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For the introduction of various types of pacing or defibrillator leads and catheters.

The Thomas Medical Products, Inc. (TMP) Coronary Sinus Guide & Lateral Vein Introducer Kits (CSG/LVI) are intended to access the coronary venous system. either alone or in a telescopic assembly with other introducers. The CSG/LVI Introducers serve as a conduit to quide devices, including guidewires, pacemaker or defibrillator leads, and catheters, or to deliver contrast medium into specific branches of the coronary venous system. CSG/LVI introducers are intended to introduce left ventricular leads through their lumen. They have direct contact to the inner heart. CSG/LVI introducers come with various curve configurations and lengths to facilitate access to the coronary sinus OS and sub-selective access to angulated lateral vein branches. CSG/LVI introducers are designed as single use devices and for short term application (< 24 hours). Only medical doctors and medical personnel, who are well trained in cardiology, should apply these introducers. The Coronary Sinus Guide Introducer has a peel-away sheath with break-away hemostasis valve. The Lateral Vein Introducer has a break-away hub with integrated handle that requires no cutting and provides a secure grip during slicing, reducing, reducing the risk of lead displacement. The Lateral Vein Introducers have a shaft design with three (3) gradually decreasing stiffness segmentations from proximal to distal. The shaft is reinforced by a metal broid from the proximal end until approximately 0.175 inch from the distal end. The shaft is coated by a medical-grade coating that provides enhanced lubricity when advanced through the Coronary Sinus Guide Introducer. The proximal end of the CSG/LVI Introducers are equipped with a hemostasis valve that reduces the risk of blood loss and air embolism and a side-port with 3-way stopcock to allow fluid infusion and contrast injection. There are differing various versions of the introducer curves that are used according to the anatomy of the present coronary vasculature. The distal soft tip has a tapered outer diometer and the distal tip further contains a polymeric x-roy marker for enhanced visibility under fluoroscopy. Package contents (Coronary Sinus Guide Introducer Kit): - One (1) Coronary Sinus Guide Introducer - One (1) P.T.F.E. coated guidewire - One (1) Curved braided guiding core or non-braided guiding core - One (1) Straight vessel dilator - One (1) Transvalvular Insertion Tool (T.V.I.) - One (1) 18 g XTW needle - One (1) 12 cc syringe Package contents (Lateral Vein Introducer Kit): - One (1) Lateral Vein Introducer - One (1) Transvalvular Insertion Tool (T.V.I.) - One (1) Slicer - One (1) Target Vein Selector Merit Impress Radiology Catheter, k053171

ScoutPro Inner Catheters are indicated for the delivery of contrast media or Biotronik devices into the left ventricular coronary venous system. ScoutPro Inner Catheters are not intended to introduce left ventricular leads through their lumen.

The Thomas Medical Products, Inc. (TMP) ScoutPro Inner Catheters are intended to access the coronary venous system, either alone or in a telescopic assembly with other introducers. The guide catheters serve as a conduit to guide devices, including guidewires, or to deliver contrast medium into specific branches of the coronary venous system. ScoutPro Inner Catheters are not intended to introduce left ventricular leads through their lumen. They have direct contact to the inner heart. ScoutPro Inner Catheters come with a 50° to 90° tip angle. They are designed as single use devices and for short term application (< 24 hours). Only medical doctors and medical personnel, who are well trained in cardiology, should apply these catheters. The ScoutPro Inner Catheters are designed for guiding devices, including guidewires, with an outer diameter smaller than 1.1 mm. In addition, the ScoutPro Inner Catheters can work with outer catheters. The ScoutPro Inner Catheters are compatible with the following devices: - ScoutPro Guidewire @ 0.035" (BIOTRONIK #359805) - - ScoutPro hemostatic valve (BIOTRONIK #345779) - - Various ScoutPro 7F catheter shapes (Extended Hook Right BIOTRONIK#35937, Extended Hook -#350369, Straight #359371, MPEP #359373, BIO2 #359374, Amplatz 6.0 #350235, Hook #350236, Multipurpose Hook #350237, Extended Hook Right L #361531, Extended Hook L 3361530, Straight L #361536, MPEP L #361533, BIO2 L #361529, Amplatz 6.0 L #361527, Hook L #361532, Multipurpose Hook L #361534) - Commercially available Guide Wires (0.014" 0.035") - - Commercially available medical devices with male Luer-Lock (stopcocks, syringes) 1 - -Commercially available fluid x-ray diagnostic contrast media. The ScoutPro Inner Catheters have a shaft design with four (4) gradually decreasing stiffness segmentations from proximal to distal. The shaft is reinforced by a metal braid from the proximal end until approximately 32 mm from the distal end. The shaft is coated by a medical-grade coating that provides enhanced lubricity when advanced through an outer catheter or in the coronary vasculature. The proximal end is equipped with a hub that has a female luer lock connector for adapting a syringe or a three way stopcock with luer lock connections. , There are differing versions in the curve form, 50° to 90° curve at the distal end, that is used according to the anatomy of the present coronary vasculature. The distal soft tip has a tapered outer diameter and the distal tip further contains a platinum/iridium marker ring for enhanced x-ray visibility. Package contents: - One (1) guide catheter - One (1) 3-way stopcock - One (1) Instructions for use manual.

The CSI is indicated for use in arterial and venous procedures requiring percutaneous introduction of therapeutic or diagnostic intravascular devices or fluids.

The RCIS consists of a 5-7F spiral reinforced sheath introducer and an appropriately sized dilator packaged in a tyvek/polymylar pouch. Each reinforced introducer sheath features an integrated hemostasis valve system with a sideport extension and a 3-way stopcock. Each introducer also has a radiopaque distal tip to aid the physician is correct placement of the device. The RCIS dilator is lockable to the mating reinforced introducer sheath. The dilator has a straight curve configuration that extends approximately 2.5cm beyond the matching sheath when the dilator is locked to the sheath. The dilator is compatible with an up to 0.038" diameter guidewire.

The [Reinforced Catheter Introducer System]* is indicated for use in arterial and venous procedures requiring percutaneous introduction of therapeutic or diagnostic intravascular devices.

The RCIS consists of a spiral reinforced sheath introducer and an appropriately sized dilator packaged in a tyvek/polymylar pouch. Each reinforced introducer sheath features an integrated hemostasis valve system with a sideport extension and a 3-way stopcock. Fach introducer also has a radiopaque distal tip to aid the physician is correct placement of the device. The RCIS dilator is lockable to the mating reinforced introducer sheath. The dilator has a straight curve configuration that extends approximately 2.5cm beyond the matching sheath when the dilator is locked to the sheath. The dilator is compatible with an up to 0.038" diameter guidewire.

The Y-Glide™ Hemostatic Wye Adapter is to be used for maintaining a hemostatic seal around inserted devices with an outside diameter up to 0.120" (3.04 mm) during the use of diagnostic/interventional devices for transluminal procedures.

The Thomas Medical Products Inc. Y-Glide™ Hemostatic Valve Wye Adapter contains a hemostasis valve with a secondary locking seal, a rotating luer lock, and a sideport. The primary hemostasis seal is opened by depressing the cap thereby enabling valve flushing, and a conduit for introduction and withdrawal of diagnostic/interventional devices. When the cap is not depressed, the seal returns to the closed position to allow device positioning with minimal fluid loss. The secondary locking seal can be adjusted when the internal threads are engaged, by rotating the cap clockwise while slightly depressing it until the threads catch. Clockwise turns of the cap thereafter will close the locking seal. Rotating counterclockwise will open the locking seal. Closing the locking seal will secure the position of the inserted diagnostic/interventional device and/or permit pressure injections up to 450 psi (30.6 Atm.).

For the introduction of various types of pacing or defibrillator leads and catheters. AND For the introduction of various types of catheters.

The Thomas Medical Products Inc. Large bore splittable introducer kit(s) consists of a splittable sheath introducer and appropriately sized vessel dilator. A hemostasis valve is incorporated at the proximal end of the sheath. The valve reduces blood loss through the sheath during the catheter / lead introduction. The 'splittable' function allows for removal of the sheath from the vascular system over the inserted catheter or lead and then removal the sheath from the lead by splitting the device along its' longitudinal axis. The sheath is available packaged (1) sterile with an appropriately sized dilator, (2) sterile as a procedural convenience kit with an 18 gage XTW needle, guidewire, and 12 cc syringe, and (3) bulk non-sterile.

For the percutaneous introduction of various types of cardiovascular catheters to all heart chambers, including the left atrium via transseptal perforation / puncture.

The Thomas Medical Products Inc. Braided Guiding Introducer System(s) are designed t to provide a conduit to deliver diagnostic and therapeutic catheters to specific heart chambers and locations in the heart. The sheath may be used for percutaneous entry. Each Braided Guiding Introducer System consists of the following: a sheath, a dilator, and a "J" tip guidewire. In addition, a standard 12 cc syringe, a 18 gage XTW introducer needle, and a pre-dilator may also be packaged with the Braided Guiding Introducer System.

Used to create the primary puncture in the interatrial septum when passing an introducer and/or catheter through the septum from the right side of the heart to the left side.

The Thomas Medical Transseptal Needle consists of a specifically curved distal portion to accommodate positioning in the cardiac anatomy when used in conjunction with a transseptal introducer. A stopcock is attached to the proximal end of the needle for air aspiration, fluid infusion, blood sampling and pressure monitoring. A pointer is included on the needle shield to show orientation of the curve.

For the introduction of various types of cardiovascular catheters into the left side of the heart through the interatrial septum.

The Thomas Medical Products Inc. modified Transseptal Introducer Sets are designed to provide a conduit to deliver diagnostic and therapeutic catheters into the left side of the heart through the interatrial septum. Each modified Transseptal Introducer Set consists of; a sheath, a dilator, and a "J" tip guidewire. In addition, a standard 12 cc syringe, a 18 gage XTW introducer needle, and a pre-dilator may also be packaged with the Transseptal Introducer Sets as optional accessories.