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Increase blood flow from lower extremities in recumbent patients to help prevent deep vein thrombosis (DVT) and pulmonary embolism (PE).

The System 2600 is a three component system consisting of a control unit, inflatable multi-segment leg sleeves, and conduit tubing (4 port) with detachable connections. The control unit is an electro/mechanical device designed to apply a specific degree of pressure to the leg in a precise cycle beginning at the ankle (or lower calf) and continuing sequentially to the thigh. The unit utilizes a software based electronic control system, electro/mechanical compressor, and solenoid operated air inflation control valves. All electrical and mechanical components are contained in a molded plastic housing. Pressure is generated in the control unit and is transferred to the patient by air inflation of the multisegment leg sleeves. The segments are inflated sequentially to various pressure settings to create a decreasing gradient, distal to proximal, on the lower extremity. The inflatable multi-segment leg sleeves are designed to be wrapped comfortably around the patient's leg. They consist of multiple air chambers which can be inflated independently. There are four sizes of sleeves offered for use with the system. Two sizes have all four air chambers positioned between the ankle and knee. The other two sizes position two chambers between the ankle and knee and two chambers above the knee on the thigh. The Jobst System 2600 monitors the sleeve pressure repeatedly during sleeve segment inflation via a pressure transducer. Solenoid activated valves, controlled by the electronic control system, regulate the air pressure in the segment's pressure is controlled by specific solenoid valves and is isolated from the other segments. Segment inflation and cycle timing are based on each segment achieving a preset (non-adjustable) pressure within a maximum allowable time limit. The pressures in each segment are repeatedly monitored and corrected throughout the cycle to ensure the preset pressures are maintained within each segment. After the four segments in the sleeve are inflated in a sequential pressure gradient manner, the solenoid valves open and the air is exhausted. The creation of the gradient sequential condition is dependent on the sequential opening of the solenoid valves and the pressure, monitored by the pressure transducer, in each segment of the sleeve. The pressure setting is fixed and is not user selected.

Increase blood flow from lower extremities in recumbent patients to help prevent deep vein thrombosis (DVT) and pulmonary embolism (PE)

This submission is being made for a sterile version of the sleeve used for the Jobst Athrombic Pump System 2500. This product is a Class II device and is classified as a compressible limb sleeve under 21 CFR 870.5800. The sterile sleeve/Jobst Athrombic Pump System 2500 combination is substantially equivalent to the Kendall Healthcare Product's sterile sleeve/SCD compression system in its mode of operation and indications for use. Both products are used to help prevent deep vein thrombosis and pulmonary embolism in recumbent patients by increasing deep venous blood flow from the lower extremities. This is accomplished by intermittent compression of the muscles in the lower limbs. Both sleeves are made of PVC and are sterilized with ethvlene oxide.

used to help prevent deep vein thrombosis and pulmonary embolism in recumbent patients by increasing deep venous blood flow return from the lower extremittles. This is accomplished by intermittent compression of the muscles in the calf and thigh.

upgrade of the Jobst Athrombic Pump System 2000 to the System 2100. It also covers the use of thigh length sleeves with the System 2100. This device is classified as a compressible limb sleeve under 21 CFR 870.5800.

CVI, edema, lymphedema, phlebitis and vascular malformations.

While Jobst-Custom garments are cut and sewn from fabric made of spandex and nylon varns, the Elvarex garments are flat knit using yarns made of nylon, natural rubber latex, cotton and spandex and then sewn together. Both products use the specific measurements for a patient and calculate the final garment dimensions using the LaPlace formula. Compression is provided for both products by large elastic yarns that act circumferentially on the limb. The gradient compression present with both products helps to force fluid into the deep venous system and in the return of Ivmphatic fluid.