Late-breaking data show reliable performance of small-diameter defibrillation lead, the Medtronic OmniaSecure

Global LEADR clinical trial meets safety and effectiveness objectives; results presented at Heart Rhythm 2024 and simultaneously published in Heart Rhythm

- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, announced that its investigational OmniaSecure™ defibrillation lead met its primary safety and effectiveness endpoints, exceeding prespecified performance goals, in the global Lead Evaluation for Defibrillation and Reliability (LEADR) Pivotal Trial. Late breaking results were presented at Heart Rhythm 2024 and simultaneously published in the journal Heart Rhythm . Worldwide, the OmniaSecure defibrillation lead is investigational and not yet approved for sale or distribution.

Implantable cardioverter defibrillators (ICDs) are the gold standard for preventing sudden cardiac death. Yet transvenous defibrillator leads, which are thin wires connected to the ICD and threaded through the veins into the heart muscle, remain the weakest point of the system, 1 given the harsh environment inside the human body where the lead must remain attached and yet flex with millions of heart contractions over a patient's lifetime. Existing defibrillation leads have a large diameter (7-8 French), which can contribute to venous occlusion or tricuspid valve complications.  For patients where an extravascular defibrillator may not be appropriate, Medtronic engineers designed the OmniaSecure defibrillation lead based on the Medtronic SelectSecure™ Model 3830 pacing lead, which has offered safe and effective treatment to patients for more than 20 years. By beginning with this highly reliable pacing lead and building a larger lead suitable for defibrillation therapy, the Medtronic OmniaSecure lead is the world's smallest transvenous defibrillation lead (4.7 French, equivalent to the diameter of graphite in a wooden pencil).

LEADR Primary Results: Effectiveness  
Defibrillation testing conducted at device implantation in 119 patients was successful in 97.5% of cases. The study exceeded the prespecified efficacy goal of 88%.

LEADR Primary Results: Safety  
At six months, 97.1% (Kaplan-Meier estimate) of 657 patients with an implant attempt were free from lead-related major complications such as hospitalization, lead fracture, system revision, or death. The study exceeded the prespecified safety performance goal of 90%. There were no lead-related major complications observed between six and 12 months (average follow up of 12.7±4.8 months).

"The positive results from the LEADR Pivotal trial are a significant advancement for patients at risk of sudden cardiac death who rely on ICDs to deliver life-saving therapy in the event of a dangerous heart rhythm," said George H. Crossley , M.D., Director of the Electrophysiology Lab and Cardiac Research Enterprise, Vanderbilt University Medical Center, Nashville, Tenn. , and LEADR Pivotal trial steering committee chair. "Patients with defibrillators are living longer today, and we need to strive for reliable therapy for the lifetime of the patient. This innovative, low-profile defibrillation lead leverages a highly reliable pacing lead design to help achieve this goal, and the unique catheter-based method of implantation helps the physician place the lead in the optimal position for the patient."

The LEADR Pivotal trial is a prospective, multicenter, single-arm, non-randomized, global clinical study that assessed the safety and effectiveness of the Medtronic OmniaSecure defibrillation lead when placed at traditional locations in the right ventricle to achieve defibrillation, sensing, pacing and cardioversion in patients at risk of sudden cardiac death. The study enrolled 675 patients at 45 sites in 17 countries in North America, Europe , Asia , and Australia .

Secondary and Ancillary Results: Reliability
The lead demonstrated reliable performance with zero (0) study lead fractures through an average follow up of 12.7±4.8 months. Medtronic developed and validated an in-vitro model that accurately predicts lead reliability out to 10 years, 2 and then applied that model within the study to predict a fracture-free survival of 99.9% at two years for the investigational OmniaSecure lead. The lead also demonstrated a 97.9% implant success rate, and stable electricals (R-wave, pacing capture threshold, and pacing impedance) through 12 months.

Nearly 12% of patients in the study received appropriate therapy (shock, or anti-tachycardia pacing [ATP]) for dangerously fast ventricular arrhythmias by 14.0±5.0 months. ATP terminated 74.9% of episodes, preventing a shock in 49 patients.

Medtronic plans to present additional reliability model results from the LEADR study in the coming months.

"For 75 years, Medtronic has innovated to bring better life-saving technologies to the patients who need them," said Alan Cheng, M.D., chief medical officer of the Cardiac Rhythm Management business, which is part of the Cardiovascular Portfolio at Medtronic. "Given our history in working with health care providers to design technology for patients with arrhythmias, we applied learnings from our deep experience with both transvenous defibrillation and pacing leads to create the novel OmniaSecure lead, a catheter-delivered lead that can be placed in the desired location. The LEADR study results are an encouraging step forward in achieving the goal of an even more reliable defibrillation lead for patients."

In addition to the LEADR results presented at Heart Rhythm 2024, Medtronic recently initiated the LEADR LBBAP study (Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing), which is assessing the safety and efficacy of the investigational OmniaSecure defibrillation lead when placed at the Left Bundle Branch Area in patients eligible for an ICD or Left Bundle Branch-Optimized Cardiac Resynchronization Therapy (LOT-CRT). Placing the defibrillation lead in the left bundle branch area is being evaluated as an alternative to right ventricular stimulation for sensing, pacing, cardioversion and defibrillation. First implants were recently conducted by Muhammad Afzal , M.D., MBBS, principal investigator at The Ohio State Medical Center Wexner Medical Center, and John Zakaib , M.D., principal investigator at Minneapolis Heart Institute Foundation.

About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, 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 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.

1

Swerdlow CD, Kalahasty G, Ellenbogen KA. Implantable Cardiac Defibrillator Lead Failure and Management. J Am Coll Cardiol 2016;67:1358-1368

2

Wilkoff, Bruce L., et al. In vitro modeling accurately predicts cardiac lead fracture at 10 years. Heart Rhythm 18.9 (2021): 1605-1612.

Contacts:


Tracy McNulty

Ryan Weispfenning

Public Relations

Investor Relations

+1-763-526-2492

+1-763-505-4626

(PRNewsfoto/Medtronic plc)

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SOURCE Medtronic plc

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Colin.Jackson@atco.com
(403) 808 2636

Media Inquiries:
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Kurt.Kadatz@atco.com
(587) 228 4571

SOURCE ATCO Ltd.

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Solventum Announces Sale of its Purification & Filtration Business to Thermo Fisher Scientific Inc. for $4.1B

  • Accelerates Solventum's business transformation and sharpens focus on strategic areas for growth to deliver long-term shareholder value

  • Strengthens balance sheet with proceeds to be used primarily for debt paydown

Solventum (NYSE: SOLV) today announced it has entered into a definitive agreement to sell its Purification & Filtration 1 business to Thermo Fisher Scientific Inc. (NYSE: TMO) (" Thermo Fisher ") for $4.1 billion . Solventum expects the transaction to be neutral to 2025 EPS and expects an estimated $3.4 billion in net proceeds, which it intends to use primarily to pay down debt. The transaction is expected to be completed by the end of 2025, subject to regulatory approval and customary closing conditions.

Solventum Logo (PRNewsfoto/3M Healthcare US Opco LLC)

"The sale of the Purification & Filtration business is part of phase three of our transformation plan and follows a thorough analysis of the value and strategic alignment of our businesses," said Bryan Hanson , Solventum CEO. "This transaction will enhance our strategic focus and key metrics while reducing leverage and significantly strengthening our balance sheet. It also enables us to invest in the innovation, programs and talent we need to execute our mission and deliver shareholder value."

Mr. Hanson continued, "Solventum is committed to ensuring a smooth transition for employees, customers and other stakeholders, and we are confident that Thermo Fisher will provide the Purification & Filtration business – which offers filters and membranes for use in the manufacturing of biopharmaceutical and medical technologies, microelectronics and food, beverage products and drinking water – the strategic investment and resources needed for sustaining growth and delivering customer solutions."

Solventum will discuss the transaction on its upcoming fourth quarter and full-year 2024 earnings call scheduled for February 27, 2025 . With this significant change in the Company's portfolio and the other major actions taken since becoming an independent publicly traded company on April 1, 2024 , Solventum has scheduled an Investor Day on March 20, 2025 , to provide investors with an update on the progress made, its go-forward positioning and long-range plan. The Investor Day will be held in New York City , and the Company will share additional logistical details in due course.

Morgan Stanley & Co. LLC, Perella Weinberg Partners and J.P. Morgan Securities LLC served as financial advisors to Solventum, and Cleary Gottlieb Steen & Hamilton served as legal advisor to Solventum.

1 Other than for its operations in Belgium , France and Ireland , for which Thermo Fisher granted a binding offer to Solventum

About Solventum  
At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers' toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better — while empowering healthcare professionals to perform at their best. See how at Solventum.com .

Forward-Looking Statements
This news release contains forward-looking information about Solventum's financial results, estimates, and business prospects that involve substantial risks and uncertainties. In particular, statements regarding the future performance of Solventum, including guidance for 2024, are forward-looking statements. You can identify these statements by the use of words such as "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "guidance," "intends," "may," "outlook," "plans," "projects," "seeks," "sees," "should," "targets," "will," "would," and other words and terms of similar meaning in connection with any discussion of future operating or financial performance or business plans or prospects. Among the factors that could cause actual results to differ materially are the following: (1) the effects of, and changes in, worldwide economic, political, regulatory, international, trade and geopolitical conditions, natural disasters, war, public health crises, and other events beyond Solventum's control; (2) operational execution risks; (3) damage to our reputation or our brands; (4) risks from acquisitions, strategic alliances, divestitures and other strategic events; (5) Solventum's business dealings involving third-party partners in various markets; (6) Solventum's ability to access the capital and credit markets and changes in Solventum's credit ratings; (7) exposure to interest rate and currency risks; (8) the highly competitive environment in which Solventum operates and consolidation in the healthcare industry; (9) reduction in customers' research budgets or government funding; (10) the timing and market acceptance of Solventum's new product and service offerings; (11) ongoing working relationships with certain key healthcare professionals; (12) changes in reimbursement practices of governments or private payers or other cost containment measures; (13) Solventum's ability to obtain components or raw materials supplied by third parties and other manufacturing and related supply chain difficulties, interruptions, and disruptive factors; (14) legal and regulatory proceedings and legal compliance risks (including third-party risks) with regards to antitrust, Foreign Corrupt Practices Act (FCPA) and other anti-bribery laws, environmental laws, anti-kickback and false claims laws, privacy laws, tax laws, and other laws and regulations in the United States and other countries in which Solventum operates; (15) potential liabilities related to a broad group of perfluoroalkyl and polyfluoroalkyl substances, collectively known as "PFAS"; (16) risks related to the highly regulated environment in which Solventum operates; (17) risks associated with product liability claims; (18) climate change and measures to address climate change; (19) security breaches and other disruptions to information technology infrastructure; (20) Solventum's failure to obtain, maintain, protect, or effectively enforce its intellectual property ("IP") rights; (21) pension and postretirement obligation liabilities; (22) any failure by the 3M Company (" 3M ") to perform any of its obligations under the various separation agreements in connection with the separation from 3M (the "Spin-Off"); (23) any failure to realize the expected benefits of the Spin-Off, and/or that the Spin-Off will not be completed within the expected time frame, on the expected terms or at all; (24) a determination by the IRS or other tax authorities that the distribution or certain related transactions should be treated as taxable transactions; (25) expected financing transactions undertaken in connection with the separation and risks associated with additional indebtedness; (26) the risk that incremental costs of operating on a standalone basis (including the loss of synergies), costs of restructuring transactions and other costs incurred in connection with the separation will exceed Solventum's estimates; and (27) the impact of the Spin-Off on its businesses and the risk that the Spin-Off may be more difficult, time-consuming or costly than expected, including the impact on its resources, systems, procedures and controls, diversion of management's attention and the impact on relationships with customers, suppliers, employees and other business counterparties.

Changes in such assumptions or factors could produce significantly different results. A further description of these factors is located under "Cautionary Note Regarding Forward-Looking Statements" and "Risk Factors" in Solventum's periodic reports on file with the U.S. Securities & Exchange Commission. Solventum assumes no obligation to update any forward-looking statements discussed herein as a result of new information or future events or developments.

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SOURCE Solventum

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