The US Food and Drug Administration (FDA) has issued 510(k) clearance for the Ivenix Infusion System, ushering in a new era of infusion systems designed to make infusions safer, while lowering the total cost of ownership.


Image: Ivenix Infusion System wins 510(k) clearance from FDA. Photo: Courtesy of Ivenix, Inc‏/Twitter

Ivenix looks to disrupt the $4.7 billion North American infusion market, which has been fraught with dangerous and costly errors associated with legacy technologies. The Ivenix Infusion System is the first and only large-volume pump and infusion system designed from the ground up to meet the new FDA infusion pump guidelines, adopted in 2014 to address the recurring safety problems associated with infusion pumps.

Outdated technology and poor user interfaces of current infusion systems have led to persistent errors, pump recalls, cybersecurity threats and high costs. Infusion-related errors account for more than 50% of the 1.5 million adverse drug events reported annually to the FDA, and infusion-related adverse drug events account for more than $2 billion in annual healthcare costs.

“For years, I’ve studied smart infusion pump safety and efficiency,” said Karen Giuliano, Ph.D., RN, FAAN, Associate Professor and Executive Director of Healthcare Innovation at Northeastern University Bouvé College of Health Sciences. “My research has focused on revealing the serious usability challenges, which exist in the most commonly used IV smart pumps. Data suggest that the Ivenix Infusion System can enable clinicians to more quickly administer IV medications with significantly fewer errors as compared to today’s leading pumps. Nurses, and the healthcare industry as a whole, have been waiting for an innovative solution like this.”

Ivenix sets a new standard in infusion delivery by rethinking safety, simplicity and interoperability, while providing capabilities not available in any other pump. The Ivenix infusion platform incorporates a patented, adaptive flow control technology, which provides best-in-class flow accuracy and continuity designed to eliminate the risk of free flow. The simple and intuitive user interface makes interoperability easy and aims to reduce alarms. Along with reducing infusion-related errors, Ivenix has the potential to drive down the total cost of ownership by up to 40%.

“We started out knowing that in order to effectively solve today’s medication safety concerns, we needed to build more than a pump,” said George Gray, CTO of Ivenix. “Instead, we built an infusion system that is centered around patients and provides the rich information clinicians need to make safe decisions. In our efforts to make the pump safer, we challenged the status quo and eliminated many of the error-prone tasks that result in preventable adverse drug events. In addition, we examined all the costs associated with owning and operating a pump and found ways to significantly reduce those costs for the hospital. We’re pleased that the FDA cleared our next-generation infusion system. We believe it will dramatically transform the industry.”

The cleared Ivenix Infusion System includes:

A large-volume infusion pump with a smartphone-like user interface, advanced pumping technology that measures flow to maximize accuracy, and a system that is able to anticipate and prevent critical use errors;

A portfolio of administration sets to accommodate the diverse infusion needs of healthcare organizations; and

An infusion management suite of end-to-end administration tools, applications and analytics to remotely monitor infusions and proactively manage improvements.

In addition to meeting the new FDA guidelines, Ivenix has directly addressed the industry’s call to action to improve the safety of pumps set by the ECRI Institute for Safe Medication Practices, and the Association for the Advancement of Medical Instrumentation.

With FDA clearance in place, Ivenix is preparing to bring the Ivenix Infusion System to the U.S. infusion market.

“The demand for a safer, more efficient and more cost-effective infusion system has been overwhelming,” said Susan Niemeier, MHA, RN, CNO at Ivenix. “We’ve had healthcare organizations offer to delay formal product evaluations to ensure Ivenix could be part of the process. The industry is ready for change and we can’t wait to deliver on it.”

Source: Company Press Release