LinkedIn.

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, 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, 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.

View original content to download multimedia:https://www.prnewswire.com/news-releases/medtronic-to-acquire-scientia-vascular-marrying-access-and-therapeutic-portfolios-for-neurovascular-care-302708767.html

SOURCE Medtronic plc