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CEDTB400L
Instructions for Use
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Medtronic CEDTB400L Instructions for Use

DiamondTemp™
Ablation Catheter
Instructions for Use
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Medtronic, Medtronic with rising man logo, and Medtronic logo are trademarks of Medtronic. Third-party trademarks (“TM*”) belong to their respective owners. The following list includes trademarks or registered trademarks of a Medtronic entity in the United States and/or in other countries.
DiamondTemp™

Contents

3

1 Glossary of symbols

The following table defines symbols that are used on packaging and product labeling. Refer to the labels to determine which symbols apply to this product and for the product-specific information, such as the date of manufacture.
Symbol
Standard/Standard Title or Reference
21 CFR 801.109
a
Symbol title/Reference number Explanatory Text
Prescription only USA Federal law restricts
this device to sale by or on the order of a licensed healthcare practitioner.
ISO 15223-1
b
Consult instructions for use (clause 5.4.3)
Consult instructions for use at this website: www.medtronic.com/man­uals
ISO 15223-1
b
Catalog number (clause 5.1.6)
Indicates the manufactur­er’s catalog number so the device can be identified
ISO 15223-1
b
Batch code (clause 5.1.5)
Indicates the manufactur­er’s batch code so that the batch or lot can be identified
ISO 15223-1
b
Use by date (clause 5.1.4)
Indicates the date after which the device is not to be used
ISO 15223-1
N/A Manufactured in/ manufac-
ISO 15223-1
b
Manufacturer (clause 5.1.1)
Indicates the medical device manufacturer
Indicates where the device
turing site
b
Date of manufacture (clause 5.1.3)
was manufactured
Indicates the date when the medical device was manu­factured
ISO 15223-1
b
Keep Dry (clause 5.3.4)
Indicates a medical device that needs to be protected from moisture
ISO 15223-1
b
Do not use if package is damaged (clause 5.2.8)
Indicates a medical device that should not be used if the package has been dam­aged or opened
ISO 15223-1
b
Caution (clause 5.4.4)
Indicates there is important cautionary information for the medical device.
ISO 15223-1
b
Do not re-use (clause 5.4.2)
Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure
ISO 15223-1
ISO 15223-1
ISO 15223-1
ISO 15223-1
b
b
b
b
Do not resterilize (clause 5.2.6)
Sterilized using ethylene oxide (clause 5.2.3)
Non-pyrogenic (clause 5.6.3)
Keep away from sunlight (clause 5.3.2)
Indicates a medical device that is not to be resterilized
Indicates a medical device that has been sterilized using ethylene oxide
Indicates a medical device that is non-pyrogenic.
Indicates a device that needs protection from light sources.
N/A Storage temperature limit Indicates the required tem-
perature range for storing the device
N/A Transit temperature limit Indicates the required tem-
perature range for trans­porting the device
N/A Package contents Indicates the components
included in the device pack­age
4
Symbol
Standard/Standard Title or Reference
Symbol title/Reference number Explanatory Text
N/A Unidirectional catheter Indicates that a unidirec-
tional catheter is included in the device package
N/A Bidirectional catheter Indicates that a bidirec-
tional catheter is included in the device package
ISO 7000
c
Product documentation (symbol 0419)
Indicates that product doc­umentation is included in the device package
N/A Unidirectional Indicates a catheter that
operates only in one direc­tion
N/A Bidirectional Indicates a catheter that
operates in two directions
ISO 15223-1
b
Sterile barrier (clause 5.2.13)
Single sterile barrier system with protective packaging inside
a
21 CFR 801.109: United States Code of Federal Regulations, Title 21, Food and Drugs
b
ISO 15223-1: Medical devices – Symbols to be used with medical device labels, labeling and information to be supplied
c
ISO 7000: Graphical symbols for use on equipment

2 Device description

The Medtronic DiamondTemp ablation catheter is a sterile, single use, externally irrigated ablation catheter designed to deliver radiofrequency (RF) energy for cardiac ablation. It is designed to be used in conjunction with the DiamondTemp generator, DiamondTemp catheter-to-RFG cable, DiamondTemp GenConnect cable, DiamondTemp EGM cable, DiamondTemp irrigation pump, and DiamondTemp tubing set.
The DiamondTemp ablation catheter is available as unidirectional (Figure 1) or bidirectional (Figure 2) with a distal electrode segment and a proximal handle that are connected by a torquable shaft. The unidirectional catheter has an actuation piston to actuate the curve in one direction. The bidirectional catheter has a steering knob to actuate the curve in either direction and a tension knob to lock the curve. (Refer to Table 1 for model information.) The distal tip and ring electrodes of the catheter are designed to record intracardiac electrocardiogram (ECG) signals for mapping and stimulus delivery. RF energy delivery by catheter tip-to-tissue contact is similar to other commercially available, externally irrigated catheters. Refer to the catheter package labeling for electrode spacing details.

Table 1. Catheter models and specifications

Description Specification
Catheter shaft size (outer diameter) 2.67 mm (8 Fr) Catheter ablation tip size (tip electrode) 2.50 mm (7.5 Fr) Length 110 cm (43.3 in) Compatible sheath 2.83 mm (8.5 Fr) Model CEDT100S Unidirectional, small curve (45 mm) Model CEDT200L Unidirectional, large curve (63 mm) Model CEDTB300S Bidirectional, small curve (45 mm) Model CEDTB400L Bidirectional, large curve (63 mm)
The catheter is constructed of thermoplastic elastomer materials and noble metal electrodes. Thermocouples are incorporated at the distal and proximal end of the tip electrode for temperature sensing during RF ablation. The highest temperature from all thermocouples is displayed on the generator. The generator modulates the delivered RF energy to maintain tissue temperature at a user-defined temperature set-point.
The catheter, when connected to the tubing set and irrigation pump, delivers normal saline (0.9%) with Heparin at 1 IU mL via a lumen in the catheter. Saline is delivered to the tissue and through 6 ports located on the catheter tip. The saline cools the catheter tip and tip-tissue interface. One luer connection at the proximal end of the handle connects to the tubing set, allowing the irrigation pump to generate the flow of normal saline to the catheter.
5

Figure 1. DiamondTemp Ablation Catheter (unidirectional)

1 Catheter shaft 2 Shaft strain relief 3 Actuation knob

Figure 2. DiamondTemp Ablation Catheter (bidirectional)

1 Catheter shaft 2 Strain relief 3 Steering knob
4 Handle 5 Cooling lumen
4 Tension knob 5 Cooling lumen

3 Indications for use

The DiamondTemp catheter is indicated for use in cardiac electrophysiological mapping (stimulation and recording) and for treatment of drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation when used in conjunction with the DiamondTemp RF generator and accessories (DiamondTemp catheter-to-RF generator cable, DiamondTemp GenConnect cable, DiamondTemp EGM cable, DiamondTemp irrigation pump, DiamondTemp irrigation tubing set) and compatible mapping system.

4 Contraindications

• Patients with active systemic infection
• Patients with prosthetic valves
• Patients with intracardiac thrombus or myxoma, or interatrial baffle or patch via transseptal approach
• Patients unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation
• Pregnant women and children <18 years of age
• Patients who are hemodynamically unstable

5 Warnings and precautions

• Before use, inspect the catheter for any foreign particles or material, defects, or physical damage, including electrical insulation of the cable. If the catheter is defective or damaged, do not use and contact a Medtronic representative. Replace damaged devices or equipment as necessary.
• Carefully read all DiamondTemp ablation system (catheter, generator, catheter-to-RFG cable, GenConnect cable, EGM cable, irrigation pump, tubing set) instructions before use. Observe all contraindications, warnings, and precautions noted in the directions. Failure to do so may result in patient complications.
• If the DiamondTemp system is used in conjunction with a compatible mapping system (such as the Abbott EnSite™ Velocity™ or Precision™ Mapping System), consult the respective instructions to ensure correct connectivity and usage. Construct an anatomic map of the region of interest only after all mapping catheters and electrodes, the DiamondTemp catheter, respective cables, and neutral electrodes (including the ablation return pad) are completely and properly connected. The subsequent addition of catheters or electrodes may render the anatomic map inaccurate and require remapping.
• Carefully read the instructions for all ancillary devices or products used in the procedure before use.
• The catheter is for single use only. Do not reprocess or resterilize. Reusing, reprocessing, or resterilizing may compromise the structural integrity of the device or lead to product failure, which may result in patient injury, illness, or death. Reuse, reprocessing, or resterilizing may also create a risk of contamination of the device. Contamination may lead to injury, illness, or death of the patient.
• Use the catheter before the “Use by” date on the device package.
• Cardiac ablation procedures should be performed only by physicians trained in the techniques of RF catheter ablation in a fully equipped electrophysiology (EP) laboratory.
• Pacemakers and implantable cardioverter defibrillators (ICDs) can be adversely affected by RF signals and appropriate precautions should be taken before, during, and after ablation to minimize risk.
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• Implantable devices such as ICDs should be deactivated or programmed to the OFF mode before ablation. Perform complete ICD system analysis on all patients after ablation.
• Use careful catheter manipulation and awareness when in close proximity to atrial or ventricular leads.
• Anticoagulation therapy is required before device introduction to prevent thrombus formation.
• Catheter ablation procedures present a risk of significant x-ray exposure, which can result in acute radiation injury as well as increased risk for somatic and genetic effects to both patients and laboratory staff. Catheter ablation should only be performed after adequate attention has been given to the potential exposure associated with the procedure and steps taken to minimize this exposure.
• Long-term risks of RF ablation lesions have not been established.
• To avoid risk of injury, do not ablate near the phrenic nerve.
• Ablation too close to the esophageal area can result in esophageal fistula.
• Use caution when placing lesions in the proximity of the cardiac conduction system.
• Ablation near the AV node can cause permanent or partial conduction block.
• Ablation within and in close proximity to the coronary arterial vasculature has been associated with myocardial infarction and death.
• Catheter materials are not compatible with magnetic resonance imaging (MRI).
• In accordance with hospital protocol, monitor the patient’s fluid balance throughout the procedure to avoid fluid overload.
• Catheter entrapment within the heart or blood vessels is a possible complication of EP procedures.
• Do not use excessive force when inserting, advancing, or removing the catheter.
• Before insertion into the patient, flush the catheter by pressing the Purge Flow button on the irrigation pump, at a flow rate of 60 mL/min, and ensure there are no air bubbles.
• To ensure proper operation of the tissue contact impedance measurement function, all 4 electrodes and 6 thermocouples on the catheter tip must protrude from the distal tip of the sheath.
• Ablation over other catheter electrodes (on a diagnostic catheter, for example) has been associated with unintended EGM noise.
• Carefully monitor the tissue contact impedance before delivery of RF energy. Do not place the RF electrode in proximity to any other mapping or ablation electrodes, as this may cause inadvertent, ineffective, or unsafe tissue ablation and may increase chances of char, coagulum, or steam pops.
• If the contact impedance reads less than 35 Ω, the generator will not allow delivery of RF energy. In such circumstances, replace the catheter. If after replacing the catheter the condition persists, replace the catheter-to-RFG cable and the GenConnect cable (if used). If the condition still persists, power down the generator and contact a Medtronic representative.
• Although a high contact impedance value typically indicates acceptable tissue contact, and low contact impedance values typically indicate lack of tissue contact, caution should be exercised. Areas of previously ablated tissue may display a low contact impedance value. Other parameters, such as EGM, fluoroscopic images, and intracardiac ultrasound should be monitored before deciding to apply RF.
• Do not deliver RF energy if the catheter is outside the target site. The RF generator can deliver significant electrical energy and may cause patient injury.
• Use caution during multiple sheath and catheter exchanges through the transseptal puncture. Caution is necessary to avoid causing a residual atrial septal defect that would require repair.
• The transseptal procedure presents the potential risk for an air embolus, which may involve the coronary arteries. Aspiration and flushing of the sheath, dilator, and needle should be performed during insertion or exchange, to minimize this risk. Refer to the individual sheath, dilator, and needle instructions.
• Fibrin may accumulate in or on the sheath and catheter assembly during the procedure. Aspirate when removing the dilator or catheter. Follow the sheath instructions for maintaining sheath patency during use.
• Stimulation of cardiac tissues caused by pacing stimulus or RF energy may lead to inadvertent induction of arrhythmias. These arrhythmias may require defibrillation that could also result in skin burns.
• Do not use the catheter for epicardial ablation.
• Using ablation parameters (such as temperature set-point, ablation duration, or irrigation flow rate) other than those recommended by Medtronic may be hazardous to patients. Exercise caution and sound medical reasoning when deciding to deviate from recommended parameters.
• Delivery of RF energy may result in neuromuscular stimulation. Monitor patient reactions.
• The power, temperature, and impedance display of the generator should be continuously monitored during RF energy delivery.
• Irrigated ablation systems have been shown to create larger lesions than standard RF ablation catheters. Use caution when ablating near electrically vulnerable, thin-walled, or other arterial structures.
• During use of the RF generator and irrigation pump, pay attention to all messages, error codes, warnings, and tones, and exercise caution as needed.
• Perform catheter advancement under fluoroscopic guidance in conjunction with careful manipulation, electrograms, and impedance monitoring to minimize the risk of cardiac damage, perforation, or tamponade.
7
• Tip-to-tissue contact impedance is actively monitored only before and after ablation. During ablation, use caution when the temperature drops suddenly. A drop in temperature may be associated with loss of tissue contact.
• In case of steam pop or automatic shut off, discontinue RF energy. Remove the catheter for visual inspection and check for coagulum, charring, or other catheter defects.
• Always straighten the catheter before insertion or withdrawal from the patient.
• Always maintain irrigation flow to prevent coagulation within and around electrodes.
• If the irrigation flow is interrupted, withdraw the catheter from the patient, visually inspect the tip, and then flush the catheter before reinsertion and before resuming the procedure.
• Do not use the catheter if it appears damaged or kinked, or if there is any difficulty in deflecting the distal section to achieve the desired curve.
• Do not use if the catheter irrigation ports are blocked.
• Use fluoroscopy or information from a mapping system to confirm the position of the catheter during the procedure.
• Manual prebending of the distal curve may damage the steering mechanism and may cause patient injury.
• Do not immerse the proximal handle or cable connectors in fluid. Ensure that the cable and catheter connections remain dry throughout the procedure.
• Position connecting cables to avoid contact with the patient and other electrical leads.
• Do not attempt ablation with the catheter without the use of the DiamondTemp irrigation pump, the DiamondTemp generator, and approved accessories.
• After use, dispose of the catheter and packaging in accordance with hospital, administrative, and local government policy.
• Do not expose the catheter to organic solvents such as alcohol.

6 Potential adverse events

The following potential adverse events are associated with cardiac ablation procedures:
• Abnormal vision
• Air embolism
• Anaphylaxis
• Anemia
• Aneurysm
• Angina
• Arrhythmia (including new or worsening of existing condition, or requiring cardioversion)
• Arterial or venous thrombus
• Atrial septal defect
• AV fistula
• Cardiac arrest
• Cardiac tamponade
• Catheter entrapment leading to valve or heart wall damage
• Catheter insertion site hematoma
• Chest pain (non-specific)
• Congestive heart failure exacerbation
• Component damage to ICD or pacemaker
• Coronary artery dissection
• Death
• Dislodgement of implantable device or permanent pacing lead
• Dizziness
• Embolic events, including infarction of other tissues, coronary, pulmonary, and bowel structures
• Endocarditis
• Esophageal damage or necrosis
• Exacerbation of COPD
• Exacerbation of pre-existing atrial fibrillation
• Fluid overload
• Gastroparesis or GI event
• Hemorrhage
• Hemothorax
• Hypotension
• Hypoxia
• Inadvertent AV block
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• Infection
• Myocardial infarction
• Neck, back, or groin pain
• Palpitations
• Perforation (cardiac)
• Pericardial effusion
• Pericarditis
• Peripheral venous thrombosis
• Phrenic nerve damage
• Pleural effusion
• Pneumonia
• Pneumothorax
• Pseudoaneurysm
• Pulmonary edema
• Pulmonary vein stenosis
• Radiation injury resulting in dermatitis, erythema, etc.
• Renal insufficiency or failure
• Respiratory failure
• Seizure
• Sepsis
• Skin burns
• Stroke or cerebrovascular incident
• Syncope
• Thromboembolic event
• Transient ischemic attack
• Vasovagal reaction
• Ventricular arrhythmia
• Vessel wall or valvular damage or insufficiency

7 Clinical data

Study title – DIAMOND-AF: A Randomized Controlled Clinical Evaluation of the DiamondTemp Ablation System for
the Treatment of Paroxysmal Atrial Fibrillation
Number of centers – 23 centers in the United States, Canada, and Europe
Number of subjects – 482 enrolled/randomized subjects globally. There were 243 enrolled/randomized subjects in
the control (TactiCath) group and 239 enrolled/randomized subjects in the investigational (DiamondTemp) group.
Study purpose – The purpose of DIAMOND-AF was to provide data demonstrating the safety and effectiveness of the DiamondTemp Ablation System for the treatment of drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation (PAF). The study was considered successful if the investigational device was considered non-inferior to the control device for the primary safety and effectiveness endpoints.

7.1 Study Design, Study Population, Study Visits, and Length of Follow-up Methods

9

7.2 Study Endpoints

7.2.1 Primary Endpoints

7.2.1.1 Primary Effectiveness Endpoint
The primary effectiveness endpoint was defined as freedom from documented AF, atrial flutter1 (AFL) and atrial tachycardia (AT) episodes following the blanking period (3-month follow-up post-ablation procedure) through the end of the effectiveness evaluation period (12-month follow-up post-ablation procedure).
An effectiveness failure was defined by any of the following events:
• Inability to electrically isolate all accessible targeted pulmonary veins during the ablation procedure2.
• Documented episodes of AF, AFL or AT lasting ≥ 30 seconds in duration as evidenced by electrocardiographic data during the effectiveness evaluation period
• DC cardioversion for AF, AFL or AT during the effectiveness evaluation period
• A repeat ablation procedure to treat AF, AFL or AT during the effectiveness evaluation period
• Use of a new or modification to existing Class I-IV anti-arrhythmic drug (AAD) regimen to treat AF, AFL or AT recurrence during the effectiveness evaluation period
• Use of a non-study device for ablation of any AF targets during the index or repeat ablation procedure during the blanking period
• More than one (1) repeat ablation procedure during the blanking period.
7.2.1.2 Primary Safety Endpoint
The primary safety endpoint was defined as freedom from a composite of serious adverse events (SAE) occurring within 30 days and clinically symptomatic pulmonary vein stenosis through 6 months post-index ablation procedure, as adjudicated by an independent Clinical Events Committee (CEC) for relatedness to the procedure or device.
The primary safety device- or procedure-related SAE composite was a combined rate of the following events:
• Atrioesophageal fistula
• Bleeding complication
• Cardiac tamponade / perforation
• Death
• Extended hospitalization
• Myocardial infarction
• Pericarditis
• Phrenic nerve paralysis
• Pulmonary edema
• Pulmonary vein stenosis
• Stroke post-ablation
• Thromboembolism
• Transient ischemic attack (TIA) post-ablation
• Vagal nerve injury
• Vascular access complications

7.2.2 Secondary Endpoints

Secondary Endpoints and Results
There were seventeen (17) pre-defined secondary endpoints in the Diamond-AF Study, four (4) of which included hypothesis testing.
Secondary endpoints to characterize the performance of the DiamondTemp Ablation System, relative to the control device, include:
• Mean duration of individual RF ablations (seconds).
• Mean cumulative RF time per procedure (minutes).
• Freedom from a composite of SAE occurring within 7 days post-index ablation procedure as adjudicated by an independent CEC for relatedness to the procedure or device.
• Freedom from documented AF, AT and AFL3 episodes following the blanking period through 12 month follow-up post-ablation procedure in the absence of class I and III anti-arrhythmic drug therapy.
1
Occurrence and/or ablation of cavotricuspid isthmus (CTI)-dependent AFL, as confirmed by entrainment maneuvers during EP testing at any time during this study was not a primary effectiveness failure because it was not considered an iatrogenic arrhythmia following a left atrial ablation procedure for AF.
2
Electrical isolation as confirmed by demonstration of exit and/or entrance conduction block.
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