FDA grants 510(k) approval for Speedboat RS2 device and the CROMA platform to treat bowel lesions.- Creo Medical Group.
Creo Medical Group plc , a medical device company focused on the emerging field of surgical endoscopy, announces that it has received 510(k) clearance from the FDA for its Speedboat RS2 device and the CROMA platform. Speedboat RS2 is the first of a range of medical devices in development, powered by the CROMA platform, and enables the minimally invasive removal of early stage cancerous and pre-cancerous lesions in the bowel through an endoscopic procedure. This FDA Clearance has been received ahead of schedule, with the FDA review process being completed in 49 calendar days from submission. Accordingly, Creo will now assess the necessary steps to bring forward the implementation of its commercial plans for the US.
Speedboat RS2 is the first device developed for use with the Company's generator, CROMA. It harnesses the cut and coagulation capability of CROMA and enables the removal of early stage cancerous and pre-cancerous lesions. The use of Speedboat RS2 reduces the risks associated with incisions which are necessary for laparoscopic procedures and can reduce the length of hospital stay. Endoscopy has been a rapidly expanding practice due to the advent of colorectal cancer screening in most healthcare systems. This has driven growth in equipment and devices to enhance the ability to screen and detect early stage and pre-cancerous lesions in the GI tract.
Comment: Speedboat RS2 device received CE Mark in March 2017.
Comment:The Speedboat RS2 delivers both bipolar radiofrequency (RF) and microwave energy through its tip. The CROMA generator is used to actually energize the Speedboat RS2 device, delivering RF energy to resect and dissect tissue, while supplying microwaves to ablate and coagulate.
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