News Story #16602

The Diametrics development team and Agilent’s Greg Sebasky (second from left). Left to right: Roy Johnson; Greg Sebasky, vice president, Agilent Technologies New Clinical Ventures; Roger Pamment; and Barry Crane

In Level 3 neonatal care units, size matters. Weight, lung capacity and blood volume directly impact each baby’s quality and length of life.

So any device that helps prevent blood transfusions and simultaneously provides critical life support data is a welcome armament for neonatologists battling to keep these tiny humans alive. The Neotrend continuous blood gas sensor and its Trendcare monitor use four fiber optic threads to do just that.

Neotrend eliminates the need – and crucial time – to draw blood from a premature baby and run it to the lab for analysis. The sensor, inserted through an umbilical artery catheter in the infant’s descending aorta, monitors pH, PCO2, PO2 and temperature in the baby’s blood through fiber optic cables, each less than 0.007mm, encased in an outer sheath of less than 0.5mm diameter. This information is crucial to keeping the child properly ventilated.

“Blood gas and temperature monitoring is critical in stabilizing critically ill newborns,” said Roy Johnson, executive vice president and managing director of Diametrics Medical Ltd. in Great Britain, where the company’s research facilities are located. “In ventilation therapy, if infants receive improper levels of oxygen or their carbon dioxide levels change too rapidly, complications such as permanently impaired vision, brain damage or cerebral hemorrhage may occur. Neotrend is the first and only product to provide direct, continuous monitoring of these blood gases while minimizing the need to draw blood. This is essential given the small blood volume of premature infants.”

David T. Giddings, CEO of Diametrics Medical Inc., manufacturer of Neotrend and Trendcare, sees the technology as the Holy Grail of treatment for critically ill premature babies. “In the late ‘80s and early ‘90s, 20 companies were attempting to develop in vivo fiber optic sensors to continually monitor blood gases,” Giddings said. “Cumulatively they spent a billion dollars trying to make this technology into a solution. The bottom line, the only company that technically succeeded was Pfizer.”

Formed in 1990, Diametrics specialized in a thick-film sensor technology that allowed for testing at the bedside. By 1996, its focus on the critical care market led the company to acquire the fiber optic sensor platform from Pfizer, which was divesting its medical device unit and focusing on pharmaceuticals. The device received FDA clearance in December 1999. Diametrics also manufactures Paratrend, a similar device for use in adult and pediatric care that feeds into the radial or femoral artery. Agilent Technologies, a company created from Hewlett-Packard’s medical division, has exclusive global sales, marketing and distribution rights for Neotrend, Paratrend and Trendcare.

“The inclusion of the Trendcare monitor and its Neotrend sensor in Agilent Technologies’ portfolio is representative of our company’s strategic mission,” said Greg Sebasky, vice president of Agilent’s New Clinical Ventures, which includes point of care diagnostics. “Our aim is to bring to market new and innovative technology tools that help caregivers make significant clinical improvements. Neotrend introduces a completely different use model for delivering crucial information when, where, and how it’s required. No other technology can approximate its capabilities to make such a difference in the care of critically ill patients.”

“A preemie born at 26 weeks gestation or less is ventilator dependent,” Giddings said, “continuously monitoring the blood gases gives caregivers the ability to know, in real time, what’s happening to the neonate so that medication and ventilation can be precisely administered.” It’s not enough to save the baby. The goal is to save the baby, so the child can live without lifelong complications.”

The key developers of Neotrend were Roy Johnson, executive VP and managing director; Barry Crane, head of R&D and CTO; Roger Pamment, director, international sales and marketing; Jon Church, project manager; and David Markle, principal scientist.

Santa Clara Valley Medical Center in San Jose, Calif., was the first U.S. hospital to use Neotrend. Clinicians there laud its capability to continuously deliver crucial blood-gas information and eliminate the time – 15 minutes to an hour – spent waiting for the lab analysis.

“Laboratory analysis provides historical information. You get a piece of data that is basically outdated rather than a continuous readout,” said Ron Cohen, MD, chief of neonatology at Valley Medical Center, and clinical associate professor of pediatrics at Stanford University. Neotrend lets you know of a problem before you suspect it. It’s picked up instantly. Other technologies give you similar data, but for the smallest and sickest kids, nothing is as simple and accurate as this.”

Cohen has worked with the basic technology as it has changed hands and ownership over the years. “This is a new variation of a neocatheter that was available in the past,” Cohen said. “But [the old one] didn’t measure whole blood gas. This is a much better technology, with a much nicer catheter.”

How many sick neonates have healthier lives as a result of this technology? Johnson said, “It’s hard to say, but users find it difficult to stop themselves from making public statements that it does save lives. Preemies are so incredibly fragile, if you can monitor the blood gases, you can eliminate some very serious problems.”