An Australian medical device maker that has a cleared device to detect lymphedema struck a national purchasing agreement with the U.S. Oncology Network. The Texas-based group has more than 1,200 physicians across 470 locations, and is a subsidiary of McKesson Corporation.
Lymphedema is a condition characterized by swelling in the arms and legs. It can be a side effect of some cancer treatments that affect the lymphatic system, such as chemotherapy, radiation, and surgical removal of the lymph nodes. In its early stages, the condition can be easily treated, but in its later stages, it can’t be completely reversed.
ImpediMed’s device, SOZO, resembles a scale. The bioimpedance spectroscopy device measures fluid status and tissue composition, and can be used to detect lymphedema early by detecting an increase in a patient’s extracellular fluid. The Brisbane-based company received FDA 510(k) clearance in 2018 to use the device to help physicians detect lymphedema,
The most common way of diagnosing it has been to use a measuring tape to detect swelling. ImpediMed CEO Rick Carreon said the device could detect fluid changes as small as 2.5 tablespoons, long before a change is visible.
Dr. Loren Rourke, chief surgical officer for the U.S. Oncology Network, said it would use the device as part of its cancer survivorship program. One of its locations, Texas Oncology, will purchase 17 units.
“This adds tremendous value to our patients, and we expect to see further expansion of SOZO in our network in the months ahead,” she said in a news release.
Carreon said the device has been in the market for about two years.
“We’re expecting this to be a major opportunity for us,” he said. “We’ve really started to see a significant growth for our device, specifically for lymphedema in the U.S.”
The company has also received FDA clearance to use its device for other indications, including monitoring patients with heart failure for fluid management problems. Carreon expects to release the new software that could help risk-stratify patients in Australia next month, and in the U.S. later.
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