Medtronic’s INVOS 7100 Cerebral/Somatic Oximetry Gains Pediatric FDA Nod

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Medtronic’s INVOS 7100 cerebral/somatic 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 Medtronic’s Patient Monitoring business. “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.
 
References
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