# Presentation: 142159

## FDA Summary

**IntraCoil® Self-Expanding Peripheral Stent**
**P000033**

##  Introduction

**Non-clinical Performance**
**Clinical Summary **
**Panel Questions**

## Non-clinical Performance

***In Vitro *****Testing **
**Biocompatibility Testing**
***In Vivo***** (Animal) Testing**

## Clinical Summary

## Clinical Summary

**Randomized Trial Stent versus PTA **
**Superiority Hypothesis  **
**25% decrease in restenosis with the IntraCoil Stent**
**500 patient Sample Size**

## Clinical Summary

**Primary Endpoint **
**9 month Restenosis                    (> 50% restenosis) **
**9 month MACE (death,       Q-wave MI, target lesion revascularization) rate**** **

## Clinical Summary

**Patient enrollment slow **
**Study stopped early **
**Majority of lesions treated **_**<**_** 3cm**
**Superiority hypothesis not demonstrated**
**No significant safety concerns **

## Clinical Summary

**Subgroup of IntraCoil patients selected based on following criteria prior to stenting:**
**residual stenosis **_**>**_** 50% **
**                     ****or**
**Grade C or greater dissection **

## Clinical Summary

**Pre-dilatation vs PTA  **
**Fewer dilatations**
**Shorter dilatations**
**Lower dilatation pressure ****	****	****	**

## Clinical Summary

**Compared to PTA control group **
**no differences in **
**adverse event rate**
**effectiveness **

## Clinical Summary 

**Indications for use changed **
**from:**
** ****primary stenting for occlusive disease  **
**to:**
** ****stenting for patients meeting the subgroup criteria**

## Clinical Summary 

**Study Limitations:**
**Retrospectively selected test group **
**Relatively small sample size **
**Differences in dilatation technique **

## Panel Questions

## Panel Question 1

**1a. Please discuss the use of the suboptimal pre-dilatation classification as a surrogate for suboptimal results with PTA.**

## Panel Question 1 (cont.)

**1b. Please discuss any expected differences in terms of clinical outcomes between patients with suboptimal pre-dilatation and patients with suboptimal results from PTA. **

## Panel Question 1 (cont.)

**	**
**1c. Please discuss whether there is adequate data for a primary stent indication. **
**	****If not, what additional information would be necessary to support a primary stent indication in the femoral and/or popliteal arteries.**** **

## Panel Question 2

**2. Please discuss whether the clinical data are adequate to determine the safety and effectiveness of the IntraCoil Stent in the popliteal artery.**
** **

## Panel Question 3

**Product Labeling **
**3a.  Please Comment on the INDICATIONS FOR USE section as to whether it identifies the appropriate patient population for treatment with this device.**

## Panel Question 3 (cont.)

**Product Labeling **
**3b. Please comment on the CONTRAINDICATIONS section as to whether there are conditions under which the device should not be used because the risk clearly outweighs any possible benefit.**
** **

## Panel Question 3 (cont.)

**Product Labeling**
**3c. Please comment on the WARNINGS/PRECAUTIONS section as to whether it identifies all potential hazards regarding device use.**
** **

## Panel Question 3 (cont.)

**Product Labeling **
**3d. 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.**
**3e. Do you have any other recommendations regarding the labeling of this device? **

## Panel Question 4 

**4.****	****Please identify and discuss the items that you believe should be contained in a physician’s training program for this device.**