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Medical Devices / Regulatory Affairs / Submissions and Approvals

FDA Clears SinuSys Vent-OS Sinus Dilation System

Jan. 9, 2013

SinuSys plans to launch its Vent-OS two-step osmotic expansion sinus dilation system immediately in certain markets around the U.S., following receipt of FDA 510(k) clearance.

The system, which demonstrated 95 percent patency in a multicenter study, is inserted into the maxillary sinus opening with the device entered vertically and the tip superiorly. The device is then rotated posterior to the uncinate with the tip angled slightly inferiorly, according to the Palo Alto, Calif., company. Once engaged, the device expands by absorbing the moisture from the lining of the passage. After an hour, it can be removed.

SinuSys says the Vent-OS’s small, low-pressure and self-expanding insert opens the maxillary ostia more gently and gradually than balloon technology.

The sinus system is already marketed in the EU, Canada and Australia. — Lena Freund

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