Product Performance Report. Implantable devices. Pacing leads. Pacemakers. Defibrillators SNIA GROUP

Transcription

1 Product Performance Report Implantable devices Pacing leads Pacemakers Defibrillators SNIA GROUP

2 A message from the chairman For ELA, quality is an essential criterion in the everyday decision making process. Quality means more than selecting and testing components or verifying their performance, even though these are absolutely necessary and performed with the highest standards at ELA. The concept of quality dominates from the beginning in the creation of a new ELA device. The excellent results obtained in the field over the years indicate that our quality policy is justified, and brings a real patient benefit. Once again, the overall results obtained this year for pacemakers and leads are excellent: 99.9% reliability. The first worldwide dual-chamber ICD has proven to be very reliable after 4 years on the market. This performance report proves that ELA Medical is able to bring together innovation and reliability in its products. The proof of our Quality commitment to the future is in the results of our past.

3 Method Methodology uses International guidelines The performance of ELA Medical implantable devices is calculated according to the International Standard Organization s guidelines. ISO standard , Reporting of clinical performance of populations of pulse generators or leads, describes the actuarial method used for preparing this report. Calculations are based on the active population, which is defined as a percentage of the cumulative implanted population. This accounts for patients who do not return for follow-up. The rate of loss to follow-up and expected patient mortality is estimated at 3 % every 6 months. Returned product analysis Reliability rates are based on the analysis of products returned to ELA Medical. The calculations assume that all implanted devices that do not meet specifications are explanted and returned to ELA Medical. The reliability rate shows the probability that a device continues to meet specifications during a given period of time. Consequently, the analysis considers only device failures. Clinical complications not related to the device failure, such as erosion or infection, are not included. End of life in conformance with specifications, and explantation with no suspicion of device failure, are considered normal and therefore are not included. This report demonstrates the excellent performance of ELA Medical s implantable devices. It covers the wide range of products that ELA Medical has provided over a 13-year period, including pacemakers, pacing leads, and defibrillators. Tables and curves display the reliability rate for each product family. The reliability rate represents the probability that a device operates according to its specifications after a specified period of time. 13 years of observation Device models are gathered into families with comparable hardware and software. Families that represent less than 1000 devices or that were commercially launched in 2001 are not reported, because results may not have reached significance. This performance report provides information on device models that are still implanted in patients today. The oldest of these devices are Chorus 6000 series pacemakers, the first implant of which occurred more than 13 years ago, in June The Focus leads, also included in this report, were implanted soon after, in January Data were compiled until the end of December All returned products explanted until that date have been taken into account. Each reliability rate considers all implanted products since the first implanted device of the corresponding family. Consequently, this report includes all available performance information, including early production data. 95% confidence intervals were calculated according to the Rothman method. The majority of these intervals are very close to the declared reliability rate. Hence, the confidence intervals have not been added to the graphics to improve legibility. For reference, confidence intervals are [99.91% %] at 5 years for the total pacemaker population and [98.61% %] at 3 years for the defibrillator population.

4 Cardiac Pacemakers Overall reliability Single-chamber pacemakers overall reliability Models Date of Total Active Failures Reliability Period first implant implanted implants rate of time 99.9% reliable is the performance of ELA Medical pacemakers over 13 years Opus 2000 series (1) June % 12.5 years Opus 3000 series (2) April % 12.5 years Opus 4000 series (3) February % 13 years Opus 4020 series (4) September % 13 years Opus RM 4534 July % 8.5 years Opus G February % 8 years Opus S October % 6 years Brio SR 112 April % 2.5 years Talent SR 113 November % 3 years TOTAL % 13 years Dual-chamber pacemakers overall reliability Models Date of Total Active Failures Reliability Period of first implant implanted implants rate time Chorus 6000 series (5) June % 13.5 years Chorus II October % 10 years Chorus RM 7034 August % 9.5 years Chorum August % 6.5 years Brio D / DR July % 3.5 years Talent D / DR June % 4.5 years TOTAL % 13 years The reliability rate is excellent for pulse generators. Rates are 99.95% for single-chamber pacemakers and 99.90% for dual-chamber pacemakers. (1) Opus 2000 series = (2) Opus 3000 series = (3) Opus 4000 series = (4) Opus 4020 series = (5) Chorus 6000 series =

5 Evolution of the reliability rate with time The following graphics show the evolution of the reliability rate over the period of implantation. The reliability rate remains very high throughout the life of the pacemakers. Single-chamber pacemakers 100% 99,8% Reliability rate (%) 99,6% 99,4% 99,2% 99% Months TALENT SR BRIO SR OPUS G OPUS S OPUS 2000 OPUS 402X OPUS OPUS RM { Dual-chamber pacemakers 100% 99,8% Reliability rate (%) 99,6% 99,4% 99,2% 99% Months TALENT D/DR BRIO D/DR CHORUS RM CHORUM CHORUS II CHORUS Failure rate The high level of reliability of the ELA Medical pulse generators is confirmed by the low number of device failures. Comparing the number of failures to the number of devices that were implanted gives failure percentages as low as 0.04% for single-chamber pacemakers (47 failures on single-chamber pacemakers implanted) 0.08% for dual-chamber pacemakers (109 failures on dual-chamber devices implanted). After analysis, the failures are mainly identified as due to excessive consumption or component dysfunction. To know the estimated longevity or the follow-up recommendations for ELA Medical pacemakers, please refer to the physician s manual or contact your ELA Medical sales representative.

6 Pacing leads Excellent reliability for leads launched since 1996 Overall reliability for leads launched since 1996 ELA Medical leads show an extremely high reliability with a majority of rates at 99.99% or 100%. Only 11 failures were noted on the leads implanted. We note that 50 % of these lead failures were seen during the implantation procedure. This early detection allows for immediate replacement of the lead, with no need for a re-intervention. Date of Total Active Failures* Reliability Period 1 st implant implanted implants rate of time STELA Bipolar BS45 - BS46 Jan % 6 years BJ44 - BJ45 Mar % 6 years BT45 - BT46 Apr % 5.5 years Unipolar UJ45 Mar % 6 years US45 - US46 Mar % 6 years UT40 - UT45 - UT46 Apr % 5.5 years STELID Bipolar BJ45D - BJ44D Jun % 4.5 years BS45D - BS46D Feb % 4 years BT26D - BT45D - BT46D Jan % 5 years Unipolar UT46D - UT45D Aug % 4.5 years STELIX BR44D - BR45D - BR46D Mar % 4 years STELID II BTF25D - BTF26D Jul % 1.5 years Half the lead failures are detected at implant Evolution of the reliability rate for leads launched since 1996 { STELA STELID Bipolar STELID II STELIX STELID Unipolar Reliability rate (%) 100% 99,8% 99,6% 99,4% 99,2% 99% Months Low failure rate for ELA s 13 year old Focus leads Focus leads reported failures Focus Leads were implanted from January 89 until The number of failures is also very low for these leads: 14 failures for implanted leads. Consequently, the failure rate is below 0.02 % of the total number of leads that were implanted. Half the failures were seen at implant, leading to the immediate use of an other lead. Date of Total Failures* 1 st implant implanted Unipolar Ventricular leads T43/T43F March T83/T83F January Bipolar Ventricular leads T44/T44F December T84F January Unipolar atrial leads J83F January S83F February Bipolar atrial leads S84F/S84V June J84F November Total FOCUS leads January The excellent performance recorded with ELA Medical leads results from the use of well-adapted and proven materials. The high-performance silicone has proven excellent insulation in long-term use. Vitreous carbon electrodes show a high biocompatibility. In addition, the MP35N multifilar conductor exhibits exceptional resistance to fatigue and corrosion in aggressive environments. * The analysis is based on leads returned to ELA Medical-Passive method. Failures detected before the introduction of the lead in the body are not included.

7 ICD Defibrillators overall reliability Models Date of first Total Active Failures Reliability implant implanted implants rate Dual chamber ICD Defender series (6) July % at 4.5 years (6) Defender series = Defender II + Defender III + Defender IV Failures were the following: Premature end of life Component failure Short-circuit Evolution of the Defender reliability rate Reliability rate (%) 100% 99% 98% 97% 96% 95% 94% 93% 92% 91% 90% Months DEFENDER Performance of the first worldwide dual-chamber defibrillator platform exceeds 99% The first worldwide dual-chamber defibrillator platform, Defender, presents an excellent reliability over a period of 4.5 years. This high performance is directly due to the expertise of ELA in dual-chamber device design, rigorous component quality checks and numerous quality controls throughout the manufacturing process. A clinical investigation precedes every new product launch to verify, once more, device safety and efficacy before worldwide use. The high reliability of Defender defibrillators proves these controls to be effective and beneficial for patient safety. To know the estimated longevity or the follow-up recommendations for ELA Medical defibrillators, please refer to the physician s manual or contact your ELA Medical sales representative.

8 Pacemakers Indications and Usage The accepted patient conditions warranting chronic cardiac pacing include: Symptomatic paroxysmal or permanent second or thirddegree AV block. Symptomatic bilateral bundle branch block. Symptomatic paroxysmal or transient sinus node dysfunctions with or without associated AV conduction disorders. Bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias. Vasovagal syndromes or hypersensitive carotid sinus syndromes. Rate adaptive pacing is indicated n patients who may benefit from increased pacing rates concurrent with increases in minute ventilation and/or activity. Dual chamber models are also indicated for dual-chamber and atrial tracking modes in patients who may benefit from maintenance of AV synchrony. Dual-chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and AV synchrony which include: Various degrees of AV block to maintain the atrial contribution to cardiac output. VVI intolerance (e.g., pacemaker syndrome) in the presence of persistent sinus rhythm. Contraindications Models with dedicated bipolar polarity, may be used in patients co-implanted with ICDs. Other models are contraindicated in patients co-implanted with an implanted cardioverter-defibrillator because these devices revert to Unipolar polarity in standby mode, which may cause unwanted delivery of ICD therapy.. Dual-chamber and single-chamber atrial pacing are contraindicated in patients with chronic refractory atrial tachyarrhythmias. Asynchronous Pacing (DOO/VOO/AOO) May be proarrhythmic in the presence (or likelihood) of competition between paced and intrinsic rhythms. Single-chamber atrial pacing is contraindicated in patients with impaired AV nodal conduction. Warning and Precautions Hospital equipment including mechanical ventilators, magnetic resonance imaging, diathermy, electrosurgical cautery, lithotripsy, external defibrillation, high radiation sources, radio frequency ablation can damage the pacemakers or cause them to be inhibited or to pace at inappropriate rates. Equipment in the home or in occupational environments including high voltage power lines, high power communications transmitters, arc or resistance welders, induction furnaces, retail theft prevention systems, ungrounded home appliances and cellular phones may cause inappropriate sensing or therapy. Do not use combined or minute ventilation pacing for abdominal or epicardial implants. Certain diagnostic modes provide no pacing. Do not resterilize or reuse. Use only IS-1 compatible leads. Minute ventilation pacing may be inappropriate for patients with respiration rates greater than 48 breaths per minute. Side Effects Observed adverse events included oversensing, loss of sensing, loss of capture, lead connector problems, lead dislodgment, phrenic nerve stimulation, irritation at implant site, hemo and pneumothorax, minute ventilation noise, overpacing protection, programming errors, medication induced threshold elevation, and pacemaker syndrome. Refer to the physicians manuals for a complete listing of indications, contraindications, precautions and warnings. Endocardial leads Indications ELA Medical s endocardial leads are designed to be used with implantable cardiac pulse generators. Preformed J-shaped leads are intended for permanent pacing and sensing of the atrium. Straight leads can be used in the ventricle or the atrium. Contraindications The use of ventricular endocardial leads is generally contraindicated in patients presenting with tricuspid atresia or mechanical tricuspid valves. Warnings and Precautions A defibrillator should always be available during implantation of the lead. Only battery-operated electrical appliances should be used during the implant procedure. AC electrical appliances should not be placed near the patient. All operating room electrical appliances must be grounded. Do not use electrocautery near an implanted pacemaker. Adverse Events Possible adverse events include pneumothorax, hemothorax, embolism, thrombosis, infection, cardiac ectopy, cardiac tamponade, phrenic nerve stimulation, muscles stimulation, loss of pacing and or sensing due to dislodgement or mechanical failure of the lead. Refer to the physician s manual for a complete listing of indications, contraindications, warnings, and precautions. Defibrillators Intended Uses Implantable Cardioverter Defibrillators (ICDs) are indicated for use in patients who are at high risk or sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations. (a) Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmias. (b) Recurrent, poorly tolerated sustained ventricular Tachycardia (VT). Note: The clinical outcome for hemodynamically stable VT patients is not fully known. Safety and effectiveness studies have not been conducted. Contraindications Use of ICDs is contraindicated in (a) Patients whose ventricular tachyarrhythmias may have transient or reversible causes such as acute myocardial infarction, digitalis intoxication, drowning, electrocution, electrolyte imbalance, hypoxia or sepsis. (b) Patients with incessant VT or VF. (c) Patients who have unipolar pacemaker. (d) Patients whose primary disorder is bradyarrhythmias or atrial tachyarrhythmias. (e) Dual chamber and single chamber atrial pacing is contraindicated with chronic refractory atrial tachyarrhythmias. Warnings and Precautions Do not perform device testing unless an external defibrillator and medical personnel skilled in cardiopulmonary resusicitation (CPR) are readily available. Do not allow patient to come in contact with grounded equipment that could produce hazardous current leakage. Program the shock therapy to OFF during surgical implant and explant or post-mortem procedures. Be aware that the changes in the patient s condition, drug regimen, and other factors may change the defibrillation threshold (FDT) which may result in non-conversion of the arrhythmia post-operatively. Patients should be directed to avoid devices that generate a strong electric or magnetic interference (EMI). External defibrillation may damage the generator or may result in temporary and/or permanent myocardial damage at the electrode-tissue interface as well as temporary or permanent elevated pacing thresholds. Magnetic resonance imaging (MRI) may cause device malfunction or damage. If MRI must be used, patients should be closely monitored and programmed parameters should be verified upon cessation of MRI. Side Effects These include, but are not limited to: lead migration or dislodgment, pocket infection or hematoma, ventricular oversensing, inappropriate therapy, ineffective therapy, pneumothorax, prolonged implant procedure, and change in sensing or pacing thresholds. Refer to the physicians manuals for a complete statement of intended uses, relevant warnings, precautions, side effects, and contraindications. The following devices are investigational in the United States: Leads: STELIX BR44D, BR45D and BR46D models, STELID II BTF25D and BTF26D models. The safety and effectiveness of these devices has not been established The following devices are not available for distribution in the United States: Pacemakers: OPUS 4006, CHORUS 6005, CHORUS 6035, CHORUS 6043, CHORUS II 6234, CHORUS II 6244, CHORUM 7234, CHORUM 7334,TALENT D 210, TALENT II D 230. Leads: All STELID models, STELA BS45, STELA BS46, STELA US45, STELA US46, FOCUS T43, FOCUS T44, FOCUS S83F, FOCUS S84F, FOCUS S84V, FOCUS J84F Defibrillators: DEFENDER III SNIA GROUP ELA Medical - C.A. La Boursidière Le Plessis-Robinson Cedex - France Tel. : 33 (0) Fax : 33 (0) Médiasquare - 06/ XZA937 - Data subject to change