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The Option™ELITE Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava (IVC) in the following conditions: · Pulmonary thromboembolism when anticoagulants are contraindicated • Failure of anticoagulant therapy in thromboembolic disease · Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced · Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated The Option™ELITE Filter may be removed according to the instructions supplied in the Section IX, entitled "Optional Procedure for Filter Retrieval" in patients who no longer require a filter can only be performed by the jugular approach. The Option™ELITE Vena Cava Filter 100cm System is indicated for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following conditions: · Pulmonary thromboembolism when anticoagulants are contraindicated · Failure of anticoagulant therapy in thromboembolic disease · Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced · Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated The Option™ELITE Filter may be removed according to the instructions supplied in the Section IX, entional Procedure for Filter Retrieval" in patients who no longer require a filter in patients who no longer require a filter. Retrieval of the filter can only be performed by the jugular approach.

The Option™ELITE Vena Cava Filter is designed for the prevention of recurrent pulmonary embolism via percutaneous delivery in the inferior vena cava (IVC). The Option™ELITE Vena Cava Filter 100cm System is designed for IVC filter insertion, delivery, deployment and placement via the popliteal and antecubital approach. The self-centering Option™ELITE Filter is laser cut from nickel - titanium alloy (Nitinol) tubing. The Option™ELITE Filter consists of shape memory Nitinol struts emanating from a central location and is designed for optimal clot capture. Retention anchors (retention hooks) are located at the caudal portion of the filter. These anchors are intended for filter fixation to the vessel wall. The Option™ELITE Filter is intended to be used in caval diameters up to 30mm. A retrieval hook is centrally located at the cranial extremity. The constrained Option™ELITE Filter is flexible and expands to the internal diameter of the IVC upon deployment. The Option™ELITE Filter imparts an outward radial force on the luminal surface of the vena cava to ensure proper positioning and stability. The Option™ ELITE Filter is designed to prevent pulmonary embolism while maintaining caval patency through central filtration. The introduction kit is comprised of a filter housed in a filter cartridge. Catheter Sheath Introducer (5F ID). Angiographic Vessel Dilator with an open end, and a Pusher with deployment marker. The Angiographic Vessel Dilator has side holes and 2 radiopaque markers, separated by 32mm (between the marker bands), that provide linear measurement of the inferior vena cava and assists in angiographic visualization when radiopaque contrast is delivered. The pusher advances the filter through the Catheter Sheath Introducer up to the deployment marker, and is then used to fix the filter in place during uncovering. The location of the distal end of the Catheter Sheath Introducer can be controlled by rotating the entire device to position the Catheter Sheath Introducer in the center of the vena cava. The Filter Cartridge houses the Option™ELITE Filter. The body of the Cartridge has text and colored arrows printed on it that identify assembly orientation, femoral is printed in green and jugular is printed in blue. The arrow of the desired access site will point into the Catheter Sheath Introducer hub. The Angiographic Vessel Dilator is designed to provide angiographic visualization and linear measurement of the vasculature when used in conjunction with the delivery of radiopaque contrast media to the vena cava.

The ALN Optional Vena Cava Filter with Hook and without Hook are indicated for the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations: - Pulmonary thromboembolism when anticoagulants are contraindicated, - Failure of anticoagulant therapy in thromboembolic diseases, - Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced; and - Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated. ALN Optional Vena Cava Filters with Hook and without Hook, may be retrieved with the ALN Extraction and /or Repositioning Kits according to the Instructions For Use of these devices. The ALN Optional Vena Cava Filter with Hook may be also retrieved with a standard GooseNeck Snare according to the the Instructions For Use of this medical device.

The ALN Optional Vena Cava Filter is a conical-shaped structure made of 316LVM stainless steel and consisting of 9 legs (i.e., 9 filtering elements). The 6 shortest legs (i.e., anchoring legs) are ended with distal hooks and each leg has a different length to avoid intertwining when the filter is introduced into the sheath or released in the vessel. The 3 longest legs (i.e., centering legs) have no hooks and serve to line up the vena cava axis. The loop at the end of the longest one helps to push the filter during its implantation through the femoral vascular approach. All 9 legs are equally involved in capturing and breaking an embolus. The ALN Optional Vena Cava Filter is about 55 mm high and is suitable for vena cava diameters up to 32 mm. The implantation approaches may be jugular, brachial or femoral. The ALN Optional Vena Cava Filter with a Hook is the same ALN Optional Vena Cava Filter with an additional 4mm retrieval hook on the apex of the device.

The Denali™ Filter is indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations: -Pulmonary thromboembolism when anticoagulants are contraindicated -Failure of anticoagulant therapy for thromboembolic disease -Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced -Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated. The Denali™ Filter may be removed according to the instructions supplied under the Section labeled: Optional Procedure for Filter Removal.

The Denali™ Vena Cava Filter is a venous interruption device designed to prevent pulmonary embolism. The Denali™ Filter can be delivered via the femoral and jugular/subclavian approaches. A separate delivery system is available for each approach. The Denali™ Filter is designed to act as a permanent filter. When clinically indicated, the Denali™ Filter may be percutaneously removed after implantation according to the instructions provided under the "Optional Procedure for Filter Removal" section in the Instructions for Use. The Denali™ Filter consists of twelve shape-memory laser-cut nickel-titanium appendages. These twelve appendages form two levels of filtration with the legs providing the lower level of filtration and the arms providing the upper level of filtration. The Denali™ Filter is intended to be used in the inferior vena cava (IVC) with a diameter less than or equal to 28mm. The Denali™ Vena Cava Filter System consists of an introducer sheath, an 8 French dilator, and a preloaded Denali™ Filter in a storage tube with a pusher. The 8 French dilator accepts a 0.035" guidewire and allows for an 800 psi maximum pressure contrast power injection. Radiopaque marker bands on the end of the dilator aid in measuring the maximum indicated IVC diameter. They are spaced at a distance of 28mm (outer-to-outer). The 55cm, 8.4 French I.D. introducer sheath contains a radiopaque marker and hemostasis valve with a side port. The pusher advances the filter through the introducer sheath to the predeployment mark and is then used to fix the filter in place while the filter is unsheathed.

The Günther Tulip Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations: - · Pulmonary thromboembolism when anticoagulant therapy is contraindicated; - · Failure of anticoagulant therapv in thromboembolic diseases: - · Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced; and - · Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated. The Günther Tulip Filter implant may be retrieved if clinically indicated; please refer to the "Optional Filter Retrieval" section of the Instructions for Use for more information. The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent PE. The Celect Platinum Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations: - · Pulmonary thromboembolism when anticoaqulant therapy is contraindicated; - · Failure of anticoagulant therapy in thromboembolic diseases; - · Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced: and - · Chronic, recurrent PE where anticoaqulant therapy has failed or is contraindicated. The Celect Platinum Filter implant mav be retrieved if clinically indicated: please refer to the "Optional Filter Retrieval" section of the Instructions for Use for more information. The product is intended for percutaneous placement via a femoral or juqular vein for filtration of inferior vena cava (IVC) blood to prevent PE.

The Celect Platinum Filter Set consists of a filter composed of a paramagnetic cobalt chromium alloy (49 mm long when compressed to a diameter of 30 mm) with platinum markers, preloaded on a femoral filter introducer with a flexible tip; a 7 French coaxial introducer system (compatible with a 0.035 inch wire guide); and a 10 French pre-dilator with hydrophilic coating for vessel access. The introducer dilator has eight sideports and two radiopaque markers 30 mm apart (end-to-end). The Celect Platinum Filter implant is designed to act as a permanent filter or retrievable filter. The Günther Tulip Filter Set consists of a filter composed of a paramagnetic cobalt chromium alloy (50 mm long when compressed to a diameter of 30 mm), preloaded on a femoral filter introducer; a 7 French coaxial introducer system (compatible with a 0.035 inch wire guide); and a 10 French pre-dilator with hydrophilic coating for vessel access. The introducer dilator has eight sideports and two radiopaque markers 30 mm apart (end-to-end). The Günther Tulip Filter implant is designed to act as a permanent filter or retrievable filter.

The Günther Tulip Filter implant is intended for the prevent pulmonary embolism (PE) via placement in the vena cava in the following situations: - · Pulmonary thromboembolism when anticoagulant therapy is contraindicated; - · Failure of anticoagulant therapy in thromboembolic diseases; - · Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced; and - · Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated. The Günther Tulip Filter implant may be retrieved if clinically indicated; please refer to the "Optional Filter Retrieval" section of the Instructions for Use for more information. The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent PE.

The Günther Tulip Filter Set consists of a filter composed of a paramagnetic cobalt chromium alloy (50 mm long when compressed to a diameter of 30 mm), preloaded on a femoral filter introducer; a 7 French coaxial introducer system (compatible with a .035 inch wire guide); and a 10 French predilator with hydrophilic coating for vessel access. The introducer dilator has eight sideports and two radiopaque markers 30 mm apart (end-to-end). The Günther Tulip Filter implant is designed to act as a permanent filter or retrievable filter.

The Cook Celect Platinum Filter implant is intended or the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations: ·Pulmonary thromboembolism when anticoagulant therapy is contraindicated; - · Failure of anticoagulant therapy in thromboembolic diseases; - · Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced; and - · Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated. The Cook Celect Platinum Filter implant may be retrieved if clinically indicated; please refer to the "Optional Filter Retrieval" section of the Instructions for Use for more information. The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent PE.

The Cook Celect Platinum Filter Set consists of a filter composed of a paramagnetic cobalt chromium alloy (49 mm long when compressed to a diameter of 30 mm) with platinum markers, preloaded on a femoral filter introducer with a flexible tip; a 7 French coaxial introducer system (compatible with a .035 inch wire guide); and a 10 French pre-dilator with hydrophilic coating for vessel access. The introducer dilator has eight sideports and two radiopaque markers 30 mm apart (end-to-end). The Cook Celect Platinum Filter implant is designed to act as a permanent filter or retrievable filter.

The Sentry IVC Filter is indicated for the prevention of recurrent pulmonary embolism via percutaneous placement in the inferior vena cava in patients with a transient high risk of PE, in the following situations: · Pulmonary thromboembolism when anticoagulants are contraindicated; · Failure of anticoagulant therapy in thromboembolic diseases; · Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced.

The Sentry IVC Filter is a bioconvertible IVC filter intended for percutaneous implantation in the IVC and designed to provide protection against PE in patients at transient risk of PE. The Sentry IVC Filter is designed for use in inferior vena cavae with diameters between 16mm and 28mm and has a maximum deployed length of 57.7mm. It is preloaded in a Loading Tool that can be orientated for either left/right femoral vein or a right jugular vein approach and is delivered through a 7 French ID Introducer Sheath (max OD 9.75Fr). The Sentry IVC Filter consists of a cylindrical Nitinol frame and a Filter Cone formed by six Filter Arms held together in the center of the IVC by means of a bioabsorbable filament. The Filter Cone is designed to trap emboli and thereby reduce the risk of PE while maintaining caval patency after it has converted. The Sentry IVC Filter converts into a non-filtering configuration, the Filter Cone opens and the arms retract towards the IVC wall. This 510(k) is submitted to support a change to the design and manufacturing process for the Introducer Sheath of the Delivery System.

The Sentry IVC Filter is indicated for the prevention of recurrent pulmonary embolism via percutaneous placement in the inferior vena cava in patients with a transient high risk of PE, in the following situations: · Pulmonary thromboembolism when anticoagulants are contraindicated; · Failure of anticoagulant therapy in thromboembolic diseases; · Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced.

The Sentry IVC Filter is a bioconvertible IVC filter intended for percutaneous implantation in the IVC and designed to provide protection against PE in patients at transient risk of PE. The Sentry IVC Filter is designed for use in inferior vena cavae with diameters between 16mm and 28mm and has a maximum deployed length of 57.7mm. It is preloaded in a Loading Tool that can be orientated for either left/right femoral vein or a right jugular vein approach and is delivered through a 7 French ID Introducer Sheath (max OD 9.75Fr). The Sentry IVC Filter consists of a cylindrical Nitinol frame and a Filter Cone formed by 6 Filter Arms held together in the center of the IVC by means of a bioabsorbable filament. The Filter Cone is designed to trap emboli and thereby reduce the risk of PE while maintaining caval patency after it has converted. The Sentry IVC Filter converts into a non-filtering configuration, the Filter Cone opens and the arms retract towards the IVC wall.

The Günther Tulip Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations: - Pulmonary thromboembolism when anticoagulant therapy is contraindicated; - Failure of anticoagulant therapy in thromboembolic diseases; - Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced; and - Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated. The Günther Tulip Filter implant may be retrieved if clinically indicated; please refer to the "Optional Filter Retrieval" section of the Instructions for Use for more information. The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent PE.

The Günther Tulip Vena Cava Filter is an IVC filter intended for use in prevention of recurrent PE. The filter is intended for percutaneous placement via either the jugular vein or femoral vein for filtration of blood within the IVC. The Günther Tulip Vena Cava Filter Set is available in a Femoral Set and a Jugular Set. Each set consists of a preloaded filter, a coaxial introducer system, a hydrophilic coated pre-dilator, and a three-way stopcock. The filter is introduced and placed via a 7 French coaxial introducer system with a Check-Flo® valve. The introducer dilator has 8 sideports and two radiopaque markers 30 mm apart. The Günther Tulip Vena Cava Filter Set is also available in a universal vein access version consisting of components for both femoral and jugular vein approaches; which includes a preloaded filter in the femoral approach. The Günther Tulip Vena Cava Filter is constructed from a cobalt chromium alloy. The end of each leg is hooked outward; this hook design enables securement of the filter to the wall of the inferior vena cava. "Webbed" wires (like tulip petals) between the legs are bent secondary legs which maintain the shape of the filter by pressing outward the vein walls. These webs also increase the area into which emboli can be trapped. The filter is approximately 50 mm long along its main axis when compressed to a diameter of 30 mm.