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St. Jude Medical Tendril MRI LPA1200M, User Manual

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St. Jude Medical Tendril MRI LPA1200M User Manual Download Page 14

 

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Figure 2.  MRI Phase 

 

 

 

Study Objectives 

The objective of this clinical study was to verify the safety and efficacy of the 
Accent MRI

™

 pacemaker system indicated for implant of a pacemaker within and outside of the 

MRI environment. 

Primary Objectives 

The following are the primary safety and efficacy objectives defined for this study. 

Summary of Contents for Tendril MRI LPA1200M

Page 1: ...Tendril MRI Pacing leads Model LPA1200M User s Manual ...

Page 2: ...cer and birth defects or other reproductive harm For more information go to www P65Warnings ca gov Unless otherwise noted indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL and the nine squares symbol are trademarks and service marks of St Jude Medical LLC and its related companies Pat http patents sjm com 2018 St Jude Medical LLC Al...

Page 3: ...permanent sensing and pacing in either the right atrium or the right ventricle in combination with a compatible device Active leads such as the Tendril MRI lead may be indicated for patients where permanent fixation of a passive lead is suspected to be unstable In atrial applications the use of screw in leads such as Tendril MRI lead may be indicated in the presence of an abnormal surgically alter...

Page 4: ...ic attraction for particulate matter do not expose them to lint dust or other such materials Avoid touching or handling the lead tip electrode itself Do not immerse the lead body in mineral oil silicone oil alcohol or any liquid other than sterile saline or injectable fluid Do not immerse the tip electrode in any fluid prior to implantation immersion of the electrode may cause a small amount of st...

Page 5: ...ent that is submitted by the investigator which is not caused by or associated with the study device and or system component s and or defined as an Adverse Event Reported Adverse Events The tables below list the observations and complications reported from the MRI Study see Summary Of Clinical Study page 9 A total of 168 adverse events have been reported in 139 patients of which 68 are complicatio...

Page 6: ...s Syndrome 1 0 11 1 0 001 Undersensing RA Lead 1 0 11 1 0 001 Wound dehiscence 1 0 11 1 0 001 Observations total 87 9 46 100 0 065 Atrial Arrhythmia 3 0 33 3 0 002 Bleeding Hematoma 9 0 98 9 0 006 Cellulitis thrombophlebitis 1 0 11 1 0 001 Cerebrovascular accident 1 0 11 1 0 001 Decompensated HF 2 0 22 2 0 001 Elevated pacing thresholds RA Lead 3 0 33 3 0 002 Elevated pacing thresholds RV Lead 1 0...

Page 7: ...98 9 0 006 Undersensing RA Lead 2 0 22 2 0 001 Undersensing RV Lead 2 0 22 2 0 001 Undersensing PG 1 0 11 1 0 001 Table 2 MRI study events not adjudicated as either observations or complications ORE Description of Patients2 of Events Comments Acute Encephalopathy 1 1 Hospitalized for general weakness altered mental status and mild CHF Angina 6 7 Patients hospitalized for chest pain angioplasty per...

Page 8: ... patients Medication was adjusted on two patients one of which had cardiac catheterization Compression Fracture L2 Vertebral Body 1 1 Patient treated with Kyphoplasty Decompensated Heart Failure 9 9 Medications added or adjusted One patient died due to multiple comorbidities Device Upgraded to CRT 1 1 Tendril MRI RA lead retained Patient remains active in study Electromagnetic Interference 1 1 Eve...

Page 9: ...ant Pulmonary Edema 1 1 Noted on chest x ray no intervention required Shock Hypotension 2 2 One patient treated with medication one patient expired death unrelated to device study procedures Shortness of Breath 2 2 Device was reprogrammed in one patient No action taken the other patient Syncope 2 2 Device reprogrammed Thrombocytopenia 1 1 Unresolvable multiple comorbidities Thrombo embolic Event 2...

Page 10: ...ce or leads causing the system to fail to detect or treat irregular heartbeats or causing the system to treat the patient s condition incorrectly Damage to the functionality or mechanical integrity of the device resulting in the inability to communicate with the device Movement or vibration of the device or leads Lead dislodgment Competitive pacing and potential for VT VF induction if asynchronous...

Page 11: ...xcessive bleeding Induced ventricular ectopy Infection Loss of pacing and or sensing due to dislodgement or mechanical malfunction of the pacing lead Thrombosis Complications reported with direct subclavian venipuncture include pneumothorax hemothorax laceration of the subclavian artery arteriovenous fistula neural damage thoracic duct injury cannulation of other vessels massive hemorrhage and rar...

Page 12: ...as a prospective multi center clinical investigation consisting of a Lead Safety Phase and an MRI Phase designed to evaluate the safety and efficacy of the Accent MRI pacemaker system indicated for implant of a pacemaker within and outside of the MRI environment The products being evaluated were the Accent MRI pacemaker Tendril MRI lead and the SJM MRI Activator handheld device The Lead Safety Pha...

Page 13: ...11 Figure 1 Lead Safety Phase The figure below depicts the MRI Phase ...

Page 14: ...nical study was to verify the safety and efficacy of the Accent MRI pacemaker system indicated for implant of a pacemaker within and outside of the MRI environment Primary Objectives The following are the primary safety and efficacy objectives defined for this study ...

Page 15: ... all of the following 1 Had an approved indication per ACC AHA HRS guidelines for implantation of a pacemaker 2 Received a new pacemaker and lead 3 Was willing to undergo an elective MRI scan without sedation 4 Was able to provide informed consent for study participation legal guardian is NOT acceptable 5 Was willing and able to comply with the prescribed follow up tests and schedule of evaluation...

Page 16: ...2218 pacemaker and Tendril MRI LPA1200M leads were implanted on March 30 2012 Of the 920 patients enrolled in the MRI Study 918 were successfully implanted with an Accent MRI pacemaker system Two implants were unsuccessful due to an inability to implant the Tendril MRI lead due to difficulty in obtaining access in one patient and a persistent left SVC in the other patient Both patients received a ...

Page 17: ...ient months The average time of follow up was 20 00 4 66 range 0 09 to 30 68 patient months Demographic Data As part of the Lead Safety Phase of the MRI Study patients who were successfully implanted with the Accent MRI pacemaker system were seen at a pre discharge visit during which the following tests assessments were performed electrical measurements on the RA and or RV leads and identification...

Page 18: ...MRI visit the following tests assessments were performed assessment for adverse events including MRI scan related adverse events and electrical measurements on the RA and or RV leads The table below summarizes all the reported data on the 920 patients who completed the implant visit Table 4 Summary of demographic variables for all enrolled patients Demographic Variable All Enrolled Patients N 920 ...

Page 19: ...ables for all patients contributing data to the MRI phase Demographic Variable Patients Enrolled in the MRI Study N 225 Patients Contributing Supplemental MRI Scan Data N 30 Total N 255 Age Mean SD 69 8 11 6 73 0 5 9 70 2 11 1 Range min max 30 0 92 0 59 0 81 0 30 0 92 0 Gender n Female 98 43 6 16 53 3 114 44 7 Male 127 56 4 14 46 7 141 55 3 Cardiovascular History n Coronary Artery Disease 26 11 6 ...

Page 20: ...ted complication free survival at the two month follow up visit was calculated as 97 20 with a 95 lower confidence bound of 95 81 which is greater than the objective performance criterion of 92 RV Lead Related Complications Implant through 2 month visit Nine hundred nineteen 919 patients who had a Tendril MRI lead attempted or successfully implanted were analyzed for this endpoint Ten RV lead rela...

Page 21: ...s greater than the objective performance criterion of 90 MRI RV Lead Capture Threshold Efficacy One hundred sixty seven 167 patients who were implanted with an RV lead received a study scan and had capture threshold data pre and one month post MRI scan were included in this analysis The proportion of patients who experienced a capture threshold increase of 0 5 V at 0 5 ms from before to the one mo...

Page 22: ...dence bound of 97 98 which is greater than the objective performance criterion of 85 Additional Data Patient Discontinuation Withdrawals A total of one hundred and five 105 patients participating in MRI Study were withdrawn from the study Two 2 patients were withdrawn approximately one month after unsuccessful system implants in accordance with the protocol Fifty six 56 patients died and were also...

Page 23: ... and review the implantation instructions select an appropriate venous route select and install an appropriate stylet test the mechanical function of the helix confirm the helix is completely retracted before implantation The Fixation Tool Selected St Jude Medical stylet kits6 include a simple fixation tool designed to insert and secure the stylet in the lead and to allow extension and retraction ...

Page 24: ...he fixation tool Test the Mechanical Operation of the Helix with the Fixation Tool Before implanting the lead the mechanical operation of the helix should be tested With both thumbscrews secured and with the fixation tool in one hand hold the lead stationary with the other hand Extend the helix by using the thumb and forefinger to rotate only the gray portion of the tool in the direction of the ar...

Page 25: ...tract the helix by rotating the fixation tool counterclockwise Test the Mechanical Operation of the Helix with the Clip On Tool For information on using the clip on tool see Secure the Tip with the Clip On Tool page 25 Using the Vein Lifter A vein lifter is supplied to facilitate the introduction of the lead into a free standing vein Insert the tip of the vein lifter into the vein incision and gen...

Page 26: ...l instruments Do not leave a lead unconnected in a patient unless the lead is capped Position the Lead Confirm that the helix is completely retracted before implantation NOTE If blood clogs the helix repositioning may require a greater number of pin rotations to extend the helix Repeated repositioning attempts may impair the helix extension mechanism Atrial Lead Placement 1 Using a straight stylet...

Page 27: ...red Ventricular Lead Placement 1 Advance the lead into the atrium 2 Pull the stylet back a few centimeters to reduce the risk of the lead damaging the valves or penetrating the heart muscle when it continues down into the ventricle 3 Continue to advance the lead When the tip reaches the desired implant location retract the stylet an additional ten centimeters or more 4 With the clip on tool or the...

Page 28: ...26 Figure 10 Open the clip on tool 1 Insert lead into notch ...

Page 29: ...on sheet for the approximate number of turns required for each lead length On the fluoroscopic image the helix will be extended beyond the marker ring The helix is fully extended when two turns of the helix extend past the marker ring as shown in the following figure It may be necessary to reposition the fluoroscopy camera or to advance the lead body in order to see the entire helix Figure 12 Exte...

Page 30: ... Analyzer Remove the stylet from the lead once the lead is in what is believed to be a suitable location Exercise caution when applying alligator clips to the lead s connector pin to avoid damaging the insulation between terminals For more information on the use of the PSA please refer to the PSA manual Recommended Values If the initial measurements are different from those recommended in the foll...

Page 31: ...ry regrip the lead and continue to insert the lead connector until it is fully seated in the device port CAUTION Orient the excess lead length and the device to minimize the potential for insulation damage resulting from lead to lead or device to lead interaction For example minimize the potential for leads lying on top of each other under the device and ensure that there are no sharp bends in the...

Page 32: ...d explanted for any reason should never be implanted in another patient If the lead or any portion of it is extracted return it to the manufacturer It is generally recommended that a chronically implanted endocardial pacing lead not be repositioned except in special circumstances Out of Service Explant Patient Death Form Return all extracted leads whether intact or not and all unused leads to St J...

Page 33: ...nsulation Tip and ring electrodes Titanium nitride coated platinum iridium alloy Soft tip Silicone rubber Lead tip header PEEK titanium Total steroid dose monolithic controlled release device MCRD 460 micrograms dexamethasone sodium phosphate DSP MR Conditional markers Platinum Suture sleeve Silicone rubber Stylet Stainless steel Typical number of rotations to extend helix for initial placement11 ...

Page 34: ...le 9 Accessories Lead cap Vein pick Suture sleeve Stylet Kit with Clip On Tool Stylet Kit with Fixation Tool Locator Plus Deflectable Stylet Stylet Color Codes Table 10 Stylet Color Code Knob color Description Diameter Green Soft straight 20 mm taper 0 014 in 0 35 mm Light green Extra soft straight 40 mm taper 0 014 in 0 35 mm Green white dot Soft J 20 mm taper 0 014 in 0 35 mm ...

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Page 38: ...anagement Division 15900 Valley View Court Sylmar CA 91342 USA 1 818 362 6822 St Jude Medical Coordination Center BVBA The Corporate Village Da Vincilaan 11 Box F1 1935 Zaventem Belgium 32 2 774 68 11 sjm com 2018 12 ARTEN100167850 A ...

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