The FDA has cleared Creo Medical Group to start selling its Speedboat RS2 device in the U.S. Creo designed the device to enable the minimally invasive removal of lesions from the bowel.
Surgeons can use Speedboat RS2 with Creo’s Croma generator to perform endoscopic submucosal dissection (ESD). The Speedboat RS2 instrument delivers radiofrequency energy for dissection and resection and microwave energy for ablation and coagulation. Creo thinks these features and other cut the risk of puncturing tissue, making the device a safer way to remove precancerous and early-stage cancerous lesions.
The claims are backed by data suggesting Speedboat RS2 is free from the bleeding and perforation issues that led groups such as U.K. cost watchdog NICE to give ESD a tepid reception.
In a 31-patient clinical trial, Speedboat RS2 resected complex colorectal polyps. The polypectomy sites of 97% of patients healed within three to six months. One patient was lost to follow up. The device also coagulated 50 of the 51 bleeds without causing adverse events.
The FDA 510(k) nod clears Creo to start making its pitch to the surgeons that perform the 15 million or so colonoscopies carried out in the U.S. every year.
“Over the coming weeks, we will be looking to bring forward the development of our U.S. capabilities whilst continuing with the promising training programme underway in Europe,” Creo CEO Craig Gulliford said in a statement.
The need to pull forward the U.S. strategy reflects the swift review of Speedboat RS2 by the FDA. At 49 days, the review time for the device is toward the bottom of the range for electrosurgical and endoscopic devices cleared over the past year. The FDA took marginally less time, 46 days, to clear a product from Wilson-Cook Medical. But other devices cleared with the same product code, KNS, over the past year all took significantly longer to get nods from the FDA.
Picking up the fast approval means Creo has secured regulatory nods on both sides of the Atlantic in its first year as a public company. Creo listed in London late last year, adding about $26 million in public funding to the $21 million it raised as a private enterprise.