The ULTRA ICE PLUS catheter is indicated for enhanced visualization of cardiac structures and is designed to optimize performance when imaging by enabling users to position the catheter directly adjacent to areas of interest, like the proximal coronary sinus, fossa ovalis, or pulmonary veins. Its 360 degree, forward looking visualization field provides greater near-field resolution than phased array catheters, without the need to manually move the catheter away from a target area to adjust focal distance. 

Know Where You Are

ULTRA ICE PLUS catheter positioned in the right atrium, adjacent to the fossa ovalis, visualizing the structures critical to successful transseptal puncture: the septum, aorta, needle position, tenting, and the LAFW.

See What You Want to Avoid

Notice the patient’s reduced Left Atrium, the tenting of the septum and its relationship to the LAFW. The corresponding fluoroscopic image may suggest that puncture has already occurred. However, the ULTRA ICE PLUS image shows that this is not the case and guides the physician to redirect the needle in a puncture angle away from the LAFW.

Crossing to the Septum to Help Guiding Left Sided Procedures

A key application for the ULTRA ICE PLUS catheter involves crossing the septum and then monitoring and helping to guide left-sided procedures. In this setting, ULTRA ICE PLUS catheter is designed to allow the user to:

• Visualize left atrial anatomy
• Confirm catheter location relative to the anatomy
• Verify tip-to-tissue contact
• Identify location of the esophagus relative to the ablation catheter
• Characterize acute lesion morphology: swelling, dimpling, and crater formation
• Monitor for any early signs of thrombus formation, stenosis, or pericardial effusion

The Ultra ICE Plus Catheter: This rounded tip catheter is indicated for enhanced ultrasonic visualization of intracardiac structures. MDU5 PLUS Sterile Bag: The MDU5 PLUS Sterile Bag is intended to cover the motordrive during intravascular ultrasound procedures to maintain the sterile field and prevent transfer of microorganisms, body fluids and particulate material to the patient and healthcare worker.

CONTRAINDICATIONS

This product is contraindicated in the presence of conditions which create unacceptable risk during catheterization. This device is not intended to be used in the coronary arteries. This device is not intended for fetal use.

WARNINGS

DO NOT advance the catheter if resistance is encountered. The catheter should never be forcibly inserted into lumens narrower than the catheter body or forced through a tight stenosis. If resistance is met upon withdrawal of the catheter, verify resistance using fluoroscopy, then remove the entire system simultaneously. When utilizing a steerable guide sheath, it is not recommended to articulate the sheath tip beyond 55 degrees. Utilizing a fixed curve guide sheath with an angle greater than 55 degrees is not recommended. A guide sheath with an inner diameter less than 2. 84 mm must never be utilized. When utilizing the ICE catheter, it is not recommended to place the transducer assembly within the curve of the guide sheath while imaging.

PRECAUTIONS

Contents supplied STERILE using an e-beam radiation process. Do not use if sterile barrier is damaged. For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. This device should be used by physicians thoroughly trained in the techniques of invasive cardiology and in the specific approach to be used. After the procedure, inspect the catheter carefully for any damage which may have occurred during use. The catheter has no user serviceable parts. Do not attempt to repair or to alter any component of the catheter assembly as provided. Do not attempt to connect the catheter to electronic equipment other than the designated systems. Never attempt to attach or detach the catheter while the motor is running. Throughout the procedure anticoagulant therapy is recommended for patients undergoing left-sided and transseptal cardiac procedures and should be considered for selected patients undergoing right-sided procedures. Avoid any sharp bends, pinching or crushing of the catheter. Do not kink or sharply bend the catheter at any time. An insertion angle greater than 45° is considered excessive. Turn the MDU5 PLUS “OFF” before withdrawing the imaging catheter, or when advancing the catheter in the body. Prior to utilizing the ICE catheter, verify there are not kinks in either the ICE catheter or guide sheath.

The risks and discomforts involved in imaging cardiac structures include those associated with similar types of diagnostic procedures in the heart. However, any of these risks or discomforts may occur with greater frequency or severity than previously reported. Additionally, these complications may necessitate additional medical treatment including surgical intervention. Abnormal heart rhythms, Cardiac wall injury including perforation, Damage to cardiac valvular structures, Death, Endocarditis, Hematoma, Hypotension/Hypertension, Infection/discomfort, Myocardial infarction, Stroke/embolism, Thrombosis, Vascular wall injury including perforation. As with all procedures that utilize the Seldinger Technique for introducing a catheter into an artery, the following complications have been reported: Infection and pain in the region of the insertion site Hemorrhage and Arteriovenous Fistula.