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The Bridge Plus Occlusion Balloon catheter is is indicated for temporary vessel occlusion of the Superior Vena Cava (SVC) and Inferior Vena Cava (SVC) in applications including perioperative occlusion and emergency control of hemorrhage.

The Bridge Plus Occlusion Balloon is designed to be delivered percutaneously to the superior vena cava (SVC) or the inferior vena cava (IVC) for the purpose of providing occlusion, emergency control of hemorrhage and perioperative occlusion in the event of an SVC or IVC tear or perforation during a vascular procedure. The Bridge Plus Occlusion Balloon catheter is constructed of a compliant polyurethane balloon mounted on a 12Fr dual lumen nylon shaft. This guidewire lumen is used to pass the catheter over a guidewire. The balloon has a length of 80mm and inflation diameter ranging from 20-29mm. Three platinum-iridium radiopaque markers are placed within the balloon segment of the catheter to provide visual reference points for balloon positioning within the SVC or IVC prior to inflation.

The preCARDIA device is intended for use in selectively stopping or controlling blood flow of the inferior and superior vena cava in applications including perioperative procedures in patients requiring emergency control of hemorrhage, and for blood pressure monitoring.

The preCARDIA System is for use in selectively stopping or controlling blood flow of the inferior and superior vena cava, in applications including perioperative procedures in patients requiring emergency control of hemorrhage, and for blood pressure monitoring. The System includes a Balloon Occlusion Catheter (Catheter), Controller and Console. The Catheter has an atraumatic endovascular balloon that has been attached to the proximal portion of a commercially available Thermodilution (TD) Catheter. The single use, 110 cm disposable catheter comes in two balloon locations, 34 and 36 cm measured from the distal end of the catheter and is provided sterile. The catheter placement procedure is performed under fluoroscopy by clinicians trained in endovascular techniques. The balloon includes proximal and distal radiopaque markers to allow for visualization and confirmation of proper placement in the IVC or SVC. Following placement and securement of the catheter, the patient can be transferred to the operating room or other appropriate care location where selectively stopping or controlling blood flow in the SVC or IVC will continue alongside other standard of care treatments. The primary operating principle of the preCARDIA System is the selective stopping or controlling of the blood flow in the IVC or SVC through either sustained inflation or successive inflation and deflation cycles of the balloon as regulated by the Controller.

The LANDMARK REBOA Catheter is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.

The LANDMARK REBOA Catheter is a 67cm, 59cm working length, 6.5 Fr (2.2mm), single lumen balloon catheter for temporary intravascular vessel occlusion in patients requiring emergency control of hemorrhage. Radio-opaque markers are provided on the catheter shaft at the proximal and distal ends of the balloon for radiological location of the device is additionally provided with depth markings referenced from the balloon to provide positioning information similar to the predicate device prior to confirmation of placement through radiological means. The device is intended to be deployed through a 7F introducer sheath placed into the femoral artery through normal vascular access procedures. The LANDMARK REBOA Catheter consists of five elements: - . Occluder Balloon Inflation Lumen with female luer (DEHP free PVC) - Catheter Handle (PA 12) - Catheter Shaft (polyimide and stainless steel) with Marker Bands (stainless steel) - Occluder Balloon (polyurethane) - Guide J-tip (stainless steel, nitinol, acrylic) ●

The Fogarty Occlusion Catheters are indicated for temporary vessel occlusion. The Large Occlusion Catheters are intended to be used for temporary occlusion in the aorta, vena cava and internal jugular vein. The Small Occlusion Catheters are intended to be used for temporary occlusion in the peripheral vascular system.

Models: 620403F, 620404F, and 620405F The Fogarty Small Occlusion Catheters (4F, 5F) consist of a single-lumen polyvinylchloride catheter body with a latex balloon at the distal end and a gate valve at the proximal end. The 3F Fogarty Occlusion Catheter is made of Nylon. The catheter lumen is used for inflation of the balloon via a syringe connected to the gate valve. A removable stainless-steel stylet is provided with each catheter to maintain the straight catheter shape and to ensure that the lumen remains opened during storage of the product. Models: 62080814F and 62080822F The Fogarty 8F Large Occlusion Catheters consist of a single-lumen polyvinylchloride catheter body with a latex balloon at the distal end and a gate valve at the proximal end. The catheter lumen is used for inflation of the balloon via a syringe connected to the gate valve. A removable stainless-steel stylet is provided with each catheter.

The RenovoCath is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapentic agents, to selected sites in the peripheral vascular system. The RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. The RenovoCath is intended for general intravascular use in the peripheral vasculature in arteries 3mm and larger. The RenovoCath is intended for use in arteries from 3mm in diameter for vessel entry and to occlude vesses ranging between 3mm to 11mm in diameter. The diagnostic and/or therapents are to be used in accordance with specifications outlined by the respective agent manufacturer.

The RenovoCath is a multi-lumen, dual-balloon catheter with a two-part handle that is designed for targeted delivery of fluids, including radiopaque material and therapeutic agents, to selected sites in the peripheral vascular system. The distance between the proximal and distal balloons is adjustable. The effective length is 75cm to 85cm (adjustable). Radiopaque markers are located between the balloons to allow for identification of targeted site and position adjustment under fluoroscopic guidance. The RenovoCath is intended to be used with 6 Fr guide sheaths and 7 Fr guide catheters and is compatible with 0.014" guidewires.

The AortaSTAT Occulsion Device is indicated for temporary vessel occlusion in the suprarenal and infrarenal aorta in applications for perioperative occlusion and emergency control of hemorrhage

The RenalPro Medical AortaSTAT Occlusion device allows continued distal perfusion of the aorta while occluding the entrance into the target side branch arteries. The RenalPro Medical AortaSTAT Occlusion Device is comprised of a polymeric thin film membrane covering a self-expanding Nitinol scaffold connected to a stainless-steel central lumen, contained within a stainlesssteel braid-reinforced, Pebax outer shaft lined with PTFE for lubricity. The outer shaft and central lumen are attached to a deployment handle. The AortaSTAT Occlusion Device is provided sterile and non- pyrogenic and is for single patient use only. The AortaSTAT device is delivered to the targeted vasculature location under fluoroscopy using standard endovascular techniques over a commercially available 0.018″ Guidewire. Once the device is positioned, the covered scaffold is deployed by actuating the handle to slide the outer shaft back, allowing the scaffold to expand and providing radial occlusion of the target vessel. The AortaSTAT has a radiopaque marker near the distal ends of the nitinol scaffold, and another marker encapsulated at the distal end of the outer shaft to enable visualization under fluoroscopy. The AortaSTAT device is 8 Fr compatible in four diameters of occluding scaffolds: 19mm, 22mm, 25mm, and 28mm. The device has a 55 ± 5mm occlusive length and a 65cm working length.

The Neurescue device is intended for temporary occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of hemorrhage.

The NEURESCUE device is a large vessel occlusion catheter comprised of two main components: The NEURESCUE Catheter and the NEURESCUE Assistant. The Catheter is an occlusion balloon catheter and the Assistant is a hub for interfacing with the operation of the Catheter. During normal use the device can be operated automatically. Alternatively, the device can be operated manually. For manual use the interface consists of two Luer lock ports for: - Manual inflation and deflation of the balloon with saline - - -Flushing of the arterial FLUSH port with saline Inflation and deflation of the balloon can be accomplished by an automatic filling and deflation function (automatic operation with a peristaltic pump) or manually. Whether the filling is performed manually or automatically, the user is informed of the pressure at the tip of the Catheter. The device has a built-in alarms system.

The COBRA-OS™ is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.

The COBRA-OS™ is a large vessel occlusion device and includes a 4 French Custom Sheath Introducer Kit and a 10 cc syringe. The occlusion device consists of a stiff inner guidewire with an atraumatic floppy distal J-tip that is housed in a compliant occlusion balloon with proximal and distal necks. The inner guidewire provides adequate stiffness. No other guidewires are required. The proximal neck of the balloon is connected to an overmolded hub and stopcock for balloon inflation and deflation. Suture tabs on the overmolded hub are used to secure the device to the patient's skin with sutures. A J-tip straightener is included and preloaded on the distal neck to facilitate the introduction of the device into the 4 French introducer sheath hemostasis valve. Pad printing marks on the outer occlusion device shaft indicate distance to the desired location.

The Bridge Occlusion Balloon catheter is indicated for use for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage. Any use for procedures other than those indicated in the instructions is not recommended.

The Bridge Occlusion Balloon catheter is designed to be delivered percutaneously to the superior vena cava (SVC) for the purpose of providing occlusion of the SVC and providing emergency control of hemorrhage and perioperative occlusion in the event of an SVC tear or perforation during a lead extraction procedure. The Bridge Occlusion Balloon catheter is constructed of a compliant polyurethane balloon mounted on a dual lumen polyurethane shaft. The hub port, marked BALLOON, is connected to the balloon inflation lumen. The unmarked hub port is connected to the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire. A strain relief is mounted to the catheter shaft just distal of the proximal hub. Three platinum-iridium radiopaque markers are placed within the balloon segment of the catheter to provide visual reference points for balloon positioning within the SVC prior to inflation.

The pREBOA-PRO™ Catheter is intended for temporary occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of hemorrhage.

The pREBOA-PRO™ Catheter is a large vessel occlusion catheter with a dedicated lumen for pressure monitoring. The device consists of a semi-compliant balloon, in-line pressure relief valve (safety valve), atraumatic distal tip (P-tip™), dual lumen catheter shaft and a hub with extension lines to provide access to each lumen. The pREBOA-PRO™ Catheter balloon is designed with flow channels to enable the clinician precise, smooth control during inflation and deflation. Instructions for how to titrate the balloon for partial occlusion, if so desired by the clinician, are included in the Instructions for Use. The device has an effective length of 72 cm and is compatible with 7 Fr introducer sheaths as shown in the compatibility section of the IFU. The catheter has a unibody design and is intended to be placed and advanced without a quidewire. In addition, the catheter is compatible with guidewires up to 0.025" that can be used to facilitate subsequent vascular procedures affer a REBOA procedure. A peel-away sheath is preloaded on the catheter shaft covering the balloon to ease insertion of the catheter's P-tip™ into an introducer sheath hemostasis valve. A catheter shaft provides appropriate stiffness with a distal tip (P-tip™) designed for atraumatic advancement of the catheter in a blood vessel. Pad printed marks on both sides of the outer catheter shaft indicate distance to the center of the balloon as well as average insertion depth ranges to the center of aortic Zones 1 and 3 to facilitate proper placement. Radiopaque platinum iridium marker bands are located at the functional ends of the balloon to facilitate and visualize accurate balloon placement when used with imaging. The proximal end of the catheter has a hub and extension lines. The arterial line lumen is used to monitor blood pressure above the balloon. The balloon lumen is used to inflate and deflate the balloon as needed. An in-line Pressure Relief (safety) Valve is connected to the balloon lumen stopcock and is designed to help prevent over-inflation of the balloon. The stopcocks provide control to each of the catheter's two lumens. The peel-away sheath can be separated from the catheter shaft affer insertion if needed. The device is a single-use, sterile device.