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FDA Summary

FDA Summary. CardioSEAL® Septal Occlusion System with Qwik Load NMT Medical P000049. FDA Summary. FDA Review Team Device Description HDE Approval Nonclinical Evaluation Clinical Evaluation Panel Questions. FDA Review Team. ODE - Donna Buckley John E. Stuhlmuller

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FDA Summary

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  1. FDA Summary CardioSEAL® Septal Occlusion System with Qwik Load NMT Medical P000049

  2. FDA Summary • FDA Review Team • Device Description • HDE Approval • Nonclinical Evaluation • Clinical Evaluation • Panel Questions

  3. FDA Review Team • ODE - Donna Buckley John E. Stuhlmuller • OSB - Lakshmi Vishnuvajjala • OC - Liliane Brown

  4. Device Description • Occluder • Double umbrella design • Size range: 17 - 33 mm • Device size : Stretched defect diameter ratio is 1.7-2.0 : 1

  5. Device Description • Delivery Catheter • Size: 10F • Qwik Load device • Used to collapse and load occluder into the delivery catheter

  6. Humanitarian Device Exemption • Similar to PMA application • Exempt from effectiveness requirements • Humanitarian Use Device • Device that is intended to benefit patients in the treatment and diagnosis of diseases or conditions that affect fewer than 4,000 individuals in the United States.

  7. Humanitarian Device Exemption • CardioSEAL® device approved under H990005 in September 1999 • Same intended use as PMA

  8. Nonclinical Evaluation • In Vitro Testing • Biocompatibility Testing • In Vivo (Animal) Testing

  9. Clinical Evaluation

  10. Clinical Data Sets • Pivotal Cohort - VSD • Non-pivotal • Clamshell I F/U - VSD • High-Risk Registry - non-VSD • Clamshell I F/U - non-VSD • Acquired VSD - s/p MI

  11. Pivotal Cohort - VSD • Patient subset of High-Risk Registry • Open-label, single arm • No control group • Meets criteria for “Compassionate Use” • Primarily single-center study

  12. Pivotal Cohort - VSD • 74 patients • Devices placed in 57 of 58 patients attempted • Multiple procedures - 6 patients • Multiple devices - 26 patients

  13. Patient Outcome Assessment • Effectiveness • Clinical Status Scale (CSS) • Safety • Adverse Events

  14. Patient Outcome Assessment • Clinical Status Scale • Developed at Boston Children’s Hospital • 8 nominal variables each using an ordinal scale • Change of 1 on ordinal scale is clinically meaningful change

  15. VSD - Effectiveness • Effectiveness determined at 6-month F/U • 44 of 57 implanted patients • Anatomical Scale - 14 patients • L to R Shunt - 22 patients • Different scales - 8 patients • Pre - Anatomical & Post - L to R Shunt

  16. VSD - Effectiveness • Pre-procedure and 6-month follow-up • 44 of 57 implanted patients • Median change of 2 categories • 84% of procedures successful at 6 months

  17. VSD - Safety • Assessment at 1, 6, 12, and 24 months • Characterization of adverse events • Device related • arm fractures • Implantation related • Catheterization related

  18. VSD - Safety • Adverse events in 57 of 58 patients • Total of 222 events • Device - 32 • Implantation - 35 • Catheterization - 85 • Arm fractures in 34 of 107 devices

  19. Panel Questions

  20. Question 1- Safety and Effectiveness 1a. Based on the information provided, please discuss the description “complex VSD” as the defining indication for use of the CardioSEAL® for VSD closure.

  21. Question 1- Safety and Effectiveness 1b. In the absence of a control group, please discuss how to evaluate the safety and effectiveness of the CardioSEAL® device.

  22. Question 2 - Safety and Effectiveness 2.Does the use of the Clinical Status Scale allow for a clinically meaningful assessment of effectiveness for the device?

  23. Question 3 - Safety and Effectiveness 3. Based on the data provided and your comments regarding questions 1 and 2, please discuss whether these data provide reasonable assurance of safety and effectiveness.

  24. Question 4 - Training Program 4a. Please discuss any improvements that could be made to the training program. 4b. Please discuss training issues regarding the placement of multiple devices in a single patient.

  25. Question 5 - Product Labeling 5a. Please comment on the INDICATIONS FOR USE section as to whether it identifies the appropriate patient populations for treatment with this device.

  26. Question 5 - Product Labeling 5b. Please comment on the CONTRAINDICATIONS section as to whether there are conditions under which the device should not be used because the risk of use clearly outweighs any possible benefit.

  27. Question 5 - Product Labeling 5c. Please comment on the WARNING/PRECAUTIONS section as to whether it adequately describes how the device should be used to maximize benefits and minimize adverse events.

  28. Question 5 - Product Labeling 5d. Please comment on the OPERATOR’S INSTRUCTIONS as to whether it adequately describes how the device should be used to maximize benefits and minimize adverse events.

  29. Question 5 - Product Labeling 5e. Please comment on the remainder of the device labeling as to whether it adequately describe how the device should be used to maximize benefits and minimize adverse events.

  30. Question 6 - Post-Market Evaluation 6. Do you believe that additional follow-up data or post market studies are necessary to evaluate the chronic effects of the implantation of the CardioSEAL® device? If so, how long should patients be followed and what endpoints and adverse events should be measured?

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