A new FDA-approved labeling could bolster more support for the use of Somanetics' (Troy, Michigan) In-Vivo Optical Spectroscopy (INVOS) system. The company reported the new labeling yesterday, saying that it allows a claim of improved patient outcomes after surgery when the technology is used to manage therapies in patients above 2.5 kilograms at risk for reduced or absent blood flow.
Additionally, the indications for use now reflect the INVOS system's ability to generate accurate real-time measurements of blood oxygen saturation in this same patient population, in addition to its previous clearance as a trend monitor in any individual.
The company noninvasively monitors site-specific blood oxygen levels to help surgical and critical care teams protect their patients against brain and vital organ area damage, or even death. Surgeons, anesthesiologists, intensive-care nurses and other medical professionals can use the information provided by the INVOS to identify oxygen imbalances in tissues beneath the sensor and take necessary corrective action, potentially improving patient outcomes and reducing the costs of care.
"The clinical data we submitted and subsequent 510(k) clearance demonstrate that improved patient outcomes are possible with the use of our INVOS system, and that our device can benefit cardiac surgery patients as well as high-risk general surgery patients, such as the elderly undergoing major abdominal surgery," Bruce Barrett, Somanetics' president/CEO, told Medical Device Daily.
Barrett continues, "Our expanded indication reinforces the device's applicability for on-label treatment of patients at any weight. For patients above 2.5 kilograms, including adults, children and most infants, our proprietary algorithm generates accurate, real-time measurements for immediate use by the care team. In patients below 2.5 kilograms, which is extremely common in our neonatal market, clinicians may use our device on-label as a trend monitor."
The system uses near-infrared spectroscopy, also known as NIRS, a noninvasive technology. The sensors simply stick to the skin like a Band-Aid. Once the sensor is placed on the skin, harmless, near-infrared light is emitted which passes through the skin and bone to monitor the blood oxygen level of deeper tissue, such as the brain, organs and muscle tissue.
Care teams can place up to four sensors on a patient. The vital sign generated is called regional oxygen saturation, or rSO2. The care team tries to maintain the rSO2 within a healthy range. When they see rises and falls in the number, they administer a number of interventions to try and restore adequate oxygenation.
INVOS was first approved in 1996 and has since had a host of indications and labelings approved by the FDA.
"Right now we're set with out labeling," Barrett told MDD. "In general we're where we want to be with our labeling right now."
According to the company the system is used in more than 700 U.S. hospitals, including 80% of hospitals performing pediatric cardiac surgery. There are also more than 1,200 INVOS system installs around the world, according to the company. The monitor is used in 210,000 procedures annually.
The system may be used on any individual; defined as adults, children, infants and neonates who are at risk of reduced-flow or no-flow ischemic states.
It may be used by a variety of surgeons, anesthesiologists, nurses and other clinicians throughout the hospital, with the most common areas being the operating room, pediatric and neonatal intensive care units, interventional cardiac catheterization labs and the emergency room.
For adults, published clinical benefits include reductions in major organ morbidity or mortality, stroke, post-operative cognitive difficulties, respiratory failure/ventilation time, adverse cardiac events and coma. For children, infants and neonates, reported clinical benefits include enhanced detection of oxygen threats associated with low cardiac output, renal failure, neurologic damage, shock and seizures.
For the care team, the INVOS system also helps identify patient-unique physiology that may have gone unnoticed prior to surgery or intensive care.
The system also shows care teams patient-specific responses throughout each stage of surgical or intensive care, and patient responses to interventions so the efficacy of treatment can be assessed and customized for each patient.