VTT Medical provides groundbreaking outpatient solutions for treating varicose veins associated with chronic venous disorders.
VVT Medical’s open ScleroSafe platform is an advanced non-thermal, non-tumescent technology solution that eliminates the need for surgery or costly capital equipment, while minimizing the pain and recovery time associated with conventional treatment.
With ScleroSafe, VVT Medical has perfected a minimally invasive, tumescent-free approach to simply and quickly eliminate varicose veins and deliver immediate, long-lasting results.
THE DELIVERY SYSTEM
ScleroSafe is a Universal Platform for the treatment of all Chronic Venous Insufficiency (CVI) conditions via non-thermal, non-tumescent endovenous chemical ablation (ECA), or “Sclerotherapy.” The unique delivery system is highly flexible and is designed to deliver any ECA substance – such as the FDA approved Asclera® sclerosant, to treat varicosities, by ablating superficial veins with a diameter of 2 to 5mm (in European), and 2 to 3mm (in the U.S. pending FDA clearance). The patented platform is based on VVT’s combined Inverse Action Dual Syringe and Double Lumen Catheter.
Inverse Action, Dual Syringe
VVT’s unique, inverse action dual syringe (also known as the DPS) injects the ECA substance into the vein through one syringe while simultaneously aspirating blood through the second syringe – all within a single motion and with single-hand operation.
The aspiration of the blood results in negative pressure just behind the injected sclerosant agent. This key feature prevents uncontrolled overspill of the sclerosant upstream, ensures that there is no dilution of sclerosant with blood and minimizes the risk of inflammation. There is minimal pain, no scarring, discoloration or matting, no trapped blood clots, minimal to zero thrombophlebitis and immediate, visible results. VVT’s unique syringe is compatible with both foam and liquid ECA substances.
Double Lumen Catheter
ScleroSafe products feature a range of double lumen catheters with options for different lengths, gauges, levels of stiffness and other mechanical properties to optimize treatment- both at the site and within the blood vessel. All ScleroSafe catheters use a monorail guidewire system and are designed to simultaneously inject the ECA substance from the distal end, while aspirating the blood both in front of and behind the injected substance. They also share the universal compatibility feature of the Inverse Action, Dual Syringe module.
ScleroSafe with V-Block is especially designed to simply, safely and effectively treat severely dilated and challenging Great Saphenous Vein (GSV) conditions, including GSV valve incompetence and Reflux.
While all ScleroSafe products share the Double Lumen Catheter and Inverse Action Dual Syringe design concepts, V-Block products feature a unique embolization device which further enhances the safety and efficacy of treating larger vessels.
Embolization Safety Device
The embolization safety device is designed to block the blood flow within GSVs of larger diameters during ECA/Sclerotherapy procedures. The purpose of the device is to minimize the risk of upflow of the injected substance to the femoral vein and to the upper body. It is a conical, biomedical-grade, flexible nitinol frame covered with a polymer-coated mesh and is tested and approved as a permanent venous implant.
The V-Block device is integrated into the double lumen catheter. It is inserted into the GSV through a micro puncture access point, advanced upward, deployed and then secured 2 cm below the saphenofemoral junction. Its guidance and proper position are verified with ultrasound. Once deployed, VVT’s proprietary Dual Syringe discharges the sclerosant agent into the GSV while aspirating the residual blood, ultimately ablating and closing the faulty vessel. The entire procedure can be completed in less than 7 minutes.
VVT Medical’s Universal Platform for the treatment of all Chronic Venous Insufficiency (CVI) conditions via non-thermal, non-tumescent endovenous chemical ablation (ECA or Sclerotherapy).
ScleroSafe is designed to treat shallow varicosities and visible veins in the legs, including truncal, reticular and sub dermal congested veins. Indicated for: ablation of veins with a diameter of 2 to 5mm (in Europe), and 2 to 3mm (in the U.S., pending FDA clearance).
ScleroSafe can be used with the 5cc\10cc Dual Syringe, a proprietary, specially designed 5F 150mm long or 5F 350mm long double lumen catheter and a dedicated guide wire.
ScleroSafe with V-Block is especially designed to simply, safely and effectively treat severely dilated and challenging Great Saphenous Vein (GSV) conditions, up to 14mm ID.
V-Block is designed to treat challenging GSV conditions, including GSV valve incompetence and Reflux. Indicated for: the occlusion of lower extremity veins with a diameter in the range of 4 to 14mm. Specifically, it is indicated for the occlusion of the Greater Saphenous Vein (GSV) as an adjunct tool for the treatment of venous insufficiency and saphenous reflux disease.
ScleroSafe with V-Block can be used with the 10cc/20cc Dual Syringe, a proprietary, specially designed 6F (450mm) or 6F (650mm) catheter and a dedicated guide wire.