SUMMARY OF SAFETY AND EFFECTIVENESS DATA …

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)

I. GENERAL INFORMATION

Device Generic Name:

Product Code: NIP- Stent. Superficial Femoral Artery

Device Trade Name:

S.M.A.R.T.? CONTROL? and S.M.A.R.T.? Vascular Stent Systems

Applicant's Name and Address:

Cordis Corporation, a Johnson & Johnson Company

14201 NW 601h Avenue

?

Miami Lakes, FL 33014

Date(s) of Panel Recommendation: N/A

Premarket Approval Application

(PMA) Number:

P120002

Date of FDA Notice of Approval: November 7, 2012

II. INDICATIONS FOR USE

The Cordis S.M.A.R.T_? CONTROL?; S.M.A.R.T.? Vascular Stent System is indicated for use to improve luminal diameter in the treatment of patients with de novo or restenotic native lesion(s) of the superficial femoral artery and/or proximal popliteal artery with total

length up to 150 mm and with a reference vessel diameter ranging from 4 mm to 7 mm.

III. CONTRAINDICATIONS

? Patients with a known hypersensitivity to nickel titanium. ? Patients who cannot receive antiplatelet or anticoagulation therapy. ? Patients who are judgyd to have a lesion that prevents complete inflation of an

angioplasty balloon or proper placement ofthe stent or stent delivery system.

IV. WARNINGS AND PRECAUTIONS

The Warnings and Precautions can be found in the Instructions for Use for the Cordis S.M.A.R.T.? CONTROL? and S.M.A.R.T.? Vascular Stent Systems

V, DEVICE DESCRIPTION

PMA P 120002: FDA Summary of Safety and Effectiveness Data

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The S.M.A.R.T.? CONTROL? and S.M.A.R.T.?Vascular Stent Systems consist of a self expandingstent made ofNitinol (nickel-titanium alloy) material that is pre-mounted on an over-the-wire delivery system. The stents contain tantalum markers at each end.

The S.M.A.R.T.? CONTROL? and S.M.A.R.T.? stents are provided in multiple lengths and diameters. Table I lists the available stent diameters and len!,'ihs for the S.M.A.R.T.? CONTROL? and S.M.A.R.T.?Vascular Stent Systems.

Table I S.M.A.R.T.? Stent Sizes S.M.A.R.T.~ CONTROL~ Stent System (Handle)

I~ 20mm

30mm

6mm

X

X

7mm

X

X

8mm

X

X

0- Diameter L-Length

40mm

X X X

60mm

X X X

80mm

X X X

100mm

X X X

S.M.A.R.T.~ Stent System

(Pin/Pull) 120 mm 150 mm

X

X

X

X

X

X

The S.M.A.R.T.? CONTROL? and S.M.A.R.T.? Vascular Stents are designed to open to a pre-programmed diameter at body temperature. Figure 1 provides an illustration ofthe stent.

Figure 1- S.M.A.R.T.? Stent

Magnified view of the

There are two delivery system configurations, S.M.A.R.T.? CONTROL? and S.M.A.R.T.?, which are illustrated in Figures 2 and 3, respectively. The stent is contained within the outer sheath of the delivery system. Once the distal end of the delivery system reaches the treatment site, the outer sheath ofthe delivery system is retracted to expose the stent and start its self-expansion. For the S.M.A.R.T.? CONTROL? Stent System, sheath retraction is achieved by grasping the handle in a fixed position with the tuning dial held between the thumb and index fingers, and rotating the tuning dial in a clockwise direction until the distal end of the stent is visibly apposed to the vessel wall. For the S.M.A.R.T@ Stent System, sheath retraction is achieved by grasping the inner shaft in a fixed position and moving the outer sheath proximally relative to the inner shaft.

The stents for the S.M.A.R.T.? CONTROL? system are available in diameters of 6, 7, and 8 mm and in lengths of20, 30, 40, 60, 80, and 100 mm. The stents for the S.M.A.R.T.? system are also available in diameters of6, 7, and 8 mm and in lengths of 120 and 150 mm. The S.M.A.R.T.? CONTROL? delivery system uses a handle controlled mechanism to

PMA I' 120002: FDA Summary of Safety and Effectiveness Data

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deploy the stent. This delivery system is available in lengths of 80 and 120 em. The S.M.A.R.T.? delivery system uses a "pin/pull" mechanism. This delivery system has a length of 120 em. Both delivery systems are compatible with 6F sheath introducers and with 0.035 guidewires.

PMA I' 120002: FDA Summary of Safety and Effectiveness Data

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Figure 2- S.M.A.R.T.? CONTROL? Delivery System

Detaii"A"

I Flushing valve 2 Inner shaft: polymeric tube J Inner shaft: metallic tube 4 Inner shaft: metallic coil 5 Catheter tip (Distal wire lumen) 6 Luer hub (proximal wire lumen) 7 Outer sheath 8 Luer hub (Outer Sheath) 9 S.M.AR.T. stent

10 Inner Shaft stcnt stop II Distal radiopaque marker 12 Distal stcnt markers 13 Proximal stcnt markers 14 Locking pin 15 Handle 16 Tuning dial 17 Deployment lever

Fi ure 3- S.M.A.R.T.? Deliver S stem

(

'*?---- G)

/

'-/

J~

c-0 DETAIL "A"

~~ fo) (0

.;~.~v =--.1_'

I Tuohy Borst valve 2 Inner shaft: metallic tube 3 Inner shaft: Polymeric tube 4 Catheter tip (Distal wire lumen) 5 Luer hub (outer sheath) 6 Outer sheath 7 Lucr hub (proximal wire lumen)

8 S.MAR.T. Stent 9 Y connection on the Tuohy Borst valve I0 Inner shaft stent stop II Distal Radiopaque marker 12 Distal stent marker 13 Proximal stent marker 14 Proximal valve of the Tuohy Borst valve

PMA P 120002: FDA Summary of Safety and Effectiveness Data

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VI. ALTERNATIVE PRACTICES AND PROCEDURES

There are several other alternatives for the treatment of atherosclerotic disease of the superficial femoral and proximal popliteal arteries. Each alternative has its own advantages and disadvantages. A patient should fully discuss these alternatives with his/her physician to select the method that best meets expectations and lifestyle.

These alternative practices and procedures include: ? Non invasive lifestyle modifications (e.g., exerctse, weight control, cessation of

smoking); ? Drug therapy; ? Minimally invasive endovascular procedures (e.g., balloon angioplasty, stent

placement, stent graft placement and atherectomy); or ? Surgical intervention (e.g., by-pass)

VII. MARKETING HISTORY

The S.M.A.R.T.? CONTROL? and S.M.A.R.T@ Vascular stent systems, developed and manufactured by Cordis, were previously cleared/approved by FDA for palliation of malignant neoplasms in the biliary tree in 1998, for the treatment of stenotic lesions in iliac arteries in 2003, and have been commercially available in the United States since then.

The stent systems for SFA indication are identical to the systems cleared/approved for use in the biliary tree and iliac arteries. These products are also being marketed for vascular indications in a large number of countries outside the United States.

Since 2000, Cordis has executed 5 recalls on the SMART? stent family of products. In 2000, Cordis executed a recall on 2 lots of product which were packaged in the incorrect carton. The issue was caused by human error and it was addressed via retraining personnel. In 2003, a recall was executed for deployment difficulties on SMART? CONTROL? vascular codes marketed outside the United States; the deployment difficulty was attributed to design and it was addressed via a?minor design change. The third recall took place in 2008, when ten lots of one catalog number were recalled due to a manufacturing error which resulted in the use of a prior version of wire lumen material. The error was caused by a transcription error between the documentation system and the manufacturing information system. A Corrective Action and Preventive Action (CAPA) file was opened and the issue was fully resolved. In February 2012, Cordis initiated a recall of the SMART? CONTROL? product due to observations of small channels in the seal of the package detected during product testing. The defect was attributed to lack of adhesive transfer due to inconsistent execution of the process. A Corrective and Preventive Action (CAPA) file was opened to address the finding and product distribution was restored. On April 9, 2012, Cordis initiated a limited recall on32 lots of SMART? Cordis Nitinol Stent Transhepatic Biliary System and SMART? CONTROL? Nitinol Stent Transhepatic

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