Venclose’s Maven Radiofrequency Ablation Catheter Cleared by FDA to Treat Incompetent Perforator Veins

October 7, 2021—Venclose Inc. announced FDA 510(k) clearance of the Maven endovenous radiofrequency ablation (RFA) catheter for minimally invasive treatment of incompetent perforator veins (IPVs). Venclose has launched the Maven catheter in the United States and is pursuing CE Mark approval for the device in Europe.

According to the company, the next-generation Maven device is designed to close the damaged vein and restore healthy blood flow in patients with venous reflux disease. Like the company's flagship catheter, the Venclose Maven is engineered to facilitate vein wall contact via both segmental and circumferential thermal delivery.

"The Venclose Maven catheter is uniquely designed to expand our options for treating IPVs and associated tributaries," commented Jeff Carr, MD, in the company's announcement. "With the 0.5-cm 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."

Dr. Carr, who is an interventional cardiologist at CardiaStream of Tyler, Texas, also addressed the procedural ease of use with the device, stating, "Delivering treatment is super simple and efficient due to the flexibility, lubricity, and low profile of the device."

Additionally, vascular and interventional radiologist Carlos Hamilton III, MD, of Hamilton Vascular in Sugarland, Texas, compared the procedural advantages of the Maven catheter versus previous method. "It’s a lot smoother procedure with reduced in-vein treatment time. 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."