10 YEARS PROVEN PERFORMANCE

Transcription

1 References 1 Medtronic Product Performance Report, 2012 Second Edition, Issue St. Jude Medical Product Performance Report, May Boston Scientific Product Performance Report 2011, Q3 Summary Edition. 4 #M933759A001 RWA. Limited lifetime warranty, some restrictions may apply. This warranty is applicable only to Sprint Quattro leads implanted after December 1, The limited lifetime warranty applies to the performance of the lead and includes reimbursement to patients of unreimbursed medical expenses. The warranty is limited to the provisions in the written Limited Warranty document that accompanies each product. Consult the written limited warranty document for details a copy of which will be provided to the customer upon request. 5 Sweeney MO, 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, 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. doi: / 01.CIR e Based on Finite Element Analysis. Medtronic data on file. 17 Vogl, Helen. Total Sales of Sprint Quattro ICD Leads and 5076 pacing leads. Medtronic data on file. December YEARS PROVEN PERFORMANCE Brief Statement for Sprint Quattro MRI TM SureScan TM Leads (Models 6935M and 6947M) Indications Medtronic Sprint Quattro TM 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 (55 cm and 62 cm lengths of Models 6935M or 6947M) are part of the Medtronic SureScan defibrillation system. A complete SureScan defibrillation system is required for use in the MR environment and includes a Medtronic SureScan device connected to Medtronic SureScan Leads. Contraindications Medtronic leads are contraindicated for the following: ventricular use in patients with tricuspid valvular disease or a tricuspid mechanical heart valve patients for whom a single dose of 1.0 mg of dexamethasone acetate and dexamethasone sodium phosphate may be contraindicated Warnings/Precautions People with metal implants such as implantable cardioverter defibrillators (ICDs) and accompanying leads should not receive diathermy treatment, except for therapeutic ultrasound. The interaction between the implant and diathermy can cause tissue damage, fibrillation or damage to the device components, which could result in serious injury, loss of therapy or the need to reprogram or replace the device. 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 MRIspecific 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. Sprint Quattro Portfolio of Defibrillation Leads 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. 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 1 (800) and/or consult Medtronic s website at or Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Medtronic 710 Medtronic Parkway Minneapolis, MN USA Tel: (763) Fax: (763) medtronic.com Toll-free: 1 (800) (24-hour technical support for physicians and medical professionals) UC a EN Medtronic Minneapolis, MN. All Rights Reserved. Printed in USA. 08/2015

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 TM lead shows a 96% lead survival rate at 10 years when measured by active monitoring Sprint Quattro Secure Device Survival Probability % # 1 1 yr , yr , yr , yr yr yr yr Years of Active In Vivo Data Reported by Manufacturer in Product Performance Report The Most Extensive In Vivo Experience in the Market Medtronic Sprint Quattro Secure Model St. Jude Medical Durata Models 7120/ Years 6 Years 8 8 yr yr yr 11 yr 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. Boston Scientific 5 Years Endotak Reliance G Models 0164/0165/0166/0167/0184/0185/0186/ Years of Active In Vivo Data Reported by Manufacturer in Product Performance Report * US lead warranty check with your local sales representative. SPRINT QUATTRO HAS 10 YEARS OF PROVEN PERFORMANCE 1 BACKED BY A LIFETIME WARRANTY *4 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 NOW WITH 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 area 5 Integrated Bipolar Sensing Senses between the lead tip and the RV coil May cause potential oversensing due to larger sensing area 6 Pair Sprint Quattro Secure with a Medtronic SureScan ICD today; provide access to MRI scans tomorrow. Tip Ring Patients with a Sprint Quattro Secure MRI SureScan lead, coupled with a Medtronic SureScan ICD, are now able to safely undergo an MRI scan. A complete SureScan defibrillation system is required for use in the MR environment, which includes a Medtronic SureScan device connected to Medtronic SureScan Leads. Models: 6947M or 6935M Connector: DF4 Lead Length: 55, 62 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 7 : 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 7 configuration (1x19 for Model 6944) Designed to reduce stresses on the conductors in a crush situation, allowing for individual compression lumens to help reduce the risk of failure 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

5 DESIGNED FOR RELIABILITY. Exclusive Medtronic Features and Algorithms created for the lifetime of the lead. WITH MEDTRONIC S SMARTSHOCK TECHNOLOGY, WE VE MADE THE WHOLE ICD SYSTEM SMARTER. Tip seal designed to reduce fluid ingress and facilitate reinsertion of a stylet 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. Solid tip housing protects internal mechanisms from damage Conductor cable to anode crimp joint is a reliable connection Tensi-Lock cable design secures the tip assembly and provides greater lead strength, 8-11 which may aid in the lead extraction 12,13 Exclusive Medtronic Features Isoglide overlay produces an isodiametric lead body facilitating lead passage durability and lead-to-lead interaction 14 Blue lead pin (DF4 models) provides additional visual confirmation during lead insertion into DF4 header device Silicone backfilled defibrillation electrode reduces tissue growth 15 Redundant high-voltage connector in both RV and SVC defibrillation electrodes ensure uniform current distribution 16

6 TOTAL QUALITY CONTROL. Quality measures during manufacturing ensure you re consistently getting a quality product. 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. OVER 1 MILLION 17 SPRINT QUATTRO LEADS HAVE BEEN IMPLANTED WORLDWIDE. SPRINT QUATTRO HAS TEN YEARS OF PROVEN PERFORMANCE 1 BACKED BY A LIFETIME WARRANTY* * All Sprint Quattro leads are backed by the Medtronic Lifetime Limited Warranty. Backed by the Most Comprehensive Performance Monitoring System in the Industry. 4