venaseal

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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 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 reported shortly afterwards."

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.