Health Canada approves Sapheon’s VenaSeal sapheon closure system

29 January 2014 (Last Updated January 29th, 2014 01:00)

US-based Sapheon has obtained Health Canada approval for its VenaSeal sapheon closure system, designed to treat venous reflux disease (varicose veins).

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US-based Sapheon has obtained Health Canada approval for its VenaSeal sapheon closure system, designed to treat venous reflux disease (varicose veins).

By using a specially formulated medical adhesive, the VenaSeal system closes the saphenous vein.

In addition, the system avoids the need for surgery, thermal ablation, sedatives, and tumescent anaesthesia.

In Canada, Dr Joel Gagnon and Dr David Liu in Vancouver and Dr David Szalay and Dr Ted Rapanos in Toronto have performed the first VenaSeal cases.

So far, nine patients have been successfully treated with 100% vein closure and no tumescent anesthesia or post treatment compressions stockings were used.

Sapheon Canada sales manager Nate Raabe said: "We have seen excellent clinical results in patients throughout Europe and look forward to expanding VenaSeal's availability in Canada."

"The recent discovery of a polyoma virus that is associated with MCC supports the potential for an immunotherapeutic approach."

In the US, the VenaSeal sapheon closure system is currently under clinical investigation in the VeClose study. The randomised pivotal study is designed to assess the safety and effectiveness of VenaSeal system compared with radiofrequency thermal ablation.

The VeClose study, authorised under an US Food and Drug Administration-approved investigational device exemption (IDE), has clinical investigators at ten sites in the US for the treatment of 242 study patients. The study was fully enrolled in September 2013.

Since receiving CE Mark approval in September 2011, the VenaSeal sapheon closure system has been used to treat over 1,700 veins in patients in Europe and Hong Kong without tumescent anesthesia or post-procedure compression hose therapy.

The VenaSeal sapheon closure system is yet not commercially available in the US.


Image: Sapheon's VenaSeal uses a specially formulated medical adhesive to close the saphenous vein. Photo: courtesy of Businesswire/Sapheon Inc.