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DHHS / FDA / CDRH 1 FDA Summary Amplatzer® Septal Occluder AGA Medical P000039.

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Presentation on theme: "DHHS / FDA / CDRH 1 FDA Summary Amplatzer® Septal Occluder AGA Medical P000039."— Presentation transcript:

1 DHHS / FDA / CDRH 1 FDA Summary Amplatzer® Septal Occluder AGA Medical P000039

2 DHHS / FDA / CDRH 2 FDA Summary FDA Review Team Device Description Nonclinical Evaluation Clinical Evaluation Panel Questions

3 DHHS / FDA / CDRH 3 FDA Review Team ODE- Donna Buckley John Stuhlmuller OSB- John Dawson OC- Liliane Brown

4 DHHS / FDA / CDRH 4 Device Description Occluder Double-disc with connecting waist LA disc size > RA disc size 26 sizes based on connecting waist diameter (range: mm) Sizing: Connecting waist diameter is matched to the stretched defect diameter

5 DHHS / FDA / CDRH 5 Device Description Delivery Catheter 6F to 12F depending on device size Occluder is packaged separately Manually attached to delivery cable Loaded into delivery catheter

6 DHHS / FDA / CDRH 6 Nonclinical Evaluation In vitro Testing Biocompatibility Testing In vivo (Animal) Testing

7 DHHS / FDA / CDRH 7 Clinical Evaluation

8 DHHS / FDA / CDRH 8 Proposed Indications for Use Closure of: 1Secundum atrial septal defects 2Fenestrations following Fontan procedure

9 DHHS / FDA / CDRH 9 Clinical Data Sets Pivotal Cohort - ASD Phase IIB patients Pivotal Cohort - Fenestrated Fontan 51 patients enrolled Non-pivotal Phase I, Phase IIA - ASD Continued Access - ASD

10 DHHS / FDA / CDRH 10 Pivotal Cohorts - ASD Device arm Non-randomized Multicenter Surgical control arm Non-randomized pro- and retrospective patient identification prospective 1-year follow-up

11 DHHS / FDA / CDRH 11 Patient Outcome Assessment Composite Clinical Success at 12 months Incorporates safety and effectiveness Patients attempted without major complication, embolization, technical failure, or significant shunt Secondary safety and effectiveness endpoints

12 DHHS / FDA / CDRH 12 ASD - Effectiveness Insert table

13 DHHS / FDA / CDRH 13 ASD - Safety

14 DHHS / FDA / CDRH 14 Pivotal Cohort - Fenestrated Fontan Open-label Single-arm registry No control

15 DHHS / FDA / CDRH 15 Patient Outcome Assessment Effectiveness  2mm shunt at 12 months Safety Adverse events

16 DHHS / FDA / CDRH 16 Fenestrated Fontan - Effectiveness Devices implanted in 46 of 48 patients attempted  2mm shunt in 32 of 32 patients at 12 months

17 DHHS / FDA / CDRH 17 Fenestrated Fontan - Safety Devices implantation attempted in 48 patients Complications - 4 patients Major - 2 patients Minor - 2 patients

18 DHHS / FDA / CDRH 18 Panel Questions

19 DHHS / FDA / CDRH 19 Question 1 - ASD Indication 1a. Please discuss whether individual endpoints, composite endpoints, or a combination of both should be used to evaluate the safety and effectiveness of the Amplatzer® ASO device?

20 DHHS / FDA / CDRH 20 Question 1 - ASD Indication 1b. The sponsor is seeking approval for device sizes from 4 mm to 38 mm. Approximately 89% of devices implanted in the pivotal ASD study were between 10 mm and 28 mm. Is there sufficient data to support approval of the entire range of devices (4 mm to 38 mm) or a specific range of device sizes?

21 DHHS / FDA / CDRH 21 Question 1 - ASD Indication 1c. Based on the data provided on ASD patients and the suggested analysis of the data from question 1a., please discuss whether these data provide reasonable assurance of safety and effectiveness.

22 DHHS / FDA / CDRH 22 Question 2 - Fontan Indication Based on the data provided on Fenestrated Fontan patients and the suggested analysis of the data from question 1a., please discuss whether these data provide reasonable assurance of safety and effectiveness.

23 DHHS / FDA / CDRH 23 Question 3 - Training Program 3a. Please discuss any improvements that could be made to the training program. 3b. More than one device was placed in 10 ASD patients. Please discuss training issues regarding the placement of multiple devices in a single patient.

24 DHHS / FDA / CDRH 24 Question 4 - Product Labeling 4a.Please comment on the INDICATIONS FOR USE section as to whether it identifies the appropriate patient populations for treatment with this device.

25 DHHS / FDA / CDRH 25 Question 4 - Product Labeling 4b. 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.

26 DHHS / FDA / CDRH 26 Question 4 - Product Labeling 4c. 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.

27 DHHS / FDA / CDRH 27 Question 4 - Product Labeling 4d. 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.

28 DHHS / FDA / CDRH 28 Question 4 - Product Labeling 4e. Please comment on the remainder of the device labeling as to whether it adequately describes how the device should be used to maximize benefits and minimize adverse events.

29 DHHS / FDA / CDRH 29 Question 5 - Post Market Evaluation Based on the clinical data provided in the PMA, do you believe that additional follow-up data or post market studies are necessary to evaluate the chronic effects of the implantation of the Amplatzer® device. If so, how long should patients be followed and what endpoints and adverse events should be measured?


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