Creo Medical Group out of Chepstow in South Wales won clearance from the FDA for its Speedboat RS2 device and CROMA platform for endoscopic removal of cancerous and pre-cancerous lesions in the bowel. This was one of the fastest FDA reviews of a 510(k) cleared medical device to date, with the company receiving the answer 49 days following submission of the request. The clearance was so unexpectedly expedient that Creo is now having to adjust its commercialization plans in the U.S. to bring the product to market earlier.
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.
The company believes that the combination of energy deliveries will allow for quicker, more personalized procedures, reduction in instrument exchanges, and more precision during treatment.
Some of the system advantages according to Creo:
* Maintain submucosal lift with integrated injection needle, no instrument changes required
* Bipolar Radiofrequency cutting, for precise lateral and forward dissection
* Microwave coagulation, providing controlled haemostasis
* Protective hull, reducing risk of muscle damage
* Optimised shaft design, enabling controlled rotation