SUMMARY OF SAFETY AND EFFECTIVENESS

**[I. General Information]{.smallcaps}**

**Device Generic Name:** Percutaneous Transluminal Coronary Angioplasty
Catheter

**Device Trade Name:** FX miniRAIL RX Percutaneous Transluminal
Coronary Angioplasty (PTCA) Catheter

**Premarket Approval (PMA) Number:** P020037

**Date of Panel Recommendation:** none

**Name/Address of Applicant:** X Technologies, Inc.\
15042 Parkway Loop, Suite A\
Tustin, California 92780

**Date of Notice of Approval**

**to the Applicant :** June 11, 2003

**[II. Indications]{.smallcaps}**

The FX miniRAIL™ Catheter is indicated for balloon dilatation of the
stenotic portion of a coronary artery, including in-stent restenosis,
for the purpose of improving myocardial perfusion.

**III. [Contraindications]{.smallcaps}**

-   Unprotected left main coronary artery

-   Coronary artery spasm in the absence of significant stenosis

**IV. [Warnings and Precautions]{.smallcaps}**

> A list of warnings and precautions can be found in the device
> labeling.

**V. [Device Description]{.smallcaps}**

The FX miniRAIL is a PTCA catheter, which features a semi-compliant
balloon that is designed to expand to a specified diameter and length at
a specified pressure. The balloon is connected to a distal tip, which
houses a short guidewire lumen. The proximal end of the balloon is
connected to an inflation channel, which floats freely inside a
stainless steel hypotube catheter shaft. A pull wire connects the
hypotube shaft to the distal tip. Two radiopaque markers are mounted on
the pull wire such that they delineate the working segment of the
balloon and facilitate fluoroscopic visualization of the balloon during
use. The device is available in balloon diameters of 2.0-4.0 mm and
lengths of 10-30 mm.

The FX miniRAIL™ design has the following structural and functional
characteristics:

-   Pushing force is transmitted from the catheter shaft through the
    pull wire to the distal tip.

-   The dilatation balloon and inflation channel are separated from the
    catheter shaft to minimize the catheter crossing profile.

-   The guidewire lumen is 12 mm in length. This facilitates single
    operator catheter exchange.

The balloon is designed to be inflated both against the stationary
guidewire and the pull wire to concentrate the dilatation force exerted
on the lesion.

**[VI. Alternative Practices/Procedures]{.smallcaps}**

Alternative treatments for coronary artery disease include medical
therapy, coronary atherectomy, coronary laser, coronary stent, coronary
endarterectomy, coronary artery bypass graft surgery, and other
commercially available PTCA catheters.

**[VII. Marketing History]{.smallcaps}**

The FX miniRAIL received a CE mark in Europe in December 2001, with
addition of the in-stent restenosis indication in January 2002 and
addition of the 10 mm balloon size in May 2002. The device is available
for commercial sale in the following countries: Austria, Belgium.
Germany, Greece, Hong Kong, Israel, Italy, Malaysia, the Netherlands,
Singapore, Spain, Switzerland, Turkey, and the United Kingdom. The
device has not been withdrawn from any country for reasons relating to
device safety and effectiveness.

**[VIII. Potential Adverse Effects of Device on Health]{.smallcaps}**

Possible adverse effects associated with percutaneous transluminal
coronary angioplasty include, but are not limited to:

-   Coronary vessel dissection, perforation, rupture, or other injury

-   Arrhythmias, including ventricular fibrillation, or other conduction
    disturbances

-   Acute myocardial infarction ("MI")

-   Unstable angina

-   Arteriovenous fistula

-   Coronary artery spasm

-   Total occlusion of the coronary artery

-   Hemorrhage or hematoma

-   Thrombosis

-   Embolism

-   Infection

-   Allergic reaction to medications or contrast media

-   Hypo/hypertension

-   Death

A summary of the adverse events observed in the multi-center IDE study
is provided in tabular form below.

**Summary of Principal Adverse Event Rates Observed in the IDE Study\***

+----------------------+-----------------------+----------------------+
| **Event**            | **Number of Events**  | **% of Patients      |
|                      |                       | (N)**                |
+----------------------+-----------------------+----------------------+
| **Major Adverse      |                       |                      |
| Coronary Events      |                       |                      |
| (MACE)**             |                       |                      |
+----------------------+-----------------------+----------------------+
| > Total MACE         | 7                     | 2.8% (7/248)         |
+----------------------+-----------------------+----------------------+
| > Death              | 0                     | 0% (0/248)           |
+----------------------+-----------------------+----------------------+
| > Q wave MI          | 2                     | 0.8% (2/248)         |
+----------------------+-----------------------+----------------------+
| > Non-Q wave MI\*\*  | 4                     | 1.6% (4/248)         |
+----------------------+-----------------------+----------------------+
| > Target Lesion      | 3                     | 1.2% (3/248)         |
| > Revascularization  |                       |                      |
| > (TLR)              |                       |                      |
+----------------------+-----------------------+----------------------+
| > CABG               | 1                     | 0.4% (1/248)         |
+----------------------+-----------------------+----------------------+
| > PTCA               | 2                     | 0.8% (2/248)         |
+----------------------+-----------------------+----------------------+
| **Non-MACE Major     |                       |                      |
| Cardiovascular       |                       |                      |
| Events**             |                       |                      |
+----------------------+-----------------------+----------------------+
| > Total occlusions   | 2                     | 0.8% (2/248)         |
+----------------------+-----------------------+----------------------+
| > Acute stent        | 1                     | 0.4% (1/263)         |
| > thrombosis (to 24  |                       |                      |
| > hours)             |                       |                      |
+----------------------+-----------------------+----------------------+
| > Sub-acute stent    | 1                     | 0.4% (1/263)         |
| > thrombosis         |                       |                      |
+----------------------+-----------------------+----------------------+
| > Perforations\*\*\* | 2                     | 0.8% (2/263)         |
+----------------------+-----------------------+----------------------+
| > Bleeding/Vascular  | 9                     | 2.0% (5/263)         |
| >                    |                       |                      |
| > c                  |                       |                      |
| omplications\*\*\*\* |                       |                      |
+----------------------+-----------------------+----------------------+
| > Vascular events    | 5                     | 1.2% (3/263)         |
| > requiring          |                       |                      |
| > transfusion        |                       |                      |
+----------------------+-----------------------+----------------------+

\*Except for acute stent thrombosis and bleeding, which are evaluated in
hospital, and perforations, which are evaluated during the procedure,
the adverse event rates reported above are based on the 248 of 263
patients for whom post-discharge follow-up was available through at
least seven days post-procedure.

\*\*Non-Q wave MI is defined as the absence of new pathologic Q waves on
ECG and a total CK of greater than 3 times normal (as defined by the
hospital laboratory) with an elevated MB fraction. If total CK was
unavailable, an MB fraction of greater than 3 times the normal level was
used. Both perforations were iatrogenic, one caused by the guidewire and
the other due to an error in catheter introduction.

\*\*\* Includes hematoma, retroperitoneal bleed, GI bleed, anemia, and
oral bleeding.

In addition to MACE (*i.e.*, death, MI, or TLR), a total of 51 non-MACE
cardiovascular events were observed in 38 patients, along with 28
non-cardiovascular events in 24 patients. Among the non-MACE, the
principal cardiovascular events were ischemia, arrhythmia,
hyper/hypotension, and bleeding/vascular complications. The principal
non-cardiovascular event was pain, primarily back and/or head and neck
pain. No other events occurred in more than 1 % of patients.

None of these events were unanticipated, and the nature and frequency of
events were similar to other PTCA catheters. None of these events was
serious, and the events generally resolved without intervention other
than routine medications (*e.g.*, pain relievers), except for several
cases of bleeding at the insertion site that required transfusion, and
one case of hypotension which required pharmacological treatment.

**[IX. Summary of Preclinical Studies]{.smallcaps}**

Nonclinical testing of the FX miniRAIL was performed in accordance with
FDA's Guidance for the Submission of Research and Marketing Applications
for Interventional Cardiology Devices and relevant industry standards.
The results of these tests are briefly summarized below.

**A. In Vitro Performance Testing**

*[Balloon Rated Burst Pressure]{.underline}*

A total of 519 catheters were tested to establish the rated burst
pressure, including devices of all balloon diameter sizes. Burst testing
was conducted both with an unconstrained balloon (N = 428) and with the
balloon inflated to burst in a simulated vessel (N = 91). A table
summarizing the mean burst pressure, rated burst pressure, and
recommended pressure in atmospheres for each balloon size is included
below. The burst pressure data were analyzed to determine with 95%
confidence that 99.9% of balloons would not burst at or below the
calculated rated burst pressure. All balloon catheters had rated burst
pressures ("RBP") \> 13.0 atm. The specified RBPs in **Table 1** provide
an ample margin of safety relative to the nominal inflation pressure of
8 atm.

**Table 1. Rated Burst Pressure** (atm)

+----------------+---------------+------------------+-----------------+
| **SIZE**       | **Mean**      | **Calculated     | **Recommended** |
|                |               | RBP**            |                 |
|                | **Unc         |                  | **RBP**         |
|                | onstrained/** |                  |                 |
|                |               |                  |                 |
|                | **            |                  |                 |
|                | Constrained** |                  |                 |
+----------------+---------------+------------------+-----------------+
| 2.0 mm         | 24.4/26.1     | 16.7             | 14              |
+----------------+---------------+------------------+-----------------+
| 2.5 mm         | 20.7/23.3     | 14.2             | 13              |
+----------------+---------------+------------------+-----------------+
| 3.0 mm         | 21.6/24.6     | 13.6             | 13              |
+----------------+---------------+------------------+-----------------+
| 3.5 mm         | 22.4/24.4     | 18.6             | 13              |
+----------------+---------------+------------------+-----------------+
| 4.0 mm         | 20.2/23.6     | 13.0             | 12              |
|                |               |                  |                 |
|                |               |                  | [1              |
|                |               |                  | 1]{.underline}2 |
+----------------+---------------+------------------+-----------------+

*[Balloon Fatigue Testing]{.underline}*

Balloon fatigue testing included at least ten catheters from each of the
following sizes: smallest diameter/shortest length, smallest
diameter/longest length, largest diameter/shortest length, largest
diameter/longest length, and ten catheters from each of the other
diameters for a total of 90 test samples. A total of 101 samples were
actually tested due to additional fatigue testing of shelf life samples.
Thirty-eight of the 101 catheters were subjected to a total of 40
fatigue cycles, while the remainder were subjected to the required 20
cycles. The test cycle consisted of inflation to a pressure of 14 atm
with the pressure held at 14 atm for 30 seconds, followed by deflation
to a vacuum state. A .014" guidewire was inserted through the catheter
tip and across the balloon prior to being positioned in a simulated
artery. The catheters were continuously monitored for leakage and
inspected every ten cycles for any visual anomalies. The results met the
acceptance criteria for the test, i.e., 90% or greater pass at the 95%
confidence interval.

*[Balloon Distensibility]{.underline}*

The objective of this test was to evaluate the change in balloon
diameter versus inflation pressure. These tests were conducted on 418
functional, complete, or shortened (to facilitate testing) catheters.
The sizes tested were 30 mm length, all diameters, plus 10 and 15 mm
lengths for the 2.0 mm and 4.0 mm diameters, to establish the compliance
profile. The figure above shows balloon compliance for each balloon size
and indicates the pressure at which the labeled (nominal)
![](media/image1.png){width="5.1875in"
height="2.8958333333333335in"}balloon diameter is attained. These data
are also included in the device labeling.

*[Catheter Preparation/Inflation and Deflation]{.underline}*

Catheter preparation testing was performed on 121 devices in an
environment that simulates use in a coronary artery. Catheters were
subjected to the following test sequence: (1) visual and dimensional
inspection, (2) a preparation and leakage test, and (3) an inflation/
deflation balloon fatigue test. The results of these tests are provided
in **Tables 2, 3 and 4** below.

**Table 2. Balloon Preparation and Leakage**

  ------------------ ------------------ ----------------- ----------------
  **Balloon Size**   **Sample Size**    **Leakage after\  **Purge within\
                                        5 sec?**          5 sec?**

  2.0 mm x 15 mm     30                 No (Pass)         Yes (Pass)

  2.0 mm x 30 mm     30                 No (Pass)         Yes (Pass)

  4.0 mm x 15 mm     30                 No (Pass)         Yes (Pass)

  4.0 mm x 30 mm     31                 No (Pass)         Yes (Pass)
  ------------------ ------------------ ----------------- ----------------

**Table 3. Balloon Inflation/Deflation Performance (3 Cycles)**

+---------------+------------+-----------------+----------------------+
| **Balloon**   | **Sample** | **Inflation in\ | **Deflation in\      |
|               |            | \< 10 sec?**    | \< 20 sec?**         |
| **Size**      | **Size**   |                 |                      |
+---------------+------------+-----------------+----------------------+
| 2.0 mm x 15   | 30         | Yes (Pass)      | Yes (Pass)           |
| mm            |            |                 |                      |
+---------------+------------+-----------------+----------------------+
| 2.0 mm x 30   | 30         | Yes (Pass)      | Yes (Pass)           |
| mm            |            |                 |                      |
+---------------+------------+-----------------+----------------------+
| 4.0 mm x 15   | 30         | Yes (Pass)      | Yes (Pass)           |
| mm            |            |                 |                      |
+---------------+------------+-----------------+----------------------+
| 4.0 mm x 30   | 31         | Yes (Pass)      | Yes (Pass)           |
| mm            |            |                 |                      |
+---------------+------------+-----------------+----------------------+

**Table 4. Visual and Dimensional Inspection**

+--------------+-----------+-----------+-----------------+-----------+
| Visual       | Proximal  | Distal    | Shaft Marker    | Catheter  |
| Inspection   | Shaft     | Shaft     | Locations       | Length    |
|              | Diameter  | Diameter  |                 |           |
|              |           |           | 90 &100cm       | 140cm     |
|              | 2.8F      | 3.1F      |                 |           |
+--------------+-----------+-----------+-----------------+-----------+
| Pass         | Pass      | Pass      | Pass            | Pass      |
+--------------+-----------+-----------+-----------------+-----------+

All samples met the acceptance criteria.

*[Bond Strength]{.underline}*

All bonded and welded joints in the FX miniRAIL were tested following
preconditioning in a 37°C water bath. Fifteen samples of each bond were
tested. All test data exceeded the specification limit for bonded
joints. For the welded joint, the test data exceeded the load cell
capacity of 50 N pull force. Base material broke on all samples.

*[Over-the-Arch Torque Response and Torque Strength]{.underline}*

The objective of these tests was to determine the torque response and
strength of the catheter under two conditions: (1) when its distal tip
was free to rotate, and (2) when its distal tip was fixed. The catheter
was inserted into a test fixture, which consists of a simulated aortic
arch and coronary artery. Fifteen catheters were included in each test.
In the first test condition, the proximal end was rotated with the
distal tip unconstrained until failure occurred. The number of rotations
to failure and the mode of failure for each sample tested were recorded.
All test units were able to maintain functionality after two complete
rotations.

In the second test condition, a torque strength test was performed to
determine the ability of the FX miniRAIL Catheter to withstand extreme
torque under simulated use conditions "over-the-arch" when the tip of
the catheter is not free to rotate and either the shaft or the inflation
luer fitting is rotated (which is not likely to happen in the clinical
setting). Fifteen catheters were tested. The results demonstrated that
the inflation/deflation function of the FX miniRAIL is not impaired
after five complete rotations of the inflation lumen.

*[Radiodetectability]{.underline}*

Evaluation of five FX miniRAIL Catheters compared to two commercially
available catheters demonstrated comparable radio detectability on
fluoroscopy in a porcine model.

*[Corrosion]{.underline}*

Corrosion resistance of the catheter was conducted in accordance with
standard methods for evaluation of balloon dilatation catheters (ISO
10555-1). A total of 15 catheters were evaluated. The results
demonstrated no corrosion of any of the metal parts, including the
radiopaque marker bands, the hypotube, and the pull wire.

**B. Biocompatibility Testing**

The objective of these tests was to establish the Biocompatibility of
the FX miniRAIL™ Catheter. Testing was conducted consistent with the
requirements of FDA Program Memorandum #G95-1 (Use of International
Standard ISO-10993, "Biological Evaluation of Medical Devices part 1:
Evaluation and Testing") and ISO 10993, Biological Evaluation of Medical
Devices Part 1: Evaluation and Testing, for externally communicating
devices that contact circulating blood for a limited duration (\< 24
hours). These tests included cytotoxicity, sensitization,
irritation/intracutaneous reactivity, acute systemic toxicity,
hemocompatibility (hemolysis, thrombogenicity, thromboresistance, and
complement activation), and pyrogenicity. No significant adverse
findings were noted.

**C. Shelf Life, Packaging, and Sterilization Testing**

The objective of these tests was to establish a 24-month shelf life for
the FX miniRAIL Catheter in its final package. Following sterilization
and extreme conditioning (thermal cycling), finished devices were
exposed to accelerated aging, shipping simulation testing similar to the
original verification, and validation testing. Product packaging was
subjected to integrity tests, which at the 24-month time frame included
seal pull and bubble emission tests, while the finished catheters were
subjected to functional tests including balloon compliance, burst,
function, and performance. The results met all acceptance criteria.

The FX miniRAIL is sterilized using ethylene oxide ("EtO") according to
parameters that have been validated to produce a sterility assurance
level of at least 10^-6^. Residuals are within acceptable limits.

**D. Animal Testing (In Vivo)**

Animal testing was conducted in two phases. Following preliminary
prototype evaluation, testing of the final device configuration in a
porcine model was performed. Catheter insertion was randomized to LAD
and circumflex ("LCX") arteries in five pigs, with balloon inflation
controlled by on-line quantitative coronary angiography (QCA) to a
balloon artery ratio of 1.0 : 1.2. Histopathology examination was
performed at an independent laboratory. No adverse events or clinically
significant histopathology findings were noted.

Based on the examination of over 235 tissue samples and on angiography
analysis, the study concluded that there was no evidence of perforation
or laceration in either group and that the degree of injury resulting
from passage and inflation of the FX miniRAIL Catheter was similar to
or less than a standard PTCA catheter.

**X. [Summary of Clinical Studies]{.smallcaps}**

A multi-center, non-randomized, single-arm prospective clinical trial
was conducted to evaluate the safety and effectiveness of the FX
miniRAIL Catheter in patients with single or multiple vessel coronary
artery disease who were scheduled to undergo percutaneous coronary
intervention because of symptoms of stable or unstable angina pectoris.
Twelve sites entered a total of 263 patients (366 lesions) eligible for
elective coronary angioplasty who met the inclusion/exclusion criteria.
The hypothesis of the study was that the procedural success rate and
clinical success rate for the FX miniRAIL, as defined below, were
equivalent to objective performance criteria based on contemporary
published literature.

**Eligibility Criteria**

Principal inclusion criteria for the study were as follows: (1) single
or multiple vessel coronary artery disease in subjects who are scheduled
to undergo percutaneous coronary intervention because of symptoms of
stable or unstable angina pectoris; (2) stenotic lesions in native
coronary arteries, including in-stent restenosis; (3) lesions with a
reference vessel diameter ("RVD") of between 2.0 mm and 4.0 mm.
Principal exclusions were as follows: left ventricular ejection fraction
\< 35%; contraindication to CABG, antiplatelet and/or anticoagulation
medications; severe renal failure with creatinine [\>]{.underline}
2mg/dL; pregnancy; symptoms of cardiogenic shock; acute myocardial
infarction or an MI within the past three days, and/or elevated CPK at
the time of enrollment; totally obstructed coronary arteries (TIMI 0 or
1 flow); lesions longer than 30 mm; visible thrombus in angiography; an
"unprotected" left main coronary artery (\> 50% diameter stenosis);
requiring treatment of more than three lesions or more than two vessels;
coronary spasm in the absence of a significant stenosis; severe
calcification by visual assessment; requiring treatment with
atherectomy; and lesions in surgical conduits --- saphenous vein grafts,
internal mammary arteries, or radial arteries. Patients who underwent a
staged procedure 30 days prior to enrollment and/or were scheduled to
have a staged procedure 14 days after treatment with the FX miniRAIL
were also excluded from participation.

**Methods**

The primary endpoints for the study were procedural success and clinical
success. Procedural success was defined as \<50% final diameter stenosis
in at least one of the FX-attempted lesions without death, Q wave or
non-Q wave MI, or emergency CABG during hospital stay. Clinical success
was defined as freedom from MACE, defined as death, any MI (Q wave or
non-Q wave), or target lesion revascularization (TLR) at 14-day
follow-up. Coronary angiography, consistent with QCA standards, was
performed before and immediately after angioplasty with the FX
miniRAILTM Catheter. Stenosis resolution was measured by on-line QCA.
The initial, post-FX, and final lesion status were assessed both by
on-line and off-line QCA, measuring percentage of diameter stenosis,
percentage of area stenosis, post-FX minimal luminal diameter, and mean
reference diameter. Other balloon/procedure data, such as stenosis
resolution pressure and inflation time, also were collected.
Intravascular ultrasound ("IVUS") examination was also performed on a
subset of 55 patients to evaluate the effect of the device on the
vascular lumen. All major adverse clinical events were source documented
and adjudicated by an independent clinical events committee (CEC).

**Baseline Characteristics**

Of the 263 patients treated, 12 were enrolled in the roll-in phase and
251 were enrolled in the pivotal or registry phase of the study. Results
are reported below principally for the 251 patients enrolled in the
registry phase, although no significant differences in procedural
success or clinical success were noted between the roll-in and registry
cases. Baseline demographics and clinical characteristics showed a mean
age of 63.8 ± 10.5 years, with 73.3% (184/251) male participants and
32.3% (81/251) with a history of diabetes mellitus. The principal
baseline characteristics of the study population are summarized in
**Table 5** below.

**Table 5. Summary of Patient Baseline Characteristics**

+----------------------------------------------+-----------------------+
| **Patient Characteristics**                  | **Aggregate**         |
+----------------------------------------------+-----------------------+
| > Age                                        |                       |
+----------------------------------------------+-----------------------+
| > Mean + SD (n)                              | 63.8+/- 10.5 (251)    |
+----------------------------------------------+-----------------------+
| > Range (min, max)                           | (35, 88)              |
+----------------------------------------------+-----------------------+
| > Gender: Male                               | 73.3% (184/251)       |
+----------------------------------------------+-----------------------+
| > Current Smoker                             | 15.1% (38/251)        |
+----------------------------------------------+-----------------------+
| > Diabetes                                   | 32.3% (81/251)        |
+----------------------------------------------+-----------------------+
| > History of Hypertension                    | 72.9% (183/251)       |
+----------------------------------------------+-----------------------+
| > History of Hypercholesterolemia            | 72.9% (183/251)       |
+----------------------------------------------+-----------------------+
| > Prior MI                                   | 40.2% (101/251)       |
+----------------------------------------------+-----------------------+
| > Prior CABG                                 | 16.7% (42/251)        |
+----------------------------------------------+-----------------------+
| > Prior PTCA                                 | 58.6% (147/251)       |
+----------------------------------------------+-----------------------+
| > Angina                                     | 84.9% (213/251)       |
+----------------------------------------------+-----------------------+
| > Stable Angina                              | 52.2% (131/251)       |
+----------------------------------------------+-----------------------+
| > Unstable Angina                            | 32.7% (82/251)        |
+----------------------------------------------+-----------------------+
| > Canadian Cardiovascular Society (CCS)      | 39.0% (98/251)        |
| > Angina Class III/IV                        |                       |
+----------------------------------------------+-----------------------+
| > Ejection Fraction:                         | 78.4% (192/245)       |
| >                                            |                       |
| > Normal (\> 50%)                            | 20.0% (49/245)        |
| >                                            |                       |
| > 35-50%                                     | 1.6% (4/245)          |
| >                                            |                       |
| > \< 35%                                     |                       |
+----------------------------------------------+-----------------------+

+----------------------------------------------+-----------------------+
| **Pre-procedure Medication**                 |                       |
+----------------------------------------------+-----------------------+
| > Aspirin                                    | 94.0% (236/251)       |
+----------------------------------------------+-----------------------+
| > Plavix                                     | 51.6% (129/250)       |
+----------------------------------------------+-----------------------+
| > Ticlid                                     | 0.4% (1/249)          |
+----------------------------------------------+-----------------------+

Baseline lesion characteristics based on QCA assessment are summarized
in **Table 6** below.

**Table 6. Baseline Lesion Characteristics^\*^**

+------------------------------+-----------------+---------------------+
| **Patient Characteristics**  | **Aggregate**   | **95% Confidence    |
|                              |                 | Interval**          |
+------------------------------+-----------------+---------------------+
| > Vessel Diameter\*\* (mm)   |                 |                     |
+------------------------------+-----------------+---------------------+
| > Mean + SD (n)              | 2.80 +/- 0.49   | (2.74, 2.85)        |
|                              | (319)           |                     |
+------------------------------+-----------------+---------------------+
| > Range (min, max)           | (1.61, 4.57)    |                     |
+------------------------------+-----------------+---------------------+
| > Minimum Lumen Diameter     |                 |                     |
| > \*\*(mm)                   |                 |                     |
+------------------------------+-----------------+---------------------+
| > Mean + SD (n)              | 0.92 +/- 0.40   | (0.87, 0.96)        |
|                              | (320)           |                     |
+------------------------------+-----------------+---------------------+
| > Range (min, max)           | (0.00, 2.10)    |                     |
+------------------------------+-----------------+---------------------+
| > Diameter Stenosis %        |                 |                     |
+------------------------------+-----------------+---------------------+
| > Mean + SD (n)              | 67.36 +/- 12.81 | (65.95, 68.77)      |
|                              | (319)           |                     |
+------------------------------+-----------------+---------------------+
| > Range (min, max)           | (29.32, 100.00) |                     |
+------------------------------+-----------------+---------------------+
| > Lesion Length              |                 |                     |
+------------------------------+-----------------+---------------------+
| > Mean + SD (n)              | 12.69 +/- 7.15  | (11.90, 13.48)      |
|                              | (317)           |                     |
+------------------------------+-----------------+---------------------+
| > Range (min, max)           | (2.00, 60.28)   |                     |
+------------------------------+-----------------+---------------------+
| > Lesion Vessel              |                 |                     |
+------------------------------+-----------------+---------------------+
| > RCA                        | 29.0% (93/321)  | (24.1%, 34.3%)      |
+------------------------------+-----------------+---------------------+
| > LAD                        | 38.0% (122/321) | (32.7%, 43.6%)      |
+------------------------------+-----------------+---------------------+
| > Circumflex                 | 31.8% (102/321) | (26.7%, 37.2%)      |
+------------------------------+-----------------+---------------------+
| > SVG\*\*                    | 1.2% (4/321)    | (0.3%, 3.2%)        |
+------------------------------+-----------------+---------------------+
| > Calcification:             | 8.8% (28/320)   | (5.9%, 12.4%)       |
| > Moderate/Severe            |                 |                     |
+------------------------------+-----------------+---------------------+
| > Thrombus\*\*               | 2.2% (7/320)    | (0.9%, 4.5%)        |
+------------------------------+-----------------+---------------------+
| > Eccentric Lesion           | 28.1% (90/320)  | (23.3%, 33.4%)      |
+------------------------------+-----------------+---------------------+
| > Angulation \> 45 degrees   | 5.6% (18/320)   | (3.4%, 8.7%)        |
+------------------------------+-----------------+---------------------+
| > ACC/AHA Lesion Class       |                 |                     |
+------------------------------+-----------------+---------------------+
| > MACC Score A               | 11.8% (38/321)  | (8.5%, 15.9%)       |
+------------------------------+-----------------+---------------------+
| > MACC Score B1              | 44.5% (143/321) | (39.0%, 50.2%)      |
+------------------------------+-----------------+---------------------+
| > MACC Score B2              | 32.4% (104/321) | (27.3%, 37.8%)      |
+------------------------------+-----------------+---------------------+
| > MACC Score C               | 0.0% (0/321)    | (0.0%, 1.1%)        |
+------------------------------+-----------------+---------------------+
| > Total Occlusions           | 1.2% (4/321)    | (0.3%, 3.2%)        |
| > Treated\*\*                |                 |                     |
+------------------------------+-----------------+---------------------+

\*Baseline characteristics are reported for a total of 321 of the 349
intention-to-treat FX miniRAIL lesions (in 251 registry patients) for
which baseline QCA was available.

\*\*In some instances, patients who were included based on visual
examination were found upon QCA to present lesions that were slightly
outside the eligibility criteria, *e.g.*, due to diameter, vessel type,
length, presence of thrombus, or total occlusion. However, because
eligibility was determined based on visual examination, these were not
regarded as protocol deviations.

**Results**

Data analysis was performed on an intent-to-treat basis. With respect to
procedural success, all 251 registry patients were included in the
analysis, except for three patients for whom QCA data were not available
to permit evaluation of residual stenosis. Among this group of 248
patients, the procedural success rate was 94.8% (235/248). With respect
to clinical success, which required post-discharge follow-up for
evaluation of non-acute MACE (*i.e.*, death, MI, or TLR), the analysis
included the 238 patients in the pivotal phase of the study for whom at
least a seven-day follow-up post-procedure was available. Among this
group, the clinical success rate was 97.1% (231/238).

**Table 7. Summary of Primary Endpoints**

+--------------------+-----------------------+------------------------+
| **Effectiveness\   | **Aggregate**         | **95% Confidence       |
| Measures**         |                       | Interval**             |
+--------------------+-----------------------+------------------------+
| > Procedural       | 94.8% (235/248)       | (91.2%, 97.2%)         |
| > Success\         |                       |                        |
| > (In-hospital)    |                       |                        |
+--------------------+-----------------------+------------------------+
| > Clinical Success | 97.1% (231/238)       | (94.0%, 98.8%)         |
+--------------------+-----------------------+------------------------+

These rates met the study hypothesis, *i.e.*, of observed procedural
success no less than the historical rate of 92% (OPC) ± 7% (delta), and
of observed clinical success (MACE-free at the post-discharge follow-up
visit) no less than the historical rate of 95% (OPC) ± 7% (delta). In
both cases, the aggregate value exceeds the objective performance
criterion that was established based on the historical literature, and
the lower limits of the confidence intervals with respect to each
endpoint are well above the minimum required to demonstrate equivalence.

Further analysis of the components of each of the primary endpoints is
provided in **Table 8** below.

**Table 8. Analysis of Components of Primary Endpoints**

+-----------------------------------+-----------------+----------------+
| **Effectiveness Measures**        | **Aggregate**   | **95%          |
|                                   |                 | Confidence**   |
|                                   |                 |                |
|                                   |                 | **Interval**   |
+-----------------------------------+-----------------+----------------+
| > Procedural Success              | 94.8% (235/248) | (91.2%, 97.2%) |
+-----------------------------------+-----------------+----------------+
| > \> 50% residual diameter        | 2.8% (7/248)    | (1.1%, 5.7%)   |
| > stenosis                        |                 |                |
+-----------------------------------+-----------------+----------------+
| > In-hospital Death               | 0.0% (0/251)    | (0.0%, 1.5%)   |
+-----------------------------------+-----------------+----------------+
| > In-hospital MI (Q wave or non-Q | 2.0% (5/251)    | (0.7%, 4.6%)   |
| > wave)                           |                 |                |
+-----------------------------------+-----------------+----------------+
| > Emergent CABG                   | 0.4% (1/251)    | (0.2%, 3.5%)   |
+-----------------------------------+-----------------+----------------+
| > Clinical Success                | 97.1% (231/238) | (94.0%, 98.8%) |
+-----------------------------------+-----------------+----------------+
| > Death (at post-discharge        | 0.0% (0/238)    | (0.0%, 1.6%)   |
| > follow-up)                      |                 |                |
+-----------------------------------+-----------------+----------------+
| > MI (at post-discharge           | 2.5% (6/238)    | (1.0%, 5.8%)   |
| > follow-up)                      |                 |                |
+-----------------------------------+-----------------+----------------+
| > Q wave MI                       | 0.8% (2/238)    | (0.1%, 3.2%)   |
+-----------------------------------+-----------------+----------------+
| > Non-Q wave MI                   | 1.7% (4/238)    | (0.5%, 4.5%)   |
+-----------------------------------+-----------------+----------------+
| > TLR                             | 1.3% (3/238)    | (0.3%, 3.6%)   |
+-----------------------------------+-----------------+----------------+

Of the 13/248 patients who were not procedural successes, six failed due
to in-hospital MACE, and seven failed due to residual stenosis \> 50%.
As illustrated in **Table 9** below, among the 238 patients who returned
for follow-up at least seven days post-procedure, seven experienced
MACE. Six of the patients experienced MACE while in the hospital, and
one experienced MACE (a non-Q wave MI related to a subsequent non-target
lesion revascularization, not to the FX miniRAIL) outside the hospital
at eight days post-procedure. MACE rates were calculated per patient;
thus, while several of the patients experienced more than one MACE, each
patient was counted only once. In total, there were nine events among
these seven patients (four non-Q wave MI, two Q wave MI, and three TLR).

**Table 9. Combined (In-Hospital and Post-Discharge) Complications\***

+-----------------------------------------+-------------+--------------+
| **Event**                               | **% (N)**   | **95% C.I.** |
+-----------------------------------------+-------------+--------------+
| > MACE (Death, MI, TLR)                 | 2.9%        | (1.2%, 6.0%) |
|                                         | (7/238)     |              |
+-----------------------------------------+-------------+--------------+
| > Death                                 | 0.0%        | (0.0%, 1.5%) |
|                                         | (0/238)     |              |
+-----------------------------------------+-------------+--------------+
| > Cardiac Death                         | 0.0%        | (0.0%, 1.5%) |
|                                         | (0/238)     |              |
+-----------------------------------------+-------------+--------------+
| > Non Cardiac Death                     | 0.0%        | (0.0%, 1.5%) |
|                                         | (0/238)     |              |
+-----------------------------------------+-------------+--------------+
| > MI                                    | 2.5%        | (0.9%, 5.4%) |
|                                         | (6/238)     |              |
+-----------------------------------------+-------------+--------------+
| > Q wave MI                             | 0.8%        | (0.1%, 3.0%) |
|                                         | (2/238)     |              |
+-----------------------------------------+-------------+--------------+
| > Non-Q wave MI                         | 1.7%        | (0.5%, 4.2%) |
|                                         | (4/238)     |              |
+-----------------------------------------+-------------+--------------+
| > Target Lesion Revascularization       | 1.3%        | (0.3%, 3.6%) |
|                                         | (3/238)     |              |
+-----------------------------------------+-------------+--------------+
| > PTCA                                  | 0.8%        | (0.1%, 3.0%) |
|                                         | (2/238)     |              |
+-----------------------------------------+-------------+--------------+
| > CABG                                  | 0.4%        | (0.0%, 2.3%) |
|                                         | (1/238)     |              |
+-----------------------------------------+-------------+--------------+
| > Target Vessel Revascularization       | 1.3%        | (0.3%, 3.6%) |
|                                         | (3/238)     |              |
+-----------------------------------------+-------------+--------------+
| > PTCA                                  | 0.8% (2/238 | (0.1%, 3.0%) |
|                                         | )           |              |
+-----------------------------------------+-------------+--------------+
| > CABG                                  | 0.4%        | (0.0%, 2.3%) |
|                                         | (1/238)     |              |
+-----------------------------------------+-------------+--------------+
| > Total Occlusions                      | 0.8%        | (0.1%, 3.0%) |
|                                         | (2/238)     |              |
+-----------------------------------------+-------------+--------------+

\*Because assessment of out-of-hospital events required post-discharge
follow-up, these variables are reported for the 238 of 251 registry
patients for whom post-discharge follow-up of at least seven days was
completed.

With regard to other measures of device safety, the rate and type of
dissections observed upon angiography after use of the FX miniRAIL was
consistent with other PTCA investigations. Only two perforations were
observed in the investigation, neither of which was determined to be due
to the FX miniRAIL. Additional evidence of the safety of the device is
available from IVUS examination of the lesions, which was performed in a
subset of 55 lesions in 42 patients at two investigational sites. The
results of this supplementary analysis also demonstrated that the type
and rate of dissections were similar to other PTCA catheters. A total of
12 failures to cross the target lesion were observed that were deemed to
be device-related, including two device malfunctions, three instances of
"melon seeding, " and seven cases in which the device was unable to
cross the target lesion, but another catheter subsequently crossed the
lesion. There were also three failures to cross the lesion not related
to the study device (*e.g.*, cases where no device was able to cross, or
other procedural issues).

Further analysis of the data for the 77 patients with only in-stent
restenosis ("ISR") lesions compared to the 160 patients with only
non-ISR lesions demonstrated no significant differences in either
procedural success rates or clinical success rates based on lesion type.
These results are summarized in the table below.

**Table 10. Comparison of Outcomes in Patients with ISR versus non-ISR
Lesions\***

+-----------------------------+--------------+---------------+--------+
|                             | **ISR**      | **Non-ISR**   | **p-v  |
|                             |              |               | alue** |
+-----------------------------+--------------+---------------+--------+
| > Clinical Success          | 97.2%0       | 97.4%         | 1.00   |
|                             | (70/72)      | (148/152)     |        |
+-----------------------------+--------------+---------------+--------+
| > Procedural Success        | 92.1%        | 96.8%         | 0.18   |
|                             | (70/76)      | (153/158)     |        |
+-----------------------------+--------------+---------------+--------+
| > MACE                      | 2.8%(2/72)   | 2.6% (4/152)  | 1.00   |
+-----------------------------+--------------+---------------+--------+
| > In-Hospital MACE          | 2.6%(2/77)   | 1.9% (3/160)  | 0.66   |
+-----------------------------+--------------+---------------+--------+
| > Out-of-Hospital MACE      | 0.0%(0/72)   | 0.7% (1/152)  | 1.00   |
+-----------------------------+--------------+---------------+--------+
| > Death                     | 0.0%(0/72)   | 0.0% (0/152)  | N/A    |
+-----------------------------+--------------+---------------+--------+
| > MI                        | 2.8%(2/72)   | 2.0% (3/152)  | 0.66   |
+-----------------------------+--------------+---------------+--------+
| > Q wave MI                 | 2.8%(2/72)   | 0.0% (0/152)  | 0.10   |
+-----------------------------+--------------+---------------+--------+
| > Non-Q wave MI             | 0.0%(0/72)   | 2.0% (3/152)  | 0.55   |
+-----------------------------+--------------+---------------+--------+
| > TLR                       | 1.4% (1/72)  | 0.7% (1/152)  | 0.54   |
+-----------------------------+--------------+---------------+--------+
| > Total Occlusions (at      | 1.4%(1/72)   | 0.0% (0/152)  | 0.31   |
| > post-discharge follow-up) |              |               |        |
+-----------------------------+--------------+---------------+--------+
| > Acute Stent Thrombosis    | 0.0% (0/77)  | 0.0% (0/160)  | N/A    |
| > (to 24 hours)             | \*           |               |        |
+-----------------------------+--------------+---------------+--------+

\* There were 72 ISR cases with sufficient post-procedure follow-up for
evaluation of clinical success: 76 with in‑hospital data up to
discharge; and 77 with 24-hour in-hospital data.

\*\* Patients with both ISR and non-ISR lesions were excluded.

Multivariate analysis also indicated that gender, diabetes, and
investigational site did not significantly impact outcomes.

The additional procedural data that were collected demonstrated a mean
stenosis resolution pressure of 6.14 +/- 2.51 atm, and a mean maximum
inflation pressure of 8.49 +/- 2.90 atm, which is well below the rated
burst pressure for the device.

In addition to the IDE study described above, a 30-patient registry
study was conducted at a single center in Germany in 2001 to support CE
marking of the device. The eligibility criteria and methods used in this
study were generally similar to the IDE study described above. The
primary endpoints also were similar, although the definitions of
procedural success and clinical success differed slightly (*e.g.*, MACE
collected through 30 days, defined to include Q wave MI but not non-Q
wave MI). However, the results were consistent with the IDE study, with
procedural and clinical success rates of 100%. Commercial experience
with the FX miniRAIL in Europe since receipt of the CE mark further
supports the safety and efficacy of the device.

**[XI. Conclusions Drawn from Studies]{.smallcaps}**

The results of the pivotal IDE study described above demonstrate that
the FX miniRAIL^TM^ is reasonably safe and effective for use in PTCA
procedures. The procedural success and clinical success rates that were
observed in this investigation are equivalent to those reported in
similar historical studies of other PTCA catheters that have been
published in the medical literature. The rate and type of MACE also are
similar to those associated with other PTCA catheters. The use of a wire
external to the device and the resultant reduced crossing profile,
permitted effective lesion dilatation, and did not result in any
observed increase in MACE rates or perforations/dissections. The study
also demonstrates that the FX miniRAIL can be used in either ISR or *de
novo* lesions with similar safety and effectiveness. These results were
confirmed by a separate single-center investigation conducted in Europe
and supported by subsequent commercial experience. Thus, the device is
reasonably safe and effective for its intended use.

### XII. PANEL RECOMMENDATION

In accordance with the provisions of section 515(c)(2) of the act as
amended by the Safe Medical Devices Act of 1990, this PMA was not
referred to the Circulatory Systems Devices Panel, an FDA advisory
committee, for review and recommendation because the information in the
PMA substantially duplicates information previously reviewed by the
panel.

### XIII. FDA DECISION

The applicant's manufacturing facilities were inspected on 4/9/02 and
12/20/02 and found to be in compliance with the Quality System
Regulation (21 CFR Part 820). FDA issued a PMA approval order to X
Technologies, Inc. on June 11, 2003.

### XIV. APPROVED SPECIFICATIONS

**Direction for use:** See Device Labeling

> **Hazards to Health from Use of the Device:** See Indications,
> Contraindications, Warnings, and Precautions, and Adverse Events in
> the Final Draft Labeling, Indication for Use.
>
> **Post-approval Requirements and Restrictions:** See Approval Order.