Sapheon has submitted the second module of the pre-market approval (PMA) application to the US Food and Drug Administration (FDA) for VenaSeal sapheon closure system.
The company completed the submission process on December 18, 2013, which represents steady progress on the modular PMA application for VenaSeal.
The VenaSeal sapheon closure system is a minimally invasive, single use kit, designed for the treatment of varicose veins caused by venous reflux disease.
In September 2013, the FDA had reviewed and accepted the company’s first module without deficiencies within a single review cycle.
The safety and effectiveness of the device as against radio frequency thermal ablation is currently being evaluated in a 1:1 randomized pivotal study (the VeClose) at ten US clinical sites.
The VeClose study, authorized under an investigational device exemption (IDE) by the FDA in December 2012, has treated 242 patients and was fully enrolled in September 2013.
The company expects the three-month assessments of patients enrolled in the VeClose study to be completed this month and the study’s primary efficacy end-point of vein closure, as adjudicated by an independent core laboratory, to be reported shortly thereafter.
Earlier in September 2011, the VenaSeal received CE Mark approval in Europe and since then it has been used to treat over 1,700 veins in patients in Europe and Hong Kong.
At this time, the VenaSeal sapheon closure system is limited to investigational use within the US.