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The Venclose System (Venclose digiRF Generator with EVSRF Catheter) is intended for endovascular coaqulation of blood vessels in patients with superficial vein reflux. The Venclose Maven System (digiRF Generator and Maven Catheter) is intended for endovascular coagulation of blood vessels in patients with perforator and tributary vein reflux.

The Venclose™ digiRF Generator is a multi-voltage energy delivery system with touchscreen control that automatically sets the non-adjustable treatment parameters for the catheter to be used with the generator (time, temperature, etc.), which is connected via a triaxial catheter connector port. The Venclose™ digiRF Generator is intended to be used with Venclose™ RF Catheter(s) (either the Venclose™ EVSRF Catheter or the Venclose™ Maven Catheter) as a system. The Venclose™ RF System uses resistive radiofrequency ablation via energy delivery to heat the wall of an incompetent vein with temperature-controlled RF energy to cause irreversible luminal occlusion, followed by fibrosis and ultimately resorption of the vein.

The Venclose Maven System (digiRF Generator and Maven Catheter) is intended for endovascular coagulation of blood vessels in patients with perforator and tributary vein reflux.

Venclose Maven System consists of two (2) main components: - 1) Maven Catheter with integrated cable connector and, - digiRF Generator which delivers radiofrequency (RF) energy to the Maven catheter. 2) The Maven catheter is a sterile single-use disposable medical device for endovenous radiofrequency ablation. The primary components of the catheter include the shaft, handle and integrated connector cable. The catheter shaft is 6 French (6F = 2.0 mm in diameter) in profile, with an insertable length of 40 cm and a 0.5 cm heating coil. The catheter is energized by the digiRF Generator which is a multi-voltage energy delivery system with touchscreen control that automatically sets the non-adjustable treatment parameters for the catheter. The Venclose Maven System (digiRF Generator and Maven Catheter) uses resistive radiofrequency ablation (via energy delivered to heat the wall of an incompetent vein) with temperature-controlled RF energy, and an already widely accepted procedure to cause irreversible luminal occlusion. This is followed by fibrosis and ultimately resorption of the vein. The Venclose Maven System (digiRF Generator and Maven Catheter) supports an optional foot pedal.

The Venclose™ Radiofrequency System (Generator and Catheters) is intended for use in endovascular coagulation of blood vessels in patients with superficial vein reflux.

The Venclose RF System is composed of two basic components: an energy console or generator (digiRF) and catheters (EVSRF) designed specifically to be used with the generator. The Venclose RF System uses resistive radiofrequency ablation via energy delivery to heat the wall of an incompetent vein with temperature-controlled RF energy to cause irreversible luminal occlusion, followed by fibrosis and ultimately resorption of the vein. The blood then naturally reroutes to healthy veins. The technique involves percutaneous access and insertion of the EVSRF Catheter into the great saphenous vein (GSV) or other superficial vein under ultrasound guidance, injection of local anesthesia, and thermal energy from a radiofrequency generator (digiRF) applied into the target vein. As the EVSRF Catheter is withdrawn stepwise down the treated length of the vein, thermal damage is inflicted upon the venous endothelium and through the vein wall, resulting in contraction and ultimately destruction of the vessel. The procedure can be performed in an outpatient setting, without the need for general anesthesia, allowing for a walkin/walk-out procedure with minimal postoperative recovery time.