Motus GI gets FDA nod to expand colonoscopy cleansing system into upper GI endoscopies

FDA
The Pure-Vu system connects to most standard gastroscopes to clear the upper GI tract of blood clots and debris inhibiting visibility during an endoscopy. (Andrew Harnik, Associated Press)

After years of focusing solely on the colon, Motus GI is living up to the full potential of its name by bringing its endoscopy cleansing technology into other areas of the gastrointestinal tract.

With the FDA’s blessing, Motus’ Pure-Vu System can now be connected to gastroscopes in upper GI endoscopy procedures in addition to its previously cleared use in colonoscopies.

The Pure-Vu device slides onto most standard endoscopes and produces pulses of water and air to break up blood, blood clots and other debris in the GI tract that could be blocking endoscopists’ visibility during the procedure.

Clearing the tract while the procedure is in progress also allows physicians to more easily identify the source of and treat any bleeding. Motus GI notes that approximately 400,000 U.S. patients each year experience bleeding in the upper GI tract, a condition that has a mortality rate of up to 10% if left untreated.

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“We believe this regulatory milestone broadens our ability to participate in a larger percentage of procedures performed by our key customers, providing us a natural extension of our commercial strategy,” CEO Tim Moran said in a statement, while describing upper GI bleeds as a largely unmet medical need.

The FDA's 510(k) clearance came well ahead of schedule for Motus GI. When the publicly traded company released its fourth-quarter financial results in March, it announced its intentions to submit the 510(k) application in the third quarter of this year. Instead, Motus submitted the application in early April and was granted the go-ahead in less than a month.

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The Pure-Vu platform was previously cleared for use in colonoscopies in 2016, with the second-generation version of the platform receiving a new clearance in 2019.

For that initial use case, the technology was designed not only to provide a safe and effective cleaning method but also to reduce endoscopists’ reliance on strict patient adherence to pre-colonoscopy protocols. Typically, patients are required to stay on an all-liquid diet for 24 hours beforehand and consume several liters of a bowel-clearing substance; if those instructions aren’t followed to the letter, physicians may have a difficult time navigating the colon during the procedure.

In addition to these two FDA-approved usages, the Pure-Vu platform is now also being tested in patients with lower GI bleeding. A small pilot study began in March and will observe the use of the device in patients undergoing urgent colonoscopy for acute bleeding after receiving little to no bowel preparation.