Monitoring St. Jude Medical Device Performance

How does St. Jude Medical monitor device performance?

St. Jude Medical is committed to conducting post-market registries and studies to ensure that the healthcare community and patients are informed about the benefits, safety, reliability and quality of SJM devices and to support ongoing developments in product quality. These registries and studies make the long-term data on device performance available. 

 

Evaluation of device performance using registries:

ACT: This was a two-year registry of device performance in patients implanted with ICD or CRT-D.

SCORE: This is an active, prospective, multi-center, non-randomized, long term data collection and evaluation registry to evaluate long term performance of CRM devices. 

 

Evaluation of device performance with specific studies:

ACCURATE: This study compared accuracy and interrogation time of traditional manual/semi-automatic lead measurements with new Victory™ device/Merlin.net™ Patient Care Network (PCN) out-of-clinic lead measurements.

AFL: This study aims to demonstrate that ablation with the Therapy™ Cool Path™ Duo cardiac ablation system can eliminate typical atrial flutter and that its use does not result in an unacceptable risk of serious adverse events (SAE's).

IRASE AF: This study tests the safety and effectiveness of an irrigated ablation system for the treatment of symptomatic paroxysmal atrial fibrillation.

AGILIS: This study aims to determine whether the curative treatment of atrial fibrillation in left atrial circumferential pulmonary vein ablation is improved by using a steerable transseptal introducer into the left atrium compared to using a conventional introducer with fixed curve.

RHYTHM ICD: This study was designed to verify the safety and efficacy of the Epic® HF ICD (Model V-338) system in an ICD indicated patient population with advanced heart failure (NYHA Classification III or IV).

RHYTHM II ICD: This study assessed the safety and effectiveness of the Epic® HF ICD system with cardiac resynchronization therapy in combination with the Aescula™ left ventricular lead and other SJM left ventricular leads as they become available.

DINAMIT: This study is the first prospective study to evaluate the benefit of ICD therapy for the primary prevention of sudden cardiac death in patients at high risk after acute myocardial infarction.

SCD‐HeFT 10 Yr: This study evaluates the 10‐year mortality data on the remaining 1855 SCD‐HeFT patients since the close of follow‐up October 31, 2003. 

The ACCURATE study showed that automatic measurements by pacemakers are comparable to manual measurements and reduce measurement time by an average of 3 minutes, indicating excellent device performance.1

The CLOSE‐UP study demonstrated that the Premere™ device effectively closes PFO (>86% closure rate), and has a very low risk of adverse events.2,3

FASTER demonstrated that Proxis™ proximal embolic protection system was successfully used on 95% of 51 lesions with a mean vessel occlusion time of 4.3±2.4 minutes and aspiration volume of 11.8±6.5 ml in 31 of the patients in whom native flow reversal was sufficient.4

Studies have shown that use of the AngioSeal™ device is associated with a minimum of major complications and a low level of patient discomfort.5,6,7 Patients undergoing percutaneous coronary interventions showed significantly less time to hemostasis (p <0.001), less patient back pain (p <0.001), and less time to ambulation (p <0.001) with AngioSeal compared to manual compression.7

1Hasabnis S, Heaton W, Hiremagalur S, Burnam M, Greer S, Dahda S, Mathews S, Oza A. Efficiency in using the automated features available in modern pacemakers for follow-up: results from the Accurate registry. Europace Journal 2009, 11(Supplement 2).
2Sievert H, Kleber F, Windecker S, Uhlemann F, Tiefenbacher C, Büscheck F, Wahr DW. “PFO Closure Using Premere: The CLOSE UP Trial.” Am J Cardiol. 2005; 96(suppl 7A):93H.
3Brockes C, Rahn-Schönbeck M, Duru F, Candinas R, Turina M. Impact of automatic adjustment of stimulation outputs on pacemaker longevity in a new dual-chamber pacing system. J Interv Card Electrophysio 2003;8:45-48.
4Sievert H, Wahr DW, Schuler G, Schofer JJ, Sutsch G, Pavliska J, Skowasch M. Effectiveness and Safety of the Proxis System in Demonstrating Retrograde Coronary Blood Flow During Proximal Occlusion and in Capturing Embolic Material. Am J Cardiol. 2004; 94:1134–1139.
5Lupattelli T, Clerissi J, Clerici G, Minnella DP, Casini A, Losa S, Faglia E. The efficacy and safety of closure of brachial access using the AngioSeal closure device: experience with 161 interventions in diabetic patients with critical limb ischemia.J Vasc Surg. 2008 Apr;47(4):788.
Erratum in: J Vasc Surg. 2008 Sep;48(3):778.
6Pierot L, Herbreteau D, Bracard S, Berge J, Cognard C.An evaluation of immediate sheath removal and use of the Angio-Seal vascular closure device in neuroradiological interventions. Neuroradiology 2006; 48(1): 45-9.
7Schoenenberger U, Ammann P, Maeder M, Rickli H. Angio-Seal™ vascular closure device: an evaluation of cost effectiveness.Kardiovaskuläre Medizin 2006; 9:257-64.


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