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The SureFlex™ Steerable Guiding Sheath Kit is indicated for introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum.

The SureFlex™ Steerable Guiding Sheath Kit is a single-use device which is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The kit contains a steerable sheath, a dilator, and a guidewire. The steerable sheath is comprised of a stainless steel braided nylon tube with a soft, pebax distal tip. A platinum/iridium marker band is positioned near the distal tip to ensure precise tracking and placement of the sheath during procedures. The sheath is finished at the proximal end with a hemostasis valve and 2.distal side ports with a 3-way stopcock for the injection or aspiration of fluids. The steerable sheath comes in small, medium, and large curve options which can be deflected 90° counter-clockwise and 180° clockwise. The dilator is comprised of an HDPE tube with a tapered tip and has a male luer hub connector at the proximal end for connection to the sheath. The guidewire is stainless steel and coated with PTFE.

The OsteoCool™ RF Ablation System is intended for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body in patients who have failed or are not candidates for standard pain therapy.

The OsteoCool™ RF Ablation System includes the following components: 1. OsteoCool™ RF Ablation Kit consisting of: a. OsteoCool™ Probe b. OsteoCool™ Introducer c. Tube Kit 2. Pain Management Pump Unit & Pump Connector Cable 3. Baylis Pain Management Generator-TD 4. DuoCool™ Connector Cable The OsteoCool™ RF Ablation System is designed to deliver controlled radiofrequency (RF) energy in a bipolar manner with a cooling mechanism. The Baylis Pain Management Generator-TD operates together with the OsteoCool™ Probe to deliver the RF energy. The Pump Connector Cable connects the Pump Unit to the Baylis Pain Management Generator-TD, which powers and controls the pump speed for delivery of cooling fluid during the procedure. The DuoCool™ Connector Cable connects the OsteoCool™ Probe to the Baylis Pain Management Generator-TD to transmit RF current and thermocouple signals to and from the electrodes of the probe. The OsteoCool™ Probe is a single-use device that is inserted through the OsteoCool™ Introducer to the target site. The introducer is used for skin penetration and facilitates the navigation and accurate placement of the probe at the target site. The Tube Kit is used with the Pump Unit to circulate water internally to cool the probe while it delivers RF energy. The OsteoCool™ Probe includes a thermocouple to monitor and control the tissue temperature throughout the procedure.

The TorFlex™ Transseptal Guiding Sheath is used for the percutaneous introduction of various types of cardiovascular catheters to all heart chambers, including the left atrium via transseptal perforation / puncture.

The TorFlex™ Transseptal Guiding Sheath kit consists of three components: a sheath, a dilator, and a J-tipped guidewire. The TorFlex™ Transseptal Guiding Sheath is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The sheath provides superior torque control and is flexible. The radiopaque tip maximizes visualization of the sheath during manipulation. The dilator provides support for the sheath and has a tapered tip.

The InDiscal™ Digital Manometer is indicated to be used for dispensing fluids into the intervertebral disc and monitoring the pressure of those fluids during discography procedures in symptomatic patients with suspected intervertebral disc pathology.

The InDiscal™ Digital Manometer is a sterile, single-use device that is used to dispense fluids into and monitor pressure in vertebral discs during spinal procedures such as discography. The device consists of a plastic syringe with a screw-type plunger and locking lever, a rotating palm grip that controls the plunger, a manometer with a digital LCD screen and a connecting tube.

The DuoCool Pain Management Probe (probe model number: OSP-17-180-20; kit model number: OSK-17-180-20) is intended for use in radiofrequency (RF) heat lesion procedures for relief of pain

The DuoCool Pain Management Probe is a sterile, single-use probe used to deliver Radio-Frequency (RF) energy while being cooled.

The Power Wire Radiofrequency Guidewire is intended to create a channel in totally occluded peripheral vessels 3 mm or greater.

The present device, PowerWire Radiofrequency Guidewire consists of a core wire surrounded with a polymer insulation. The wire connects to a radiofrequency puncture generator at the proximal end via a connector cable, and has an active tip at the distal end to deliver radiofrequency energy. The changes made to the device include changes in active tip geometry and material and addition of more radiopaque bands. The PowerWire Radiofrequency Guidewire is designed to be compatible with most balloon and stent catheters approved for use in peripheral interventional procedures.

The Lev-OR™ Dilation Catheter OTW is used to access discrete regions of the peripheral vasculature. It may be used to facilitate the placement and exchange of guidewires and other interventional devices and may be used for the infusion or delivery of diagnostic and/or therapeutic agents.

The Lev-OR The Dilation Catheters OTW is a family of intravascular catheters each with a shaft designed for use in the peripheral vasculature. The lumen in the catheter permits the use of a guidewire to facilitate advancement of the catheter to and through the lession to be treated. The different models of the Lev-OR™ Dilation Catheter OTW (herein referred to as "Catheter") have varying distal section stiffnesses. The model can be identified by the printed label on the device packaging. The Catheter body low profile and gentle taper facilitate smooth advancement through target locations such as complex lesions. The distal 25cm of the catheter, treated with a lubricious hydrophilic coating, is activated when wet. The Catheter has a radiopaque distal tip and can accommodate a range of 0.014" - 0.035" diameter guidwires depending on the model. A standard female luer connector at the proximal end provides fluid injection capabilities. Depending on the model, the Catheter is intended to be used in conjunction with 0.014" . 0.035" guidewires or Baylis Medical RF PowerWire™ during percutaneous transluminal angioplasty (PTA).

The InDiscal Aspiration Device and Accessories are intended for aspiration of disc material during percutaneous discectomies in the lumbar, thoracic, and cervical regions of the spine.

The InDiscal™ Aspiration Device is a sterile, single-use device that is inserted through the InDiscal™ Aspiration Introducer into the patient to aspirate tissue disc material. The device consists of a handle, coring needle with sheath, storage chamber and activation switch. The InDiscal™ Aspiration accessories include the InDiscal™ Aspiration Introducer, InDiscal™ Aspiration Plug, InDiscal™ Aspiration Cap, InDiscal™ Aspiration Sheath

The Pain Management Optima is intended for use in Radio-Frequency (RF) heat lesion procedures for relief of pain.

The Pain Management Optima is a sterile, single-use cannula with an integrated probe used to deliver Radio-Frequency (RF) energy.

Creation of an atrial septal defect in the heart. Secondary applications include transseptal heart access, monitoring intracardiac pressures, sampling blood, and infusing solutions.

The NRG Transseptal Needle is a sterile, single-use device that delivers radiofrequency (RF) energy to create an atrial septal defect in the heart.