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The Advisor HD Grid Mapping Catheter, Sensor Enabled, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.

The Advisor HD Grid Mapping Catheter, Sensor Enabled, is a sterile, singleuse, irrigated, high-density mapping catheter with a 7.5F shaft and an 8F distal shaft deflectable section. It is available in a D-F bi-directional curve model that is deflected using the actuator located on the catheter handle. The catheter working length is 110 cm. The device consists of a paddle-shaped distal tip with 16 electrodes, two distal shaft ring electrodes, two magnetic sensors, polymer braided shaft, handle, fluid lumen extension with a luer, and an electrical connector. The catheter also has an introducer tool intended to compress and guide the distal paddle into, and withdraw from, the hemostasis valve of an introducer sheath. The catheter is compatible with the EnSite Velocity and EnSite Precision Cardiac Mapping Systems and other accessories, including the connecting cable and commercially available irrigation pumps.

The Confirm Rx™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

The St. Jude Medical Confirm Rx™ system consists of the following key features and components: - Confirm RxTM ICM Model DM3500 Implantable Device: The ICM is intended as a minimally invasive, implantable diagnostic monitoring device, with subcutaneous electrodes, looping memory, and automatic as well as patient-activated EGM storage capability, which help physicians monitor, diagnose, and document patients who are susceptible to cardiac arrhythmias. It is predicated on SJM Confirm™ DM2102 with a two-year longevity, MR conditional labeling, and identical sensing and detection algorithms as SJM Confirm™ DM2102, but with downsized hardware and Bluetooth communication. - Implant Tools: Model DM3520 incision tool and Model DM3510 insertion tool to implant the device subcutaneously. - Model 3111 Magnet (existing SJM donut magnet) facilitates faster startup of Bluetooth connection and provides user authentication (required for programmer sessions). - Clinician Programmer (Merlin PCS Programmer Model 3650): The Merlin PCS Programmer 3650 operates using Merlin PCS Model 3330 software and provides the means for the physician to program device parameters and retrieve diagnostic information from the device, including electrograms, heart rate history, episode duration and trend information. - myMerlin™ Patient App (Model APP1000 Android): The Patient App provides the means for the patient to activate EGM recording in the Confirm Rx™ device, with data pass-through functionality to enable physician follow-up via the Merlin.net Patient Care Network. - Remote Care/Clinician Portal (Merlin.net MN5000 Report Generator): The Merlin.net MN5000 system allows physicians to remotely monitor and diagnose patients' cardiac events.

The Nanostim™ Introducer Kit is intended to provide a conduit into the venous system for insertion of diagnostic and other interventional devices.

The St Jude Medical Nanostim Introducer Kit is designed to perform as a guiding sheath for introduction of diagnostic and interventional devices. The Nanostim™ Introducer Kit is comprised of an Introducer sheath and a dilator. The Introducer Kit is compatible with 0.035" and 0.038" guidewires and is available in 18F and one length of 30 cm. The introducer sheath is fitted with a hemostasis valve to prevent blood loss and minimize air introduction during introducer insertion and/or exchange. A sideport with a three-way stopcock is provided for air or blood aspiration and fluid infusion. The introducer features a radiopaque tip marker incorporated within the sheath material to identify the location of the distal tip of the sheath.

The SJM Confirm " ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for other cardiac arrhythmias. The SJM Confirm ICM, Model DM2102, is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

The SJM Confirm ICM is a cardiovascular monitoring device used to record and play back. physiological signals.

The EnligHTN™ Renal Guiding Catheter system is indicated for percutaneous use through an introducer sheath to facilitate a pathway to introduce interventional and diagnostic devices into the renal arterial vasculature.

The EnligHTN Renal Guiding Catheter consists of two primary components, the guiding catheter assembly and the dilator. The guide catheter assembly is the renal access device and has a usable length of 55cm. The outside diameter (OD) of the catheter shaft is 8F (2.7mm) with a distal tip inner diameter (ID) of 0.089 inches. The device is single use and packaged sterile via Ethylene oxide (EO) sterilization. The dilator fits inside the guiding catheter providing support during advancement through the vasculature and placement near the renal ostia. At the proximal end of the guiding catheter is a molded hub equipped with a hemostasis valve that is secured by an ultrasonically welded cap. The hub has a side port feature with an extension tubing and stopcock assembly attached. The distal end of the guiding catheter is formed to match the RDC-1 curve common to the industry and incorporates a radiopaque marker band. The dilator lumen is designed to accommodate a guidewire with an outside diameter of 0.035" or less. The EnligHTN Renal Guiding Catheter system includes the following design aspects: - 55cm Usable Length - Renal double curve (RDC-1) at the distal end to assist in engagement of renal ostium - Radiopaque marker band at the distal tip to aid in visualization under fluoroscopy - Hub with hemostasis valve - Extension tube with 3-way stopcock - Compatible Dilator

The 6F Proxis System controls the flow of fluids in the coronary and peripheral vasculature. This is achieved by temporary vessel occlusion to hold a column of fluid in the vessel stagnant. The stagnant column can be used to aid in the visualization of the lesion or be used as a means of local and temporary delivery of therapeutic solutions. The 6F Proxis System is also indicated for use as an aid in the removal of fresh, soft emboli and thrombi in the coronary and peripheral vasculature. The safety and efficacy of this device as an embolic protection system has not been established. The 6F Proxis System is not indicated for use for embolic protection. The device is not intended to be used as a thrombectomy system.

The 6F Proxis System (Proxis System) is a proximal flow control system used in conjunction with other interventional devices. The Proxis System controls the flow of fluids in the coronary and peripheral vasculature. This is achieved by temporarily occluding the vessel which holds the column of fluid stagnant. The stagnant column can be used to aid in the visualization of the lesion and for the delivery of therapeutic solution(s). The Proxis System consists of an Evacuation Sheath Catheter (Proxis Catheter), inflation device. aspiration syringe, lip seal, and strainer basket. In addition, an optional accessory called the Proxis Infusion Catheter (packaged separately) may be used with Proxis System. The Proxis Catheter is loaded onto the guide wire and tracked down to the distal portion of the guide catheter and proximal to the lesion. When the sealing balloon is inflated, antegrade flow of the fluid in the target vessel is prevented. While the vessel is occluded, therapeutic solutions may be infused through the Proxis Catheter and stagnated in the target vessel/lesion during the delivery of the therapeutic device or after the deployment of the therapeutic device. The aspiration syringe is provided for the removal of stagnated fluid and/or fresh, soft thrombi and emboli during aspiration. Additionally, if there is insufficient venous or collateral flow, the Proxis Infusion Catheter (optional accessory) may be used to infuse saline to augment the retrograde flow of fluid and removal of stagnated fluid.

The EnSite System is indicated for patients for whom electrophysiology studies are indicated. When used with the EnSite* Catheter, the EnSite System is intended to be used in . the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone. OR When used with the EnSite NavX™ Surface Electrode Kit, the EnSite System is . intended to display the position of conventional electrophysiology catheters in the heart.

The EnSite System is a computerized storage and display system for use in electrophysiology studies of the human heart. The system consists of a console workstation, patient interface unit, and an electrophysiology mapping catheter or surface electrode kit.

The SJM™ Rigid Saddle ring is indicated for use to correct annular dilation, increase leaflet coaptation, and prevent further dilatation of the mitral valve annulus caused by diseased states such as degenerative disease, rheumatic disease, Ischemia or vascular disease. The combination of prosthetic ring with valvuloplasty may be used in all acquired or congenital mitral insufficiencies with dilation and deformation of the fibrous mitral annulus. For mitral insufficiencies with no subvalvular lesions and normal valvular movements, r of that ring implant alone may be sufficient. However, annuloplasty ring implant along with mitral valvuloplasty repair must be considered for insufficiencies with a prolapsed while mark relongation or rupture of the chordae tendineae and for insufficiencies with valve ado to blongation ements due to fusion of the commissures or chordae tendineae, or chordal hypertrophy.

The SJM™ Rigid Saddle Ring assembly consists of a rigid core machined from titanium covered with a double velour polyester fabric with a sewing cuff created for suturability. The ring is mounted on a holder and placed in a dual barrier package system. The package system is then steam sterilized. The SJM™ Rigid Saddle Ring is available in sizes 24mm-34mm (even sizes). Sizing is based on the inter-commissural distance as indicated by the commissure markers placed on the ring.

The SJM® Tailor™ annuloplasty band is indicated for use in the repair of a mitral or tricuspid valve that is diseased or damaged due to acquired or congenital processes.

The Tailor band is a flexible band fabricated with a medical grade silicone rubber core, surrounded by polyester fabric.

The SJM® Tailor™ annuloplasty ring is indicated for use in the repair of a mitral or tricuspid valve that is diseased or damaged due to acquired or congenital processes.

The Tailor ring is a flexible ring fabricated with a medical grade silicone rubber core, surrounded by polyester fabric. The full ring may be cut to form a partial or "C" ring.