12 YEARS PROVEN PERFORMANCE. Sprint Quattro Defibrillation Leads

Transcription

1 12 YEARS PROVEN PERFORMANCE Sprint Quattro Defibrillation Leads

2 PROVEN PERFORMANCE. PROVEN RELIABLE. We made intentional choices and took proactive steps from lead design to active product monitoring to ensure reliability of the Sprint Quattro lead family. PROVEN BY ACTIVE MONITORING. Proven by Active Monitoring Sprint Quattro Secure 6947 lead shows a 95% lead survival rate at 12 years when measured by active monitoring Sprint Quattro Secure Device Survival Probability % # 1 1 yr , yr , yr , yr , yr , yr , yr yr yr yr yr yr SPRINT QUATTRO MODEL 6947 HAS 12 YEARS OF PROVEN PERFORMANCE 1 BACKED BY A LIFETIME WARRANTY * Medtronic s Robust Monitoring Methodology WE KNOW QUATTRO S ACTUAL PERFORMANCE Product Surveillance Registry (PSR) CareLink Plus Returned Product Analysis (RPA) Product Surveillance Registry (PSR) Prospective, non-randomized, multicenter, global clinical study. With more than 30 years of experience and over 75,000 leads evaluated proactively, the SLS is the largest and longestrunning study of its kind. Returned Product Analysis (RPA) Tracking method which provides insight into failure mechanisms. This information is trended and used to drive future improvements. CareLink Plus Program to track ICD lead integrity on over 25,000 devices, using the CareLink network and a proprietary algorithm. * This lifetime limited warranty is applicable only to Sprint Quattro leads implanted after December 1, Some restrictions apply. The limited warranty covers the performance of the lead and may include some reimbursement to patients of unreimbursed medical expenses. Consult the written Limited Warranty document for eligibility requirements and details, a copy of which is included in each product package and can be provided upon request by contacting the Medtronic Warranty team at rs.warranty@medtronic.com. Why RPA alone isn t enough: Only a portion of leads make it back to the manufacturer for analysis when no longer in use. Some remain in the body and others are discarded. Returned Product Analysis underestimates lead failure rates, which is why it is not sufficient to estimate survival. Active lead monitoring is the best estimate for actual lead survival.

3 UNMATCHED MRI ACCESS TRUE BIPOLAR PACING AND SENSING Sprint Quattro leads have true bipolar pacing and sensing. True Bipolar Sensing Senses between the lead tip and ring May reduce oversensing due to smaller sensing area2 Integrated Bipolar Sensing Senses between the lead tip and the RV coil May cause potential oversensing due to larger sensing area3 Pair Sprint Quattro with a Medtronic MRI SureScan cardiac device today; provide access to MRI scans tomorrow. Tip Ring Patients with a Sprint Quattro MRI SureScan lead, coupled with a Medtronic SureScan cardiac device, are now able to safely undergo an MRI scan when MR conditions for use are met. A complete SureScan system is required for use in the MR environment, which includes a Medtronic SureScan device connected to Medtronic SureScan leads. DF4 Models: 6946M, 6947M, 6935M Lead Lengths: 55, 62 cm DF-1 Models: 6947, 6935 Lead Lengths: 58, 65 cm True Bipolar Sensing Integrated Bipolar Sensing RV Electrode

4 DESIGNED FOR RELIABILITY. Purposeful design decisions were made to produce a lead that lasts. Insulation All silicone is not the same Many types of silicone were tested and one high performance silicone was purposefully selected for the demands of the Quattro ICD leads in vivo. High Performance Silicone Used to avoid externalization (creep), abrasion, and crush ETFE Coating Provides a necessary barrier between the cables and the silicone Asymmetrical Design Advantage High-voltage defibrillation cable conductor Compression lumens Low-voltage ring electrode cable conductor Low-voltage helix electrode coil conductor 55D Polyurethane The muscular area of the pocket can put high stresses on a lead. A relatively stiff polyurethane (55D) covers the proximal length to protect against lead crush, lead-to-lead, and lead-to-can abrasion. Compared to a symmetrical lead design, offsetting the coil and cable offers several advantages 4 : Promotes reduced tip pressure and lead body flexibility Allows for greater insulation thickness between conductors to help reduce the risk of insulation failure Facilitates increased lead strength allowing room for two cables (1 cable for Model 6935M) with a 7 x 7 configuration (1 x 19 cable configuration for Model 6944) 80A Polyurethane In the intercardiac space, forces are less but there is a greater need for flexibility to accommodate the movement of the heart. A softer, more supple polyurethane (80A) is used as an overlay between the coils. Designed to reduce stresses on the conductors in a crush situation, allowing for individual compression lumens to help reduce the risk of failure

5 DESIGNED FOR RELIABILITY. Exclusive Medtronic Features and Algorithms created for the lifetime of the lead. WITH SMARTSHOCK TECHNOLOGY, WE VE MADE THE WHOLE ICD SYSTEM SMARTER. Tip seal designed to reduce fluid ingress and facilitate reinsertion of a stylet Solid tip housing protects internal mechanisms from damage Lead Monitoring Algorithms Lead Integrity Alert (LIA) Monitors the lead at all times to provide advance warning for lead fracture and extends the VF detection time. Lead Noise Discrimination and Alert (LNDA) Identifies oversensing due to noise artifacts, provides ability to withhold therapy and notifies clinician to potential lead noise. Exclusive Medtronic Features Conductor cable to anode crimp joint is a reliable connection Tensi-Lock cable design secures the tip assembly and provides greater lead strength, 5-8 which may aid in the lead extraction 9,10 Isoglide overlay produces an isodiametric lead body facilitating lead passage durability and lead-to-lead interaction 15 Blue lead pin (DF4 models) provides additional visual confirmation during lead insertion into DF4 header device Silicone backfilled defibrillation electrode reduces tissue growth 16 Redundant high-voltage connector in both RV and SVC defibrillation electrodes ensure uniform current distribution 17

6 TOTAL QUALITY CONTROL. The Sprint Quattro lead is manufactured in Medtronic s facility in Villalba, Puerto Rico. Components are inspected and certified. The workforce is trained and certified every 6 months. Medtronic s systems, policies and procedures limit the variability of products that are built by human beings. Quality measures during manufacturing ensure you re consistently getting a quality product. OVER 1 MILLION 18 SPRINT QUATTRO LEADS HAVE BEEN IMPLANTED WORLDWIDE. References 1 MDT CRHF Product Performance esource. Sprint Quattro Data as of February 3, model/6947-sprint-quattro-secure.html 2 SweeneyMO, Ellison KE, Shea JB, Newell JB. Provoked and spontaneous high frequency, low-amplitude, respirophasic noise transients in patients with implantable cardioverter defibrillators. J Cardiovasc Electrophysiol. April 2001;12(4): Weretka S, Michaelsen J, Becker R, et al. Ventricular oversensing: a study of 101 patients implanted with dual chamber defibrillators and two different lead systems. Pacing Clin Electrophysiol. January 2003;26(1 Pt 1): Medtronic data on file. August 7, 1997; August 7, 2006; August 2007; April 9, 2012; August 3, Medtronic data on file. October 17, Medtronic data on file. October 4, Medtronic data on file. August 7, Medtronic data on file. November 2, Smith MC, Love CJ. Extraction of Transvenous Pacing and ICD Leads. Pacing Clin Electrophysiol. June 2008;31(6): Wilkoff BL, Al-Khadra AS. The Technique of Transvenous Lead Extraction. Nonpharmachological Therapy of Arrhythmias for the 21st Century: The State of the Art. Futura Publishing Co, Inc., Armonk, NY, Brief Statement MRI SureScan ICD and CRT-D Medtronic SureScan ICD and CRT-D systems are MR Conditional, and as such are designed to allow patients to undergo MRI under the specified conditions for use. When programmed to On, the MRI SureScan feature allows the patient to be safely scanned while the device continues to provide appropriate pacing. A complete transvenous SureScan system, which is a SureScan device with appropriate SureScan lead(s), is required for use in the MR environment. When a single coil SureScan defibrillation lead is used, a Medtronic DF-1 pin plug must be secured in the SVC port to make a complete SureScan DF-1 ICD or CRT-D system. To verify that components are part of a SureScan system, visit Any other combination may result in a hazard to the patient during an MRI scan. Indications: SureScan ICD systems are indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. In addition, the dual chamber devices are indicated for use in the above patients with atrial tachyarrhythmias, or those patients who are at significant risk of developing atrial tachyarrhythmias. SureScan CRT-D systems are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias and for providing cardiac resynchronization therapy in heart failure patients on stable, optimal heart failure medical therapy if indicated, and meet any of the classifications detailed in the specific device manuals. New York Heart Association (NYHA) Functional Class III or IV and who have a left ventricular ejection fraction 35% and a prolonged QRS duration. Left bundle branch block (LBBB) with a QRS duration 130 ms, left ventricular ejection fraction 30%, and NYHA Functional Class II. NYHA Functional Class I, II, or III and who have left ventricular ejection fraction 50% and atrioventricular block (AV block) that are expected to require a high percentage of ventricular pacing that cannot be managed with algorithms to minimize right ventricular pacing. Optimization of heart failure medical therapy that is limited due to AV block or the urgent need for pacing should be done post-implant. Some CRT-D systems are also indicated for use in patients with atrial tachyarrhythmias, or those patients who are at significant risk for developing atrial tachyarrhythmias. Contraindications: SureScan defibrillation ICD and CRT-D systems are contraindicated for patients experiencing tachyarrhythmias with transient or reversible causes, or patients with incessant VT or VF. For dual chamber and CRT-D devices, the device is contraindicated for patients whose primary disorder is chronic atrial tachyarrhythmia with no concomitant VT or VF. For single chamber devices, the device is contraindicated for patients whose primary disorder is atrial tachyarrhythmia. Warnings and Precautions: Changes in patient s disease and/or medications may alter the efficacy of the device s programmed parameters. Patients should avoid sources of magnetic and electromagnetic radiation to avoid possible underdetection, inappropriate sensing and/or therapy delivery, tissue damage, induction of an arrhythmia, device electrical reset, or device damage. Do not place transthoracic defibrillation paddles directly over the device. Additionally, for CRT-D devices, certain programming and device operations may not provide cardiac resynchronization. Use of the device should not change the application of established anticoagulation protocols. 11 Swerdlow CD, Gunderson BD, Ousdigian KT, et al. Downloadable algorithm to reduce inappropriate shocks caused by fractures of implantable cardioverter-defibrillator leads. Circulation. November 18, 2008;118(21): Eckstein J, Koller MT, Zabel M, et al. Necessity for surgical revision of defibrillator leads implanted long-term: causes and management. Circulation. May 27, 2008;117(21): Wilkoff BL. Aggressively programmed implantable defibrillator detection and therapy reduces shocks compared to physician-tailored programming in primary prevention patients: results from the PREPARE trial. Presented at HRS Swerdlow CD, Gunderson BD, Stadler RW, et al. Inappropriate shocks due to Sprint Fidelis ICD lead fracture may be reduced by programming more intervals for detection of ventricular fibrillation. Heart Rhythm. 2008;5 (Suppl 5S):S33. (Presented Abstract AB16-5). 15 Haqqani HM, Mond HG. The implantable cardioverter-defibrillator lead: principles, progress, and promises. Pacing Clin Electrophysiol. October 2009;32(10): Singer I, Barold S, Camm J. Nonpharmacological Therapy of Arrhythmias for the 21st Century: The State of the Art. N Engl J Med. March 4, 1999;340: Based on Finite Element Analysis. Medtronic data on file. 18 Vogl H. Total Sales of Sprint Quattro ICD Leads and 5076 pacing leads. Medtronic data on file. December Patients and their implanted SureScan ICD and CRT-D systems must be screened to meet the following requirements for MRI: No lead extenders, lead adaptors, or abandoned leads present; no broken leads or leads with intermittent electrical contact as confirmed by lead impedance history; and the system must be implanted in the left or right pectoral region. For pacemaker-dependent patients, it is not recommended to perform an MRI scan if the right ventricular (RV) lead pacing capture threshold is greater than 2.0 V at 0.4 ms. A higher pacing capture threshold may indicate an issue with the implanted lead. No diaphragmatic stimulation at a pacing output of 5.0 V and at a pulse width of 1.0 ms in patients whose device will be programmed to an asynchronous pacing mode when MRI SureScan is on. It is not recommended to perform MRI scans during the lead maturation period (approximately 6 weeks). MR Scanning Conditions: Patients may be scanned using a horizontal field, cylindrical bore, clinical 1.5T or 3T MRI system for hydrogen proton imaging, maximum spatial gradient 20 T/m, and maximum gradient slew rate performance per axis 200 T/m/s. 1.5T scanners must be operated in Normal Operating Mode (whole body averaged specific absorption rate (SAR) 2.0 W/kg, head SAR 3.2 W/kg). 3T scanners must be operated in First Level Controlled Operating Mode or Normal Operating Mode. B 1+RMS must be 2.8 μt when the isocenter (center of the bore) is inferior to the C7 vertebra. Scans can be performed without B 1+RMS restriction when the isocenter is at or superior to the C7 vertebra. For SureScan defibrillation and CRT-D systems, continuous patient monitoring is required while MRI SureScan is programmed to On. Do not scan a patient without first programming MRI SureScan to On and do not leave the device in MRI SureScan mode after the scan is complete. While MRI SureScan is programmed to On, arrhythmia detection and therapies are suspended, leaving the patient at risk of death from untreated spontaneous tachyarrhythmia. In addition, if the device is programmed to an asynchronous pacing mode, arrhythmia risk may be increased. Potential Complications: Potential complications include, but are not limited to, rejection phenomena, device migration, infection, or erosion through the skin. Potential complications associated with cardiac rhythm devices include muscle or nerve stimulation, oversensing, failure to detect and/or terminate arrhythmia episodes, acceleration of tachycardia, and surgical complications such as hematoma, inflammation, and thrombosis. Potential lead complications include, but are not limited to, valve damage, fibrillation, thrombosis, thrombotic and air embolism, cardiac perforation, heart wall rupture, cardiac tamponade, pericardial rub, infection, myocardial irritability, and pneumothorax. Other potential complications related to the lead may include lead dislodgement, lead conductor fracture, insulation failure, threshold elevation, or exit block. Potential MRI complications include, but are not limited to, lead electrode heating and tissue damage resulting in loss of sensing or capture or both, or MR-induced stimulation on leads resulting in continuous capture, VT/VF, and/or hemodynamic collapse. See the appropriate product MRI SureScan Technical Manual before performing an MRI Scan and see the device manuals for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, call Medtronic at and/or consult the Medtronic website at or

7 Brief Statement Sprint Quattro Family of Leads Indications Medtronic Sprint Quattro leads are intended for pacing and sensing and/ or defibrillation. Defibrillation leads have application for patients for whom implantable cardioverter defibrillation is indicated. The Sprint Quattro MRI SureScan leads (which include specified lengths of Models 6935, 6935M, 6947, 6947M, and 6946M) are part of a Medtronic SureScan ICD or CRT-D system. Consult individual lead model technical manuals for more detail. A complete SureScan defibrillation or CRT-D system is required for use in the MR environment and includes a Medtronic SureScan device connected to Medtronic SureScan Leads. Contraindications The Sprint Quattro leads are contraindicated as described: Atrial use for the sole use of detection and treatment of atrial arrhythmias. Ventricular use for ventricular use in patients with tricuspid valvular disease or patients with mechanical tricuspid heart valves. For patients with transient ventricular tachyarrythmias due to reversible causes (drug intoxication, electrolyte imbalance, sepsis, hypoxia) or other factors (myocardial infarction, electric shock). Do not use in patients for whom a single dose of dexamethasone acetate and/or dexamethasone sodium acetate may be contraindicated (applies to all leads that contain these steroid configurations; see model manuals for specific dosage). Warnings and Precautions People with metal implants such as pacemakers, implantable cardioverter defibrillators (ICDs), and accompanying leads should not receive certain forms of diathermy treatment. Diathermy treatments may result in serious injury or damage to an implanted device and lead system. Some lead models allow the use of therapeutic ultrasound; consult individual lead model technical manuals for more detail. Do not use magnetic resonance imaging (MRI) on patients who have non-mr conditional versions/lengths of these leads implanted as part of a complete SureScan System. MRI can induce currents on implanted leads, potentially causing tissue damage and the induction of tachyarrhythmias. MRI SureScan leads only: A complete SureScan defibrillation system is required for use in the MR environment. Before performing an MRI scan, refer to the MRI Technical Manual for MRI-specific warnings and precautions. Patients and their implanted systems must be screened to meet the following requirements for MRI: no implanted lead extenders, lead adaptors, or abandoned leads; no broken leads or leads with intermittent electrical contact as confirmed by lead impedance history; a SureScan defibrillation system implanted in the left or right pectoral region; pacing capture thresholds of 2.0 V at a pulse width of 0.4 ms; no diaphragmatic stimulation at a pacing output of 5.0 V and at a pulse width of 1.0 ms in patients whose device will be programmed to an asynchronous pacing mode when MRI SureScan is programmed to On. Patients may be scanned using a horizontal field, cylindrical bore, clinical 1.5T or 3T MRI system for hydrogen proton imaging, maximum spatial gradient 20 T/m, and maximum gradient slew rate performance per axis 200 T/m/s. 1.5T scanners must be operated in Normal Operating Mode (whole body averaged specific absorption rate (SAR) 2.0 W/kg, head SAR 3.2 W/kg). 3T scanners must be operated in First Level Controlled Operating Mode or Normal Operating Mode. B1+RMS must be 2.8 μt when the isocenter (center of the bore) is inferior to the C7 vertebra. Scans can be performed without B1+RMS restriction when the isocenter is at or superior to the C7 vertebra. Potential Complications Potential complications include, but are not limited to, acceleration of ventricular tachycardia, air embolism, bleeding, body rejection phenomena which includes local tissue reaction, cardiac dissection, cardiac perforation, cardiac tamponade, chronic nerve damage, constrictive pericarditis, death, device migration, endocarditis, erosion, excessive fibrotic tissue growth, extrusion, fibrillation or other arrhythmias, fluid accumulation, formation of hematomas/seromas or cysts, heart block, heart wall or vein wall rupture, hemothorax, infection, keloid formation, lead abrasion and discontinuity, lead migration/ dislodgement, mortality due to inability to deliver therapy, muscle and/or nerve stimulation, myocardial damage, myocardial irritability, myopotential sensing, pericardial effusion, pericardial rub, pneumothorax, poor connection of the lead to the device, which may lead to oversensing, undersensing, or a loss of therapy, threshold elevation, thrombosis, thrombotic embolism, tissue necrosis, valve damage (particularly in fragile hearts), venous occlusion, venous perforation, lead insulation failure or conductor or electrode fracture. MRI SureScan leads only: The SureScan defibrillation system has been designed to minimize potential complications in the MRI environment. Potential MRI complications include, but are not limited to, lead electrode heating and tissue damage resulting in loss of sensing or capture or both, or induced currents on leads resulting in continuous capture, VT/VF, and/or hemodynamic collapse. See the MRI SureScan Technical Manual before performing an MRI Scan and Lead Technical Manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at and/or consult the Medtronic website at medtronic.com or mrisurescan.com. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. Rev 0417 Medtronic and the Medtronic logo are trademarks of Medtronic. Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company. Medtronic 710 Medtronic Parkway Minneapolis, MN USA Toll-free in USA: Worldwide: medtronic.com UC c EN 2017 Medtronic. Minneapolis, MN. All Rights Reserved. Printed in USA. 08/2017