U.S. FDA clears Venclose Maven to treat incompetent perforator veins
Equipment

U.S. FDA clears Venclose Maven to treat incompetent perforator veins

Next-generation radiofrequency catheter offers first thermal ablation perforator treatment advancement in over 10 years

  • By IPP Bureau | October 07, 2021

Venclose, a privately-held Silicon Valley medical device company focused on innovative treatment procedures for venous reflux disease announced FDA 510(k) clearance for Venclose Maven, a novel radiofrequency ablation (RFA) catheter for minimally invasive treatment of incompetent perforator veins (IPVs). The Venclose Maven catheter represents Venclose's commitment to developing next-generation venous treatment solutions that help physicians provide more comprehensive patient care

"While our existing Venclose RF Ablation System, including the proprietary Venclose Catheter, continues to displace older technology for treating incompetent truncal veins, Venclose Maven will now allow doctors to also address refluxing perforators, a separate category of veins that contributes to more advanced and serious venous disease symptoms including painful venous stasis leg ulcers," said Jerry Gibson, Venclose Chairman and CEO.

Like Venclose's flagship catheter, the Venclose Maven is engineered to facilitate vein wall contact via both segmental and circumferential thermal delivery. These performance features were applied with the knowledge that physicians already familiar with this ablation method could quickly and easily incorporate the Venclose Maven catheter into their practices for IPV treatment.

According to Jeff Carr MD, FACC, board-certified Interventional Cardiologist with CardiaStream of Tyler, TX, "The Venclose Maven catheter is uniquely designed to expand our options for treating IPVs and associated tributaries. With the 0.5cm length treatment coil and 20-second treatment cycles, I have more confidence in applying a uniform therapeutic effect to the vein. This is a significant improvement over the existing RF device for IPVs."

Venclose is shipping the Maven catheter to U.S. vein practices as it pursues CE Mark approval for delivery to its expanding EU markets.  

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