Wearable Vacuum Pump Reduces Seroma Risk

Indicated in a range of surgeries that lead to large surgical flaps that require drains, such as abdominal surgery, mastectomy, plastic surgery, hernia repair, and orthopedic procedures, it is designed to replace the legacy technology of suction bulbs and surgical drains, a solution originally intended for hospital use that can lead to spillage, leakage, and clogging of lines when self-administered.

In addition to its health benefits, the SOMAVAC 100 can be discretely worn under clothing, close to the body, which helps patients return to their normal daily activities while recovering. And while similar in principal to negative pressure wound therapy (NPWT) systems, which apply controlled sub-atmospheric pressure to the local wound environment using a sealed wound dressing connected to a vacuum pump, the SOMAVAC 100 can provide much higher drainage volumes, since NPWT systems are intended for smaller fluid build-up, such as in burns.

“This FDA clearance represents a critical milestone for Somavac Medical Solutions and provides a meaningful advancement in post-surgical care, offering patients the opportunity to recover with dignity at home after major surgeries,” said biomedical engineer Esra Roan, PhD, CEO of Somavac Medical Solutions. “We are excited about receiving our clearance from the FDA for this device so that our technology can begin to improve patients’ recovery after surgeries.”

Seroma is a common postoperative result following ventral hernia repair, with an incidence rate of 20%. Suction using manually operated closed systems has been the mainstay of seroma management for the last 40 years; such devices draw fluid using a compressible suction bulb attached to the end of the drain, which is worn by patients anywhere from days to several months, depending on fluid volume. Inability of the bulb to generate a continuous suction is a major factor in the prolonged drain indwelling times, increasing opportunity for complications.

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