AROA says that based on the results from a study underway in New Zealand, its Enivo system is showing promise in the management of ‘dead space’ after mastectomy.
It said that six patients had undergone unilateral mastectomy surgery and had the device implanted. Ten participants are expected to be enrolled in the study.
’Dead space’ refers to the open space created by surgical separation or excision of soft tissue, which can lead to secondary complications, such as seromas and haematomas, resulting in complications and extending hospital stay for patients.
AROA said its Enivo system applies vacuum pressure to a surgical site to eliminate surgical dead space and reduce fluid accumulation following surgery.
CEO Brian Ward said, “The results emerging from the Enivo study are very encouraging. We have now treated six patients and overall, we are very pleased with the way the device has functioned, with no breast seromas forming. We are hopeful that Enivo could pave the way for a new standard of care in a wide range of surgeries where managing dead space is difficult and subsequent complications may lead to poor outcomes for patients and higher treatment costs.”
A seroma is a collection of fluid that builds up and can result in infection, discomfort, poor cosmetic outcomes, and extended hospital stay. Seromas are the most common post-operative complication to develop following mastectomy. Currently, surgeons use surgical drains, adhesives, or quilting sutures to manage dead space and prevent fluid accumulation.
Associate Professor Michelle Locke, who is leading the study, added, ”I am delighted to be involved in the Enivo clinical study, and hopeful that this innovation will make a real difference to patient outcomes.”