FDA grants clearance for ivWatch Model 400 monitoring device

12 April 2015 (Last Updated April 12th, 2015 18:30)

US-based medical device maker ivWatch has received clearance from US Food and Drug Administration (FDA) for its first-of-its-kind continuous monitoring device, ivWatch Model 400.

US-based medical device maker ivWatch has received clearance from US Food and Drug Administration (FDA) for its first-of-its-kind continuous monitoring device, ivWatch Model 400.

The device is expected to improve patient care by quickly detecting common adverse events such as intravenous (IV) infiltration and extravasation.

Infiltrations are leaks of less-harmful infusates that can cause pain, redness of the skin and swelling, while extravasations are leaks of potentially harmful infusates such as chemotherapy medications.

The company said peripheral IV therapy is a common part of many hospital visits, but it can often result in adverse events that, until now, were accepted as the norm.

Each year, more than 150 million peripheral IVs are placed in the US. In the country, more than 80% of hospital patients receive peripheral IVs and 30% of these fail due to infiltrations and extravasations that occur when IV fluids, called infusates, inadvertently enter surrounding tissue.

"The device is expected to improve patient care by quickly detecting common adverse events such as intravenous (IV) infiltration and extravasation."

Existing and most widely used methods for detecting these problems are visual and tactile examinations of IV sites by nurses, typically every one to four hours.

The company said the new ivWatch sensor technology will be a significant advancement in patient safety. It is expected to help clinicians in the early detection of both types of events.

The ivWatch sensor technology uses an optical sensor coupled with a patient monitor, in which the sensor illuminates tissue near the IV site with visible and near infrared light, and the light returning from the tissue is processed by the patient monitor using a proprietary algorithm.

The company said caregivers are notified if conditions suggest that an infiltration or extravasation has occurred.

ivWatch president Gary Warren said: "It's very rare that one gets an opportunity to be involved in something that can have such a large impact affecting so many people.

"IVs are probably the most common medical procedure performed and 30% of them fail, often as a result of infiltration. It's a huge problem.

"Others have tried to solve it, but we are the first to develop the technology and bring a practical and cost-effective solution to market."