Medtronic INVOS 7100 Cerebral/Somatic Oximetry System receives 510 clearance for pediatric indications

FDA clearance expands use of the INVOS™ 7100 system, helping clinicians better monitor organ-specific oxygen levels and identify warnings signs for neonates and children earlier

- Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its INVOS™ 7100 cerebralsomatic oximetry system for children from birth through age 18. The INVOS system picks up key signals to inform time-critical decisions by pediatric clinicians related to hemodynamic management, ventilation, and resuscitation for premature infants, neonates, children, and other patients treated by pediatric clinicians.

"Timing is critical for vulnerable pediatric patients, and the INVOS™ 7100 system can alert clinicians to changes in patient condition before traditional monitored parameters even react," 1, 2 said Frank Chan , president of the Patient Monitoring business, which is part of the Medical Surgical Portfolio at Medtronic. "The INVOS™ 7100 system can help clinicians decide if intervention is necessary — a core component in successful outcomes. And our technology consistently enables users to determine if they need to intervene sooner." 1-6

The INVOS™ near-infrared spectroscopy monitoring system has been previously cleared for use in adult patients and is the clinical reference standard for regional oximetry. 7 The real-time measures of tissue perfusion and oxygenation provided by the INVOS™ 7100 system provide early alerts to changes in perfusion before other vital sign measurements. 1, 2 This data may indicate to clinicians that a patient is becoming critical — providing them the crucial time needed to treat newborns and young patients.

"There are so many time-critical conditions clinicians face when treating some of our youngest patients in intensive care units, from RSV to complex heart conditions and beyond. We see this as an opportunity to equip providers with technology that can help improve outcomes among the most vulnerable populations," said Sam Ajizian , MD, FAAP, FCCM, CPPS, and chief medical officer of the Patient Monitoring business at Medtronic. "We are thrilled that the INVOS™ 7100 system has been cleared for pediatric indications."

The technology inside the INVOS™ 7100 system delivers first-alert performance with its unique algorithms that measure acute alterations in hemodynamics, regional oxygen saturation, and oxygen metabolism. 1, 2 The system provides continuous, noninvasive readings of organ-specific regional blood oxygen levels in up to four site specific areas chosen by the care team and oxygen saturation from vascular beds to assess organs individually, or in combination to track brain/body perfusion shifts.

The INVOS™ 7100 system with the pediatric indications will be available worldwide for commercial use in spring 2022.

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 90,000+ 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 Twitter and 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.

The INVOS™ monitoring system should not be used as the sole basis for diagnosis or therapy and is intended only as an adjunct in patient assessment.

1.

Lu Y, Di M, Li C, Chen M, Yuan K, Shangguan W. Comparing the response of pulse oximetry and regional cerebral oxygen saturation to hypoxia in preschool children. Exp Ther Med . Jan 2020;19(1):353-358. doi:10.3892/etm.2019.8199

2.

Tobias JD. Cerebral oximetry monitoring with near infrared spectroscopy detects alterations in oxygenation before pulse oximetry. J Intensive Care Med . Nov-Dec 2008;23(6):384-8. doi:10.1177/0885066608324380

3.

Alderliesten T, Lemmers PM, van Haastert IC, et al. Hypotension in preterm neonates: low blood pressure alone does not affect neurodevelopmental outcome. J Pediatr . May 2014;164(5):986-91. doi:10.1016/j.jpeds.2013.12.042

4.

Bonestroo HJ, Lemmers PM, Baerts W, van Bel F. Effect of antihypotensive treatment on cerebral oxygenation of preterm infants without PDA. Pediatrics . Dec 2011;128(6):e1502-10. doi:10.1542/peds.2010-3791

5.

Chock VY, Kwon SH, Ambalavanan N, et al. Cerebral Oxygenation and Autoregulation in Preterm Infants (Early NIRS Study). J Pediatr . Dec 2020;227:94-100.e1. doi:10.1016/j.jpeds.2020.08.036

6.

Pichler G, Urlesberger B, Baik N, et al. Cerebral Oxygen Saturation to Guide Oxygen Delivery in Preterm Neonates for the Immediate Transition after Birth: A 2-Center Randomized Controlled Pilot Feasibility Trial. J Pediatr . Mar 2016;170:73-8.e1-4. doi:10.1016/j.jpeds.2015.11.053

7.

Yu Y, Zhang K, Zhang L, Zong H, Meng L, Han R. Cerebral near-infrared spectroscopy (NIRS) for perioperative monitoring of brain oxygenation in children and adults. Cochrane Database Syst Rev . Jan 17 2018;1(1):Cd010947. doi:10.1002/14651858.CD010947.pub2

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Investor Relations

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SOURCE Medtronic plc

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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.

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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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