Resitu Medical, has received FDA 510(k) clearance to market its RESL09 device for the process of obtaining breast tissue for the diagnostic analysis of imaged abnormalities.
RESL09 is a handheld, minimally invasive, vacuum assisted, and single use device capable of excising large samples of breast tissue with a diameter up to 9mm for diagnostic purposes.
The device is guided by ultrasound, and the surgeon introduces the device through a small incision in the skin of the breast. The device is advanced through the tissue with blunt dissection, until the tip of the instrument is just in front of the lesion. The sample capture relies on a combination of vacuum fixation followed by cutting with a circular knife. To excise the sample, the device uses an electrosurgical cutting electrode. The instrument - with the sample inside the tube - is withdrawn and the lesion is sent for histopathological analysis.
Resitu, in collaboration with dedicated distributors, is pursuing a limited launch for RESL09 in select geographies in the US, Europe (post CE mark), and the United Arab Emirates (post approval and registration).
Following this, Resitu continues with regulatory submission and anticipates a global launch of the RESL device.
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