SyntheMed: FDA Clearance for SinusShield

SyntheMed, of Iselin, NJ, has received FDA 510(k) clearance for SinusShield, a bioresorbable membrane to prevent post-operative adhesions from forming after nasal and sinus surgeries.

It’s common for surgeons to place silastic tubes or sheets in the sinus passages to prevent blockage caused by scar tissue. However, these materials must often be removed during a second procedure. SinusShield is intended to prevent blockage and then biodegrade.

SyntheMed is now in talks with prospective distribution partners who would service the office-based and hospital outpatient sites where these surgeries are performed. There are approximately two million nasal and sinus procedures performed annually in the U.S.

“SinusShield represents an example of our strategy to capitalize on our proprietary polymer film technology in new surgical applications both in the United States and international markets,” said Robert Hickey, SyntheMed’s President and CEO.

Previously: SyntheMed Raises $4 Million

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