Sapheon Announces One-Year Data in European VenaSeal Stud

Morrisville, N.C.-based Sapheon released one-year data from its European study of the VenaSeal Sapheon Closure System for treatment of venous reflux disease. The system received CE marking in September 2011 and Health Canada approval last month.

Investigators in the single-arm, multicenter postmarket trial observed a 94.3 percent closure rate at six months with no recanalization at one year in the 70 patients followed in the study, the devicemaker said.

VenaSeal uses a minimally invasive catheter to deliver a medical adhesive that closes the saphenous vein in order to halt reflux. This eliminates the need for surgery, thermal ablation, sedation and tumescent anesthesia, the company said. The procedure also avoids the burning or nerve injury that Sapheon says is common in thermal vein closure procedures.

The system is being evaluated in the U.S. under an investigational device exemption. The 1:1 randomized pivotal VeClose study is comparing VenaSeal with radiofrequency thermal ablation in 242 patients across 10 sites. Preliminary results are expected by the second quarter of this year.

Sapheon President and CEO Dan Crawford said plans are to introduce VenaSeal in the U.S. next year. — Lena Freund

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