Venclose recently announced US Food and Drug Administration (FDA) 510(k) clearance for Venclose Maven, a novel radiofrequency (RF) ablation catheter for minimally invasive treatment of incompetent perforator veins.
“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 incompetent perforator vein treatment, a press release explains.
According to Jeff Carr, board-certified interventional cardiologist with CardiaStream (Tyler, USA), “The Venclose Maven catheter is uniquely designed to expand our options for treating incompetent perforator veins 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.” Carr also spoke to the procedural ease of use by adding, “Delivering treatment is super simple and efficient due to the flexibility, lubricity and low profile of the device.”
Board-certified vascular and interventional radiology physician Carlos Hamilton III of Hamilton Vascular (Sugarland, USA) similarly experienced the procedural advantage of the Venclose Maven catheter compared to the decade-old legacy method. “It is a much smoother procedure with reduced in-vein treatment time.” Hamilton added, “The Venclose Maven is a lot easier to work with and seems much better tolerated by my patients. And the higher temperature allows for a much faster procedure.”
Venclose is shipping the Maven catheter to US vein practices as it pursues CE mark approval for delivery to its expanding EU markets.