Pacing leads and delivery systems

SelectSite™ deflectable catheter system

<p>The SelectSite™ deflectable catheter Model C304 is a steerable system for lead delivery at or near the bundle of His.</p>

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Indications, Safety, and WarningsIndications (or Intended Use)The device is indicated to provide a pathway through which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart and for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.ContraindicationsUse of the device is contraindicated for patients with obstructed or inadequate vasculature and for right ventricular use in patients with tricuspid valvular disease or a mechanical tricuspid heart valve.Warnings and Precautions

The device is for single use only and is not intended to be resterilized.

Use the deflectable catheter only with compatible transvenous devices. No test data is available to demonstrate compatibility of the deflectable catheter with any device not manufactured by Medtronic. For the C304 Catheters, no test data is available to demonstrate compatibility of the transvenous devices with an outer diameter larger than 1.5mm (4.6Fr), with the exception of the 1.85mm (5.6Fr) dilator included with the device package. Consequences of using the deflectable catheter with incompatible devices may include the inability to deliver the transvenous device or damage to the transvenous device during delivery.

Thrombogenicity evaluations were conducted using a heparinized model. If your patient cannot be adequately anticoagulated, it is unknown whether thrombus formation may occur with this product.

Handle the deflectable catheter with care at all times. Do not kink, stretch, or severely bend the deflectable catheter. Do not use surgical instruments to grasp the deflectable catheter. Avoid contact with liquids other than isopropyl alcohol, blood, saline, or contrast solution.

Use the valve to impede the back flow of venous blood during the implant procedure. Ensure that the flush port stopcock is closed before attaching the valve to the deflectable catheter hub.

Keep external defibrillation and backup pacing readily available during implant. Use of the device, transvenous devices, or both may cause heart block.

Potential Adverse Events or Potential ComplicationsPotential adverse events related to the use of the deflectable catheter may include, but are not limited to, the following events: air embolism, allergic reaction to contrast media, arteriovenous fistula formation, bleeding at the insertion site, brachial plexus injury, cardiac tamponade, dislodgement, dissection, endocarditis, heart block, hematoma formation, hemothorax, infection, irregular heart beat, mediastinal widening, perforation, pneumothorax, subclavian artery puncture, thrombophlebitis, thrombosis, valve damage, vascular occlusion, vessel damage.See the device instructions for use for detailed information regarding the procedural instructions, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult the Medtronic website at www.medtronic.com.Caution: Federal law (United States) restricts these devices to sale by or on the order of a physician.MAJ_83037

Features

Improved reach and enhanced range

Adjustable curve is designed to reach a large variety of patient anatomies^† and accommodate challenging anatomical situations, including a large right atrium^‡
Achieves various curve shapes during implant using only this steerable guide catheter
Handle mechanism secures a desired shape, reducing the need to physically hold the curve in place during the procedure

Stable and supportive

Rigid proximal portion provides mechanical support and stability for lead delivery and fixation, while the softer distal end minimizes tissue injury
Catheter deflection is designed to push tip toward the targeted tissue and maintain stability on the septum
Catheter provides a stable workspace to pass guidewires and leads in the cardiac venous anatomy
Dual-braided lumen provides stability^§

Increased implant success

C304-HIS catheter design allows the tip to achieve an angle closer to perpendicular in the region of the His-bundle for a higher fixation rate versus the C315-HIS catheter^†,‡
C304-HIS catheter may be used in conjunction with the Medtronic Model 3830 pacing lead
Catheter body is radiopaque for visibility on fluoroscopy and has improved visualization of the catheter (versus C304-L69 catheter) with an additional marker at the distal end

Maneuverability

Handle mechanism enables tip deflection by transmitting fine movements to the catheter shaft, allowing placement at the bundle of His
Designed for improved manipulation^◊ — deflect for gross movement and torque for minor movement
Braided, kink-resistant catheter design with multiple transition zones allows for various stiffness characteristics, providing flexibility to navigate curvatures of venous anatomy

Ordering information

Item number	C304-HIS
Primary curve shape	Deflectable and preshaped
Secondary curve: Out-of-plane, His-shape curve	Yes, preshaped
Introducer	9 Fr
Usable length	43 cm
Inner diameter	5.7 Fr
Outer diameter	8.4 Fr
Integrated valve	No
Manipulation	Articulation handle
Hydrophilic coating	No
Shelf life	2 years
Marker band material	2 gold band markers
ETO sterilization	Yes

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† Using modeling study of 20 different patient anatomies, selected to include patients with atria ranging from 38–197 mL RA volumes.

‡ Across tested anatomies, the C304-HIS catheter improved fixation success rate in larger RAs with volumes between 110 mL and 139 mL (versus C315 catheter).

§ Within the wall thickness of the device lumen is a second braided lumen for the pull wire.

◊ In comparison to C315-HIS catheter.

SelectSite™ deflectable catheter system

Features

Improved reach and enhanced range

Stable and supportive

Increased implant success

Maneuverability

Ordering information

Similar products

United States

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