The Sinopsys Lacrimal Stent for Lacrimal System Repair in Epiphora

The Sinopsys Lacrimal Stent Used During the Repair of the Lacrimal System in Patients With Epiphora

Prospective, open label, multi-center, non-randomized study designed to collect initial clinical data related to the safety and clinical performance of the Sinopsys Lacrimal Stent for use during repair of the lacrimal system in patients with functional or obstructive epiphora.

Up to 10 patients will be enrolled and followed for six months. The primary objective is to demonstrate the safety and clinical performance of the Sinopsys Lacrimal Stent for use during repair of the lacrimal system for ethmoid sinus intubation and bypass to canalicular pathologies in this patient population. The primary outcome measure for performance is the relief of epiphora determined by both investigator assessment of stent patency and patient self-assessment of epiphora symptom improvement compared to baseline.

Inclusion Criteria:

• Clinically significant functional epiphora for at least three months
• Keros classification 1 or 2 skull base anatomy

Exclusion Criteria:

• Active infection
• Craniofacial deformity
• Severe inflammatory disease