US-based 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, designed for the treatment of varicose veins caused by venous reflux disease.
The company completed the submission process on 18 December 2013, which represents steady progress on the modular PMA application for VenaSeal.
The VenaSeal sapheon closure system is a minimally invasive, single-use kit for the treatment of venous reflux (varicose veins) disease.
In September 2013, the FDA 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 randomised pivotal study (the VeClose) at ten US clinical sites.
The VeClose study, authorised 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 afterwards.
Sapheon is also sponsoring a 70-patient European post-market evaluation study that completed enrolment in September 2012 and a 38-patient feasibility study conducted in the Dominican Republic, which completed enrolment in July 2011.
The company has agreed to continue to follow the patients in these two studies for a period of three years and plans to use the clinical data collected in these studies to support the PMA application, as well as reimbursement in markets outside the US.
In September 2011, the VenaSeal received CE Mark approval in Europe and since then it has been used to treat more than 1,700 veins in patients in Europe and Hong Kong.
The VenaSeal sapheon closure system is currently limited to investigational use within the US.
Sapheon also announced full subscription to its $10m bridge convertible note financing. The offering was introduced at the October 2013 OCTANe Medical Device & Investor Forum, and was fully subscribed within six weeks as a result of strong interest by the company's existing investors.
Sapheon president and CEO Don Crawford said 2013 was an exciting year for the company.
"In 2014, the focus for our team is on preparations for a 2015 US product launch and eventual market leadership in the treatment of venous reflux disease," Crawford said.
Image: The VenaSeal sapheon closure system. Photo: courtesy of Business Wire/ Sapheon Inc.