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Creo Medical's Speedboat RS2 gains FDA clearance 'ahead of schedule'

by Thomas Dworetzky , Contributing Reporter
Creo Medical Group's Speedboat RS2 device and its CROMA platform received 510(k) clearance, the surgical endoscopic device maker has announced.

Speedboat RS2, powered by the microwave-based CROMA platform, permits “minimally invasive” endoscopic removal of early stage cancerous and precancerous lesions in the bowel.

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This FDA review took just 49 days, and will let the Wales-based company turn its attention to U.S. commercial planning early.

"We continue to execute against our plan and, in this case, come in well ahead of our targets,” said CREO CEO Craig Gulliford, adding that, “this bodes well and provides us with confidence that we have the foundation in place to execute on the suite of devices currently in development."

The approval came almost two quarters ahead of schedule.

"The next step is to roll out the training course that is underway in Europe at the moment and start rolling that into physicians in the U.S.," he told Reuters.

Speedboat RS2 is the first of a number of planned devices that will use the CROMA generator.

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,” the company stated, noting that this is due to its ability to coagulate bleeding vessels with its microwave energy, and to cut or resect with that energy, with minimal risk of puncturing surrounding tissue.

The device has a number of features, including:

  • Its ability to maintain submucosal lift with an integrated injection needle, with no instrument changes required

  • Bipolar radiofrequency cutting for precise lateral and forward dissection

  • Microwave coagulation, providing controlled hemostasis

  • A protective hull, reducing risk of muscle damage

  • An optimized shaft design, enabling controlled rotation

There are now more than 16 million colonoscopies performed annually, and 1.1 million of these find a lesion that needs treatment, of which half are surgically removed.

"Surgical endoscopy is an emerging field and we believe that with the CROMA system, Speedboat and our suite of products, we are well positioned to become a leader in this billion-dollar-plus market," advised Gulliford.

In March, the Speedboat RS2 received its CE Mark approval for microwave energy to add to the device's previously awarded CE Mark for radiofrequency.

Clinical studies had shown it to be safe and efficacious in the application of microwave energy to coagulate bleeds in the colon in 30 patients, according to a report published in Digestive Disease Week at that time.

In 2016, Creo made its stock market debut and raised over $26.5 million from investors. At that time, Gulliford told the Telegraph, “our product enables procedures that are currently only done in the operating theatre to be done in the endoscopy room, so we go from requirement of a general anesthetic to a local one or sedation.”

“It’s using God-given access to a body rather than an incision,” he added, noting, “The other thing that makes this different is that the microwave energy that stops the blood flow can be delivered in a very precise, minimal way."

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