![](media/image1.wmf){width="2.8229166666666665in"
height="0.34930555555555554in"}INSTRUCTIONS FOR USE

**EMBOL-X AORTIC FILTER**

# 

# 1. DESCRIPTION

> The EMBOL•X Aortic Filter consists of three primary components: a
> distal filter or basket assembly to capture and retain particulate
> emboli (positioned within the aorta); a locking cartridge for
> attachment through the EMBOL•X Aortic Cannula sideport and to ensure
> correct orientation of the filter during use; and a proximal
> syringe-like plunger mechanism to deliver and withdraw the basket into
> and from the aorta. The distal filter consists of a heparin‑coated
> mesh filter mounted on a frame.

######### Diagram 1: EMBOL•X Aortic Filter

![](media/image3.png){width="0.5409722222222222in"
height="0.10416666666666667in"}

![](media/image4.png)

> The EMBOL•X Aortic Filter is provided in a cartridge that locks into
> the Introducer port of the EMBOL•X Aortic Cannula in a fixed position
> to ensure proper orientation of the Filter when it is inserted into
> the aorta. The Filter is inserted through the Introducer port by
> depressing its syringe-like plunger mechanism. The self-venting knob
> allows the air in the cartridge to automatically vent when the
> cartridge is inserted into the cannula and contacts blood. On
> insertion, the Filter opens to fill the diameter of the ascending
> aorta. A marker band (optional) on the plunger shaft, when aligned
> with the Filter Cartridge handle, indicates that the Filter is exiting
> the Introducer port and is about to enter the aorta. The Filter is
> withdrawn by pulling up on the plunger.

######### 

######### Diagram 2: EMBOL•X Aortic Filter connected with EMBOL•X Aortic Cannula

# 2. INDICATIONS AND INTENDED USE

> The EMBOL•X Aortic Filter is indicated for use with the EMBOL•X Aortic
> Cannula in cardiac surgery procedures to contain and remove
> particulate emboli.

# 3. CONTRAINDICATIONS

> The EMBOL•X Aortic Filter is contraindicated for use in patients with:

-   Aneurysm of the ascending aorta

-   Aortic trauma

# 4. WARNINGS

-   Do not manipulate or reposition the EMBOL•X Aortic Cannula or the
    EMBOL•X Aortic Filter shaft with the filter deployed. If the cannula
    must be repositioned, first retract the Filter. Failure to do so may
    cause injury to the aorta.

-   Hold the base of the Introducer port of EMBOL•X Aortic Cannula while
    inserting the EMBOL•X Aortic Filter. Failure to do so may cause
    injury to the aorta.

-   Do not deploy the EMBOL•X Aortic Filter if excessive resistance is
    felt. Attempting to deploy the EMBOL•X Aortic Filter when resistance
    is felt may indicate improper positioning of the cannula. Forcing
    deployment may cause injury to the aorta.

-   Failure to remove all air from the EMBOL•X Aortic Filter may result
    in air embolism.

-   The EMBOL•X Aortic Filter must be retracted and removed from the
    EMBOL•X Aortic Cannula Introducer port prior to routine
    administration of protamine for heparin reversal, since the Filter
    is heparin-coated. Failure to do so may result in thrombus formation
    on the Filter.

-   Do not use a single EMBOL•X Aortic Filter more than once. This may
    result in:

```{=html}
<!-- -->
```
-   Air embolism, since the porous plug on the Filter plunger will vent
    only once.

-   Increased risk of thrombus formation, which may make the Filter
    difficult to insert or remove.

-   Distortion of the Filter frame.

```{=html}
<!-- -->
```
-   Although the EMBOL•X Aortic Cannula may be used separately in place
    of a standard arterial return cannula, the EMBOL•X Aortic Filter
    must be used in conjunction with the EMBOL•X Aortic Cannula.

-   Ensure that the cross-clamp is positioned at least 2.0 cm away from
    the EMBOL•X Aortic Cannula. Failure to do so may result in
    difficulty with insertion and/or removal of the Filter.

-   Do not use a single EMBOL•X Aortic Filter intra-aortically for more
    than **60** (sixty) minutes.

-   If resistance is met while retracting the EMBOL•X Aortic Filter into
    the cartridge, leave the Filter in place until the EMBOL•X Aortic
    Cannula can be removed with the Filter deployed, using standard
    decannulation techniques.

# 5. PRECAUTIONS

-   CAUTION: Federal (US) Law restricts this device to sale by or on the
    order of a physician.

-   Supplied sterile and non-pyrogenic in undamaged package. For single
    use only. Do not resterilize or reuse. Resterilization may cause
    damage to the device and subsequent patient injury.

-   Do not use device if the package sterile integrity appears
    jeopardized or is opened or damaged.

-   Note "Use Before" or "Use By" date prior to use. Do not use past the
    allowable date.

```{=html}
<!-- -->
```
-   The EMBOL•X Aortic Filter and any other accompanying device should
    only be used in an operating room completely equipped for
    conventional cardiac surgery and by a surgeon trained in cardiac
    surgery.

```{=html}
<!-- -->
```
-   Proper surgical procedures and techniques are the responsibility of
    the medical professional. The described instructions provided are
    for information purposes only. Each surgeon must evaluate the
    appropriateness of the procedure based on his/her own medical
    training, experience, type of surgical procedure, and patient
    condition.

-   Do not expose the device to organic solvents, ionizing radiation,
    ultraviolet light, or alcohol-based fluids. The housing may weaken
    or crack and subsequent use may result in patient injury.

**6. OBSERVED ADVERSE EVENTS**

Twelve hundred eighty-nine (1289) patients were enrolled at twenty-two
(22) centers in the ICEM 2000 clinical trial for primary CABG or primary
valve surgical procedures. Of these, 645 patients were randomized to the
EMBOL•X Aortic Filter (Treatment), and 644 patients were randomized to
not receive the Aortic Filter (Control). Major adverse events reported
during the trial are shown in Table 1.

> **[Table 1:]{.underline} Major Adverse Event Summary**
>
> Number (%)

+-------------------------------------+----------------+---------------+
| ######### Event                     | **Treatment**  | **Control**   |
|                                     |                |               |
|                                     | **(N=645)**    | **(N=644)**   |
+-------------------------------------+----------------+---------------+
| Limb ischemia                       | 3 (0.5)        | 3 (0.5)       |
+-------------------------------------+----------------+---------------+
| Gastrointestinal complications      | 5 (0.8)        | 5 (0.8)       |
+-------------------------------------+----------------+---------------+
| Death                               | 10 (1.6)       | 11 (1.7)      |
+-------------------------------------+----------------+---------------+
| Neurologic deficit                  | 18 (2.8)       | 18 (2.8)      |
+-------------------------------------+----------------+---------------+
| Renal insufficiency                 | 40 (6.2)       | 52 (8.1)      |
+-------------------------------------+----------------+---------------+
| Myocardial infarction               | 67 (10.4)      | 64 (9.9)      |
+-------------------------------------+----------------+---------------+
| Any event                           | 110 (17.1)     | 122 (18.9)    |
+-------------------------------------+----------------+---------------+

> POTENTIAL ADVERSE EVENTS
>
> The potential adverse events associated with the use of the EMBOL•X
> Aortic Filter (as with other invasive cardiac surgery devices)
> include, but are not limited to, the following (in alphabetical
> order):

+-------------------------------------+--------------------------------+
| -   Allergic reaction               | -   Gastrointestinal           |
|                                     |     complications              |
| -   Angina                          |                                |
|                                     | ```{=html}                     |
| -   ARDS                            | <!-- -->                       |
|                                     | ```                            |
| -   Atrial / Ventricular arrhythmia | -   Heart block                |
|                                     |                                |
| -   Bleeding requiring transfusion  | -   Hemothorax / Pneumothorax  |
|                                     |                                |
| -   Cardiac arrest                  | -   Hepatic failure            |
|                                     |                                |
| -   Cardiac tamponade               | -   Limb ischemia              |
|                                     |                                |
| -   Coagulopathy                    | -   Metabolic coma             |
|                                     |                                |
| -   Death                           | -   Myocardial infarction      |
|                                     |                                |
| -   Delirium                        | -   Pneumonia                  |
|                                     |                                |
| -   Dissection of aortic wall       | -   Prolonged ventilation      |
|                                     |                                |
| -   Embolism                        | -   Renal insufficiency        |
|                                     |                                |
| -   Endocarditis / Pericarditis     | -   RIND / TIA / Stroke        |
|                                     |                                |
| -   Endothelial disruption of       | -   Septicemia                 |
|     aortic wall                     |                                |
|                                     | -   Shock                      |
|                                     |                                |
|                                     | -   Sternal infection          |
|                                     |                                |
|                                     | -   Visual impairment          |
+-------------------------------------+--------------------------------+

### 7. CLINICAL STUDY

> *Study Design*

####### The EMBOL•X ICEM 2000 trial was a prospective, multi-center, 1:1 randomized, controlled study to demonstrate the safety and effectiveness of the EMBOL•X Aortic Filter (and the associated EMBOL•X Aortic Cannula) in capturing particulate emboli during first-time non-emergent coronary artery bypass graft (CABG) or aortic/mitral valve repair/replacement procedures utilizing cardiopulmonary bypass. The study was conducted at conducted at 22 sites, and was comprised of 1289 randomized patients, of which 645 were randomized to the EMBOL•X Aortic Filter (Treatment arm) and 644 were randomized to not receive the Aortic Filter (Control).

> *Primary Endpoints*

The primary safety hypothesis is that of equivalence between a composite
perioperative complication rate for patients undergoing cardiac surgery
using the EMBOL•X Aortic Filter (Treatment) as compared to the current
CPB cardiac surgery practice of using no Aortic Filter (Control). The
primary safety composite endpoint was comprised of the following
post-operative clinical events, measured from the time of randomization
(the operation) through hospital discharge or 30 days, whichever
occurred first: Neurologic deficit (mild and severe); Renal
insufficiency (with and without dialysis); Gastrointestinal (GI)
complications; Perioperative Myocardial Infarction (MI);
Limb-threatening peripheral embolism (Limb Ischemia); and Death. The
primary effectiveness endpoint was the capture of particulate emboli by
the filter (Treatment arm only) in at least 75% of the filtered
patients, with particulate debris visually confirmed by light
microscopy.

####### *Patients Studied*

####### The patient population of this study was limited to patients undergoing first time, non-emergent Coronary Artery Bypass Grafting (CABG), aortic valve replacement or mitral valve repair or replacement only, aged 60 years and older. Of the 1289 patients studied, 927 (71.9%) were male, and 1042 (80.8%) were 65 years of age or older; 376 (29.2%) were diabetic, 65 (5.0%) had a LVEF \< 30%, and 388 (30.1%) had a prior MI. None of the demographic or medical history differences between the randomized groups achieved statistical significance (p\<0.05). 

> *Study Methods*

####### An independent Clinical Events Committee, blinded to the treatment arm, adjudicated all major clinical events. Clinical follow-up for all treated patients extended to 30-days post-procedure or discharge, whichever occurred first. All randomized patients were included in the intent-to-treat analysis.

> *Study Results*

####### 173 (13.4%) of the randomized 1289 patients underwent a valve repair or replacement procedure, while 1116 (86.6%) received a CABG procedure. Partial occlusion clamps were used in 521 (40.4%) of the cases, the mean CPB and cross clamp times for Treatment (Control) were 91.6 (88.8) and 64.3 (63.3) minutes, respectively. For the Treatment patients, the EMBOL•X Aortic Filter was in-place for a mean of 20.9 minutes (range of 0-59 minutes). None of the surgical procedure differences between the randomized groups achieved statistical significance (p\<0.05).

> **[Table 2:]{.underline} Major Adverse Events (to 30 days)**
>
> Number (%)

+--------------------+-------+------+-----+-----------+--------------+
| ######### Event    | **T   | **C  | **  | **RR**    | **           |
|                    | reatm | ontr | P-V |           | Difference** |
|                    | ent** | ol** | alu | **(95%    |              |
|                    |       |      | e** | CI)**     | **(95% CI)** |
|                    | *     | **(  |     |           |              |
|                    | *(N=6 | N=64 |     |           |              |
|                    | 45)** | 4)** |     |           |              |
+--------------------+-------+------+-----+-----------+--------------+
| Death              | 10    | 11   | 0   | 0.91      | -0.002       |
|                    | (1.6) | (    | .82 | (0.39 --  | (-0.015 --   |
|                    |       | 1.7) |     | 2.12)     | 0.012)       |
+--------------------+-------+------+-----+-----------+--------------+
| Neurologic deficit | 18    | 18   | 1   | 1.00      | 0.000        |
| (Stroke/TIA)       | (2.8) | (    | .00 | (0.52 --  | (-0.018 --   |
|                    |       | 2.8) |     | 1.90)     | 0.018)       |
+--------------------+-------+------+-----+-----------+--------------+
| Renal              | 40    | 52   | 0   | 0.77      | -0.019       |
| insufficiency (RI) | (6.2) | (    | .19 | (0.52 --  | (-0.047 --   |
|                    |       | 8.1) |     | 1.14)     | 0.009)       |
+--------------------+-------+------+-----+-----------+--------------+
| > RI (w/o          | 33    | 43   | 0   | 0.77      | -0.016       |
| > dialysis)        | (5.1) | (    | .23 | (0.49 --  | (-0.041 --   |
|                    |       | 6.7) |     | 1.19)     | 0.010)       |
+--------------------+-------+------+-----+-----------+--------------+
| > RI (dialysis)    | 7     | 9    | 0   | 0.78      | -0.003       |
|                    | (1.1) | (    | .61 | (0.29 --  | (-0.015 --   |
|                    |       | 1.4) |     | 2.07)     | 0.009)       |
+--------------------+-------+------+-----+-----------+--------------+
| Myocardial         | 67    | 64   | 0   | 1.05      | 0.004        |
| infarction (MI)    | (     | (    | .79 | (0.76 --  | (-0.028 --   |
|                    | 10.4) | 9.9) |     | 1.45)     | 0.037)       |
+--------------------+-------+------+-----+-----------+--------------+
| > Q Wave MI        | 21    | 18   | 0   | 1.16      | 0.005        |
|                    | (3.3) | (    | .63 | (0.63 --  | (-0.014 --   |
|                    |       | 2.8) |     | 2.17)     | 0.023)       |
+--------------------+-------+------+-----+-----------+--------------+
| > CK-MB Elevation  | 46    | 46   | 0   | 1.00      | 0.000        |
|                    | (7.1) | (    | .99 | (0.67 --  | (-0.028 --   |
|                    |       | 7.1) |     | 1.48)     | 0.028)       |
+--------------------+-------+------+-----+-----------+--------------+
| Gastrointestinal   | 5     | 5    | 1   | 1.00      | 0.000        |
| complications (GI) | (0.8) | (    | .00 | (0.29 --  | (-0.010 --   |
|                    |       | 0.8) |     | 3.43)     | 0.010)       |
+--------------------+-------+------+-----+-----------+--------------+
| Limb ischemia      | 3     | 3    | 1   | 1.00      | 0.000        |
|                    | (0.5) | (    | .00 | (0.20 --  | (-0.007 --   |
|                    |       | 0.5) |     | 4.93)     | 0.007)       |
+--------------------+-------+------+-----+-----------+--------------+
| Any event          | 110   | 122  | 0   | 0.90      | -0.019       |
|                    | (     | (1   | .38 | (0.71 --  | (-0.061 --   |
|                    | 17.1) | 8.9) |     | 1.14)     | 0.023)       |
+--------------------+-------+------+-----+-----------+--------------+

*Death:* Death for any cause

*Stroke:* Central neurologic deficit persisting for \> 24 hours

*Transient neurologic deficit (TIA):* An ischemic event of the central
nervous system that causes a neurologic deficit persisting for \< 24
hours

*Renal insufficiency:* Increase of serum creatinine to \> 2.0 mg/dl
[or]{.underline} a 50% or greater increase over abnormal baseline prior
to procedure

*Renal insufficiency (dialysis):* The new requirement for dialysis

*Q-Wave MI*: New pathological Q-Waves in 2 or more contiguous leads

*Non Q-Wave MI:* CPK \> 5x normal and CK-MB \> 5x above the upper limit
of normal for the institution, in the absence of new Q-Waves

*Gastro-Intestinal Complications*: include GI bleeding requiring
transfusion; Pancreatitis with abnormal amylase/lipase requiring NG
suction therapy; Cholecystitis requiring cholecystectomy or drainage;
Mesenteric ischemia requiring exploration

*Limb-threatening Peripheral Embolism:* Acute onset of diminished pulse,
altered pallor (discoloration, either hypo- or hyper-), and pain as
evidence of limb-threatening peripheral ischemia

> 18 of 22 enrolling centers performed peri-procedural ultrasound
> imaging (TEE or EPI), resulting in an subset analysis of 70.6% of the
> randomized patients.
>
> **[Table 3:]{.underline} Echocardiographically Evident Endothelial
> Disruptions Observed through Imaging**

+-----------------+-------------+-----------+--------------------------+
| **Treatment**   | **Control** | **        | **Difference**           |
|                 |             | P-Value** |                          |
| **n/N (%)**     | **n/N (%)** |           | **(95% CI)**             |
+-----------------+-------------+-----------+--------------------------+
| 42/456 (9.2)    | 9/454 (2.0) | \< 0.001  | 0.072 (0.048 -- 0.097)   |
+-----------------+-------------+-----------+--------------------------+

As shown below, the presence of an echocardiographically evident
endothelial disruption did not put the patient at a statistically
greater risk for a composite endpoint event.

> **[Table 4:]{.underline} Composite Endpoint Events Stratified by
> Echocardiographically Evident Endothelial Disruptions Observed through
> Imaging**

+-------+-----------------+-------------------+------+----------------+
| ###   | **Events in     | **Events in       | **P  | **Difference** |
| ##### | Patients With   | Patients          | -Val |                |
| # Arm | Endothelial     | Without**         | ue** | **(95% CI)**   |
|       | Disruption**    |                   |      |                |
|       |                 | **Endothelial     |      |                |
|       | **n/N (%)**     | Disruption**      |      |                |
|       |                 |                   |      |                |
|       |                 | **n/N (%)**       |      |                |
+-------+-----------------+-------------------+------+----------------+
| Trea  | 2/42 (4.8)      | 74/414 (17.9)     | 0.03 | -0.131 (-0.205 |
| tment |                 |                   |      | -- -0.057)     |
+-------+-----------------+-------------------+------+----------------+
| Co    | 1/9 (11.1)      | 81/445 (18.2)     | 1.0  | -0.071 (-0.279 |
| ntrol |                 |                   |      | -- 0.138       |
+-------+-----------------+-------------------+------+----------------+

> **[Table 5:]{.underline} Composite Endpoint Events Within Various
> Subgroups**

+---------------+----------+---------+---+-----------+---------------+
| ### Subgroup  | *        | **Co    | * | **RR**    | *             |
|               | *EMBOL•X | ntrol** | * |           | *Difference** |
|               | Filter** |         | P | **(95%    |               |
|               |          | **n/N   | * | CI)**     | **(95% CI)**  |
|               | **n/N    | (%)**   | * |           |               |
|               | (%)**    |         |   |           |               |
+---------------+----------+---------+---+-----------+---------------+
| Type of       |          |         |   |           |               |
| Surgery       |          |         |   |           |               |
+---------------+----------+---------+---+-----------+---------------+
| CABG          | 95/556   | 104/560 | 0 | 0.92      | -0.015        |
|               | (17.1)   | (18.6)  | . | (0.71 --  | (-0.060 --    |
|               |          |         | 5 | 1.18)     | 0.030)        |
|               |          |         | 2 |           |               |
+---------------+----------+---------+---+-----------+---------------+
| Valve         | 15/89    | 18/84   | 0 | 0.79      | -0.046        |
|               | (16.9)   | (21.4)  | . | (0.42 --  | (-0.163 --    |
|               |          |         | 4 | 1.46)     | 0.071)        |
|               |          |         | 4 |           |               |
+---------------+----------+---------+---+-----------+---------------+
| Sex           |          |         |   |           |               |
+---------------+----------+---------+---+-----------+---------------+
| Male          | 79/470   | 90/457  | 0 | 0.85      | -0.029        |
|               | (16.8)   | (19.7)  | . | (0.65 -   | (-0.079 --    |
|               |          |         | 2 | 1.12)     | 0.021)        |
|               |          |         | 6 |           |               |
+---------------+----------+---------+---+-----------+---------------+
| Female        | 31/177   | 32/185  | 0 | 1.01      | 0.002 (-0.076 |
|               | (17.5)   | (17.3)  | . | (0.65 -   | -- 0.080)     |
|               |          |         | 9 | 1.59)     |               |
|               |          |         | 6 |           |               |
+---------------+----------+---------+---+-----------+---------------+
| Age Group     |          |         |   |           |               |
+---------------+----------+---------+---+-----------+---------------+
| \< 65         | 18/130   | 19/117  | 0 | 0.85      | -0.024        |
|               | (13.9)   | (16.2)  | . | (0.47 --  | (-0.113 --    |
|               |          |         | 6 | 1.54)     | 0.065)        |
|               |          |         | 0 |           |               |
+---------------+----------+---------+---+-----------+---------------+
| 65 -- 69      | 29/160   | 32/181  | 0 | 1.03      | 0.004 (-0.077 |
|               | (18.1)   | (17.7)  | . | (0.65 --  | -- 0.086)     |
|               |          |         | 9 | 1.62)     |               |
|               |          |         | 1 |           |               |
+---------------+----------+---------+---+-----------+---------------+
| 70 -- 74      | 23/158   | 26/152  | 0 | 0.85      | -0.025        |
|               | (14.6)   | (17.1)  | . | (0.51 --  | (-0.107 --    |
|               |          |         | 5 | 1.42)     | 0.056)        |
|               |          |         | 4 |           |               |
+---------------+----------+---------+---+-----------+---------------+
| 75 -- 79      | 26/129   | 24/121  | 0 | 1.02      | 0.003 (-0.096 |
|               | (20.2)   | (19.8)  | . | (0.62 --  | -- 0.102)     |
|               |          |         | 9 | 1.67)     |               |
|               |          |         | 5 |           |               |
+---------------+----------+---------+---+-----------+---------------+
| ≥ 80          | 14/68    | 21/73   | 0 | 0.72      | -0.082        |
|               | (20.6)   | (28.8)  | . | (0.40 --  | (-0.224 --    |
|               |          |         | 2 | 1.29)     | 0.061)        |
|               |          |         | 6 |           |               |
+---------------+----------+---------+---+-----------+---------------+
| ≥ 75          | 40/197   | 45/194  | 0 | 0.88      | -0.029        |
|               | (20.3)   | (23.2)  | . | (0.60 --  | (-0.111 --    |
|               |          |         | 4 | 1.28)     | 0.053)        |
|               |          |         | 9 |           |               |
+---------------+----------+---------+---+-----------+---------------+
| BMI           |          |         |   |           |               |
+---------------+----------+---------+---+-----------+---------------+
| \< 25 kg/m^2^ | 18/162   | 30/157  | 0 | 0.58      | -0.080        |
|               | (11.1)   | (19.1)  | . | (0.34 --  | (-0.158 --    |
|               |          |         | 0 | 1.00)     | -0.001)       |
|               |          |         | 5 |           |               |
+---------------+----------+---------+---+-----------+---------------+
| 25-29.9       | 55/294   | 51/288  | 0 | 1.06      | 0.010 (-0.053 |
| kg/m^2^       | (18.7)   | (17.7)  | . | (0.75 -   | -- 0.073)     |
|               |          |         | 7 | 1.49)     |               |
|               |          |         | 5 |           |               |
+---------------+----------+---------+---+-----------+---------------+
| ≥ 30 kg/m^2^  | 37/191   | 41/197  | 0 | 0.93      | -0.014        |
|               | (19.4)   | (20.8)  | . | (0.63 -   | (-0.094 --    |
|               |          |         | 7 | 1.38)     | 0.065)        |
|               |          |         | 2 |           |               |
+---------------+----------+---------+---+-----------+---------------+
| LVEF          |          |         |   |           |               |
+---------------+----------+---------+---+-----------+---------------+
| ≤ 25%         | 3/30     | 10/29   | 0 | 0.29      | -0.245        |
|               | (10.0)   | (34.5)  | . | (0.09 -   | (-0.456 --    |
|               |          |         | 0 | 0.95)     | -0.033)       |
|               |          |         | 2 |           |               |
+---------------+----------+---------+---+-----------+---------------+
| \> 25%        | 106/615  | 112/613 | 0 | 0.94      | -0.010        |
|               | (17.2)   | (18.3)  | . | (0.74 -   | (-0.053 --    |
|               |          |         | 6 | 1.20)     | 0.032)        |
|               |          |         | 4 |           |               |
+---------------+----------+---------+---+-----------+---------------+
| Plaque        |          |         |   |           |               |
+---------------+----------+---------+---+-----------+---------------+
| Present       | 12/82    | 18/93   | 0 | 0.76      | -0.047        |
|               | (14.6)   | (19.4)  | . | (0.39 --  | (-0.159 --    |
|               |          |         | 4 | 1.47)     | 0.065)        |
|               |          |         | 1 |           |               |
+---------------+----------+---------+---+-----------+---------------+
| Absent        | 59/350   | 57/342  | 0 | 1.01      | 0.002 (-0.054 |
|               | (16.9)   | (16.7)  | . | (0.73 --  | -- 0.058)     |
|               |          |         | 9 | 1.41)     |               |
|               |          |         | 5 |           |               |
+---------------+----------+---------+---+-----------+---------------+
| Not Evaluable | 39/213   | 47/209  | 0 | 0.81      | -0.042        |
|               | (18.3)   | (22.5)  | . | (0.56 --  | (-0.119 --    |
|               |          |         | 2 | 1.19)     | 0.035)        |
|               |          |         | 9 |           |               |
+---------------+----------+---------+---+-----------+---------------+
| Hypertension  |          |         |   |           |               |
+---------------+----------+---------+---+-----------+---------------+
| Yes           | 87/504   | 102/483 | 0 | 0.82      | -0.039        |
|               | (17.3)   | (21.1)  | . | (0.63 --  | (-0.088 --    |
|               |          |         | 1 | 1.06)     | 0.011)        |
|               |          |         | 2 |           |               |
+---------------+----------+---------+---+-----------+---------------+
| No            | 23/141   | 20/161  | 0 | 1.31      | 0.039 (-0.040 |
|               | (16.3)   | (12.4)  | . | (0.75 --  | -- 0.118)     |
|               |          |         | 3 | 2.29)     |               |
|               |          |         | 3 |           |               |
+---------------+----------+---------+---+-----------+---------------+
| Renal         |          |         |   |           |               |
| Insufficiency |          |         |   |           |               |
+---------------+----------+---------+---+-----------+---------------+
| Yes           | 6/17     | 10/16   | 0 | 0.56      | -0.272        |
|               | (35.3)   | (62.5)  | . | (0.27 --  | (-0.613 --    |
|               |          |         | 1 | 1.19)     | 0.069)        |
|               |          |         | 2 |           |               |
+---------------+----------+---------+---+-----------+---------------+
| No            | 104/628  | 112/628 | 0 | 0.93      | -0.013        |
|               | (16.6)   | (17.8)  | . | (0.73 --  | (-0.054 --    |
|               |          |         | 5 | 1.18)     | 0.029)        |
|               |          |         | 5 |           |               |
+---------------+----------+---------+---+-----------+---------------+
| Diabetes      |          |         |   |           |               |
+---------------+----------+---------+---+-----------+---------------+
| Yes           | 42/183   | 37/193  | 0 | 1.20      | 0.038 (-0.045 |
|               | (23.0)   | (19.2)  | . | (0.81 --  | -- 0.120)     |
|               |          |         | 3 | 1.77)     |               |
|               |          |         | 7 |           |               |
+---------------+----------+---------+---+-----------+---------------+
| No            | 68/462   | 85/451  | 0 | 0.78      | -0.041        |
|               | (14.7)   | (18.9)  | . | (0.58 --  | (-0.090 --    |
|               |          |         | 1 | 1.05)     | 0.007)        |
|               |          |         | 0 |           |               |
+---------------+----------+---------+---+-----------+---------------+
| Prior Stroke  |          |         |   |           |               |
+---------------+----------+---------+---+-----------+---------------+
| Yes           | 2/21     | 7/33    | 0 | 0.45      | -0.117        |
|               | (9.5)    | (21.2)  | . | (0.10 --  | (-0.321 --    |
|               |          |         | 4 | 1.96)     | 0.087)        |
|               |          |         | 6 |           |               |
+---------------+----------+---------+---+-----------+---------------+
| No            | 108/624  | 115/611 | 0 | 0.92      | -0.015        |
|               | (17.3)   | (18.8)  | . | (0.73 --  | (-0.058 --    |
|               |          |         | 4 | 1.17)     | 0.028)        |
|               |          |         | 9 |           |               |
+---------------+----------+---------+---+-----------+---------------+
| Ce            |          |         |   |           |               |
| rebrovascular |          |         |   |           |               |
| Disease       |          |         |   |           |               |
+---------------+----------+---------+---+-----------+---------------+
| Yes           | 5/30     | 14/35   | 0 | 0.42      | -0.233        |
|               | (16.7)   | (40.0)  | . | (0.17 --  | (-0.455 --    |
|               |          |         | 0 | 1.02)     | -0.012)       |
|               |          |         | 4 |           |               |
+---------------+----------+---------+---+-----------+---------------+
| No            | 105/617  | 108/607 | 0 | 0.96      | -0.008        |
|               | (17.0)   | (17.8)  | . | (0.75 --  | (-0.050 --    |
|               |          |         | 7 | 1.22)     | 0.035)        |
|               |          |         | 2 |           |               |
+---------------+----------+---------+---+-----------+---------------+
| Prior Stroke  |          |         |   |           |               |
| or            |          |         |   |           |               |
| Ce            |          |         |   |           |               |
| rebrovascular |          |         |   |           |               |
| Disease       |          |         |   |           |               |
+---------------+----------+---------+---+-----------+---------------+
| Yes           | 6/43     | 17/56   | 0 | 0.46      | -0.164        |
|               | (14.0)   | (30.4)  | . | (0.20 --  | (-0.332 --    |
|               |          |         | 0 | 1.07)     | 0.004)        |
|               |          |         | 6 |           |               |
+---------------+----------+---------+---+-----------+---------------+
| No            | 104/602  | 105/588 | 0 | 0.97      | -0.006        |
|               | (17.3)   | (17.9)  | . | (0.76 --  | (-0.049 --    |
|               |          |         | 7 | 1.24)     | 0.037)        |
|               |          |         | 9 |           |               |
+---------------+----------+---------+---+-----------+---------------+
| Peripheral    |          |         |   |           |               |
| Vascular      |          |         |   |           |               |
| Disease       |          |         |   |           |               |
+---------------+----------+---------+---+-----------+---------------+
| Yes           | 21/88    | 26/87   | 0 | 0.80      | -0.060        |
|               | (23.9)   | (29.9)  | . | (0.49 --  | (-0.192 --    |
|               |          |         | 3 | 1.31)     | 0.071)        |
|               |          |         | 7 |           |               |
+---------------+----------+---------+---+-----------+---------------+
| No            | 89/557   | 96/557  | 0 | 0.93      | -0.013        |
|               | (16.0)   | (17.2)  | . | (0.71 --  | (-0.056 --    |
|               |          |         | 5 | 1.21)     | 0.031)        |
|               |          |         | 7 |           |               |
+---------------+----------+---------+---+-----------+---------------+
| COPD          |          |         |   |           |               |
+---------------+----------+---------+---+-----------+---------------+
| Yes           | 19/82    | 17/87   | 0 | 1.19      | 0.036 (-0.087 |
|               | (23.2)   | (19.5)  | . | (0.66 --  | -- 0.160)     |
|               |          |         | 5 | 2.12)     |               |
|               |          |         | 6 |           |               |
+---------------+----------+---------+---+-----------+---------------+
| No            | 91/565   | 105/555 | 0 | 0.85      | -0.028        |
|               | (16.1)   | (18.9)  | . | (0.66 --  | (-0.073 --    |
|               |          |         | 2 | 1.10)     | 0.016)        |
|               |          |         | 2 |           |               |
+---------------+----------+---------+---+-----------+---------------+
| Vent.         |          |         |   |           |               |
| Arrhythmia    |          |         |   |           |               |
+---------------+----------+---------+---+-----------+---------------+
| Yes           | 8/41     | 11/29   | 0 | 0.51      | -0.184        |
|               | (19.5)   | (37.9)  | . | (0.24 --  | (-0.396 --    |
|               |          |         | 0 | 1.12)     | 0.027)        |
|               |          |         | 9 |           |               |
+---------------+----------+---------+---+-----------+---------------+
| No            | 102/606  | 111/613 | 0 | 0.93      | -0.013        |
|               | (16.8)   | (18.1)  | . | (0.73 --  | (-0.055 --    |
|               |          |         | 5 | 1.19)     | 0.030)        |
|               |          |         | 6 |           |               |
+---------------+----------+---------+---+-----------+---------------+

> **[Table 6:]{.underline} Summary of Particulate Capture
> Effectiveness**

  --------------------------------------------------- -------------------
  **Attribute**                                       **Result**

  Number EMBOL•X Filters Deployed                     618

  Number (%) Filters Which Captured ≥ 1 Particle      598 (96.8%)

  Lower 95% Confidence Bound on Percent of Filters    95.3%
  Which Captured ≥ 1 Particle                         
  --------------------------------------------------- -------------------

> **[Table 7:]{.underline} Captured Particulate Histology ^1^**
>
> Percent (*n*)

+----------------------------+--------------+------------+-----------+
| ##                         | ########     | **Ra       | **Ran     |
| # Histological description | # Randomized | ndomized** | domized** |
|                            |              |            |           |
| (N= 623 Filter Treatment   | **CABG and   | **CABG**   | **Valve** |
| Cases)^1,2^                | Valve**      |            |           |
|                            |              | #          | #         |
|                            | ### (n=623)  | ## (n=538) | ## (n=85) |
+----------------------------+--------------+------------+-----------+
| Total Dissolved/No emboli  | 24.4 (152)   | 24.2 (130) | 25.9 (22) |
+----------------------------+--------------+------------+-----------+
| Total Filters for          | 75.6 (471)   | 75.8 (408) | 74.1 (63) |
| Histological Analysis      |              |            |           |
+----------------------------+--------------+------------+-----------+
| Fibrous Atheroma           | 86.6 (408)   | 87.0 (355) | 84.1 (53) |
+----------------------------+--------------+------------+-----------+
| Fibrocalcific Atheroma     | 3.4 (16)     | 1.0 (4)    | 19.0 (12) |
+----------------------------+--------------+------------+-----------+
| Grumous atheroma /         | 1.3 (6)      | 1.5 (6)    | 0 (0)     |
| cholesterol                |              |            |           |
+----------------------------+--------------+------------+-----------+
| Medial tissue              | 0.6 (3)      | 0.7 (3)    | 0 (0)     |
+----------------------------+--------------+------------+-----------+
| Fibrofatty/Adventitial     | 1.7 (8)      | 1.0 (4)    | 6.3 (4)   |
| tissue                     |              |            |           |
+----------------------------+--------------+------------+-----------+
| Platelets/Fibrin           | 37.8 (178)   | 37.0 (151) | 42.9 (27) |
+----------------------------+--------------+------------+-----------+
| True RBC thrombus/Clot     | 2.1 (10)     | 2.0 (8)    | 3.2 (2)   |
+----------------------------+--------------+------------+-----------+
| Dissolved (during          | 21.0 (131)   | 20.6 (111) | 23.5 (20) |
| processing) ^2^            |              |            |           |
+----------------------------+--------------+------------+-----------+
| No particulate emboli      | 3.4 (21)     | 3.5 (19)   | 2.4 (2)   |
| observed                   |              |            |           |
+----------------------------+--------------+------------+-----------+
| Particulate Capture Rate   | 96.6 (602)   | 96\. 5     | 97.6 (83) |
| per Filter                 |              | (519)      |           |
+----------------------------+--------------+------------+-----------+

> 1 Totals may not equal 100% due to multiple particulates within the
> same Filter.
>
> 2 Filters with dissolved and 0 samples not included in percentage
> calculations of histologic composition.
>
> *Conclusions*

The primary safety endpoint was met, with the EMBOL•X Aortic Filter arm
composite event rate statistically equivalent to that of standard
treatment (17.1% vs. 18.9%, p\<0.001). In addition, differences in the
stratified events between the randomized groups did not achieve
statistical significance (p\<0.05). The primary effectiveness endpoint
was also met, with particulate capture demonstrated in 96.8% of all
filters analyzed (p\<0.001). It was therefore concluded that the EMBOL•X
Aortic Filter safety profile was equivalent to that of the current
standard treatment of no filtration, and the Filter was effective in
capturing particulates.

# 8. METHOD OF USE

#### I. Materials Required

-   Container of sterile normal saline solution for wetting the filter
    prior to use.

-   EMBOL•X Aortic Cannula for vascular access to the aorta.

-   EMBOL•X Aortic Sizers (optional).

#### II. Inspection Prior to Use

Prior to opening and use, visually examine:

-   The package integrity. If the package sterile integrity appears to
    have been jeopardized, do not use.

-   Remove the EMBOL•X Aortic Filter from the package and inspect to
    ensure that it has not been damaged or has components missing. If
    the device appears damaged or has components missing, do not use.

-   The Filter's vent knob, a built in self-venting plug for exposures
    to any fluids. This would prevent the plug from venting air
    properly. The plug is only able to vent air once and will stop
    venting once fluids contact it. If the vent plug appears to have
    contacted fluids prior to Filter insertion, do not use.

#### III. Preparation for Use

-   Verify that there are no aneurysmal changes or trauma present in the
    ascending aorta.

-   Visually estimate the diameter of the ascending aorta.

-   If an EMBOL•X Aortic Sizer is used, choose one which most closely
    represents the size of the aorta. Using the Sizer, measure the outer
    diameter (OD) of the aorta.

-   Once the outer diameter has been established, estimate the wall
    thickness of the aorta. The inner diameter (ID) of the aorta is
    estimated by subtracting twice the wall thickness from the outer
    diameter of the aorta \[ID = OD -- (2x wall thickness)\]. Select the
    appropriate sized EMBOL•X Aortic Filter based on the aortic inner
    diameter (refer to Table 8, below).

-   The Filter vent knob will vent once and will stop venting once fluid
    contacts it. For this reason, it is important to keep the Filter
    cartridge upright during preparation after submersion to ensure that
    saline inside the cartridge does not wet the vent knob.

-   Maintaining the Filter cartridge in an upright position, thoroughly
    moisten the EMBOL•X Aortic Filter by submerging the distal Filter
    end in a container of sterile saline and slowly swirling it around
    the container. This is intended to remove all air from the Filter
    material. Do not submerge the Filter plunger knob as this will
    prevent it from venting properly once the Filter is inserted.

-   Retract the EMBOL•X Aortic Filter fully into the cartridge while
    gently pinching the edges of the Filter between your thumb and
    forefinger and guiding the edges of the Filter upwards.

+-----------------------------------------------------------------------+
| **WARNING**: Do not use a single EMBOL•X Aortic Filter more than      |
| once. This may result in:                                             |
|                                                                       |
| -   Air embolism, since the porous plug on the Filter plunger will    |
|     vent only once;                                                   |
|                                                                       |
| -   Increased risk of thrombus formation, which may make the Filter   |
|     difficult to insert and remove; or                                |
|                                                                       |
| -   Distortion of the Filter frame.                                   |
+-----------------------------------------------------------------------+

  -----------------------------------------------------------------------
  **WARNING**: Failure to remove all air from the EMBOL•X Aortic Filter
  may result in air embolism.

  -----------------------------------------------------------------------

**Table 8: EMBOL•X Aortic Filter Sizes and Aortic Internal Diameters.**

+----------------+--------------------------+--------------------------+
| #########      | **Minimum Aortic**       | **Maximum Aortic**       |
|  Aortic Filter |                          |                          |
|                | **Inner Diameter (cm)**  | **Inner Diameter (cm)**  |
| #              |                          |                          |
| ######## Sizes |                          |                          |
+----------------+--------------------------+--------------------------+
| X-Small        | 2.2 cm                   | 2.6 cm                   |
+----------------+--------------------------+--------------------------+
| Small          | 2.6 cm                   | 2.9 cm                   |
+----------------+--------------------------+--------------------------+
| Medium         | 2.9 cm                   | 3.2 cm                   |
+----------------+--------------------------+--------------------------+
| Large          | 3.2 cm                   | 3.5 cm                   |
+----------------+--------------------------+--------------------------+
| X-Large        | 3.5 cm                   | 4.0 cm                   |
+----------------+--------------------------+--------------------------+

#### IV. Insertion and Deployment of the EMBOLX Aortic Filter 

-   After CPB has been initiated and JUST PRIOR to removing the aortic
    cross clamp, prepare to deploy the EMBOL•X Aortic Filter.

-   While holding the cannula to prevent excessive force on the aorta,
    unlock the obturator and remove it from the EMBOL•X Aortic Cannula
    Introducer port. The one-way valve will prevent excessive
    backbleeding.

-   While still holding the cannula, slowly insert the EMBOL•X Aortic
    Filter (retracted into cartridge) into the Introducer port until an
    audible "click" is heard. The EMBOL•X Aortic Filter is now locked in
    place.

-   Confirm de-airing of the Filter and cartridge by looking for blood
    in the knob of the plunger. If blood is not visible in the knob, DO
    NOT DEPLOY the filter. Remove the Filter and insert a new one.

-   Deploy the EMBOL•X Aortic Filter by slowly pushing the plunger all
    the way down.

-   If resistance is met during deployment and the Filter will not
    deploy, check the marker band on the plunger shaft to view the
    position of the indicator line relative to the cartridge handle. If
    the line is still visible (e.g., not deployed past the handle), the
    Filter has not yet exited the Introducer port. If the line is
    already deployed past the handle, the Filter may be already deployed
    into the aorta. Ensure that the EMBOL•X Aortic Cannula is positioned
    so that the Introducer port is perpendicular to the aorta prior to
    attempting to re-deploy the Filter. If using pledgets, place them on
    either side of the Cannula instead of in front of the Cannula.
    Ensure that the Cannula Introducer port is not exposed to the
    outside of the aorta due to the pledget lifting the Cannula out of
    the aorta. See EMBOL•X Aortic Cannula IFU for positioning
    requirements and techniques.

-   Remove the aortic cross-clamp. A partial occlusion clamp may be
    applied and removed while the filter in place. Remove the partial
    occlusion clamp prior to EMBOL•X Aortic Filter removal.

-   The EMBOL•X Aortic Filter may be left in place for up to 60 minutes
    to collect any emboli that may result from the clamping procedure or
    manipulation of the ascending aorta and heart during CPB surgery.

  -----------------------------------------------------------------------
  **WARNING**: Although the EMBOL•X Aortic Cannula may be used separately
  in place of a standard arterial return cannula, the EMBOL•X Aortic
  Filter must be used in conjunction with the EMBOL•X Aortic Cannula.

  -----------------------------------------------------------------------

  -----------------------------------------------------------------------
  **WARNING**: Hold the base of the Introducer port of EMBOL•X Aortic
  Cannula while inserting the EMBOL•X Aortic Filter. Failure to do so may
  cause injury to the aorta.

  -----------------------------------------------------------------------

  -----------------------------------------------------------------------
  **WARNING**: Do not deploy the EMBOL•X Aortic Filter if excessive
  resistance is felt. Attempting to deploy the EMBOL•X Aortic Filter when
  resistance is felt may indicate improper positioning of the cannula.
  Forcing deployment may cause injury to the aorta.

  -----------------------------------------------------------------------

  -----------------------------------------------------------------------
  **WARNING**: Do not manipulate or reposition the EMBOL•X Aortic Cannula
  or EMBOL•X Aortic Filter shaft with the Filter deployed. If the cannula
  must be repositioned, first retract the Filter. Failure to do so may
  cause injury to the aorta.

  -----------------------------------------------------------------------

  -----------------------------------------------------------------------
  **WARNING**: Do not use a single EMBOL•X Aortic Filter intra-aortically
  for more than **60** (sixty) minutes.

  -----------------------------------------------------------------------

  -----------------------------------------------------------------------
  **WARNING**: The EMBOL•X Aortic Filter must be retracted and removed
  from the EMBOL•X Aortic Cannula Introducer port prior to routine
  administration of protamine for heparin reversal, since the Filter is
  heparin-coated. Failure to do so may result in thrombus formation on
  the Filter.

  -----------------------------------------------------------------------

  -----------------------------------------------------------------------
  **WARNING**: Ensure that the cross-clamp is positioned at least 2.0 cm
  away from the EMBOL•X Aortic Cannula. Failure to do so may result in
  difficulty with insertion and/or removal of the Filter.

  -----------------------------------------------------------------------

> **V. EMBOL•X Aortic Filter Removal**

-   Hold the cannula to stabilize the device and fully retract the
    EMBOL•X Aortic Filter into the cartridge by retracting the plunger
    until it stops.

-   Unlock and remove the EMBOL•X Aortic Filter by pinching the locking
    connector tabs together and slowly sliding the Filter out of the
    Introducer port.

  -----------------------------------------------------------------------
  **WARNING**: If resistance is met while retracting the EMBOL•X Aortic
  Filter into the cartridge, leave the Filter in place until the EMBOL•X
  Aortic Cannula can be removed with the Filter deployed, using standard
  decannulation techniques.

  -----------------------------------------------------------------------

9\. PHYSICIAN TRAINING

As a means to augment proper technique, EMBOL•X will, upon request,
provide the following training elements as needed to new centers
intending to utilize the EMBOL•X Aortic Filter:

-   In-Service: EMBOL•X representative will review the method of use and
    present procedural and case review materials prior to first clinical
    use;

-   Case support: EMBOL•X representative will support the first case;

-   Documentation: EMBOL•X representative will provide a document
    reflecting the completion of in-service and/or case support to the
    center.

# 10. HOW SUPPLIED

> **STERILE:** The device is provided STERILE and NON-PYROGENIC when in
> unopened, undamaged packaging. The device is sterilized by Gamma
> Radiation. For single use only. DO NOT resterilize. DO NOT REUSE.

# 

# CONTENTS: The EMBOL•X Aortic Filter is individually packaged.

# 

# STORAGE AND HANDLING: Store sterile packaged device in a cool, dry, dark place until ready for use. Do not expose to organic solvents, ionizing radiation, ultraviolet light, or alcohol-based fluids. 

# 11. ADDITIONAL INFORMATION

> For customer service or product information, please contact EMBOL•X,
> Inc. at the following address:
>
> **EMBOL•X, Inc.**
>
> 645 Clyde Avenue
>
> Mountain View, CA 94043-2208 USA
>
> Telephone: (650) 390 0280
>
> Fax: (650) 390 0282
>
> **DISCLAIMER OF WARRANTY**
>
> EMBOL•X MAKES NO EXPRESS OR IMPLIED WARRANTY WITH RESPECT TO THE
> PRODUCT(S) SOLD HEREUNDER, INCLUDING ANY IMPLIED WARRANTY OF
> MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, WHICH WARRANTIES
> ARE EXPRESSELY DISCLAIMED. TO THE EXTENT THAT ANY PRODUCT DESCRIPTIONS
> AND/OR SPECIFICATIONS ARE SET FORTH HEREIN, SAID SPECIFICATIONS AND/OR
> DESCRIPTIONS ARE INTENDED ONLY AS GENERAL LANGUAGE AND DO NOT
> CONSTITUTE AN EXPRESS WARRANTY THAT THE PRODUCT SHALL CONFORM TO THE
> DESCRIPTION AND/OR SPECIFICATION OF THE PRODUCT.
>
> This product, and the use thereof, is covered by U.S. Patent No.
> 5,846,260, 5,989,281, 6,007,557, 6,051,015, and other patents pending.
>
> EMBOL-X® name and logos are trademarks of EMBOL-X®, Inc.
>
> Printed in the USA.
>
>  2002, EMBOL-X®, Inc. All rights reserved. Printed in the USA

######### Graphical Symbols for Medical Device Labeling

+-----------------------------------------------------------------------+
| \[symbol\]                                                            |
|                                                                       |
| Sterile                                                               |
|                                                                       |
| \[symbol\]                                                            |
|                                                                       |
| Lot Number                                                            |
|                                                                       |
| \[symbol\]                                                            |
|                                                                       |
| Single Use                                                            |
|                                                                       |
| \[symbol\]                                                            |
|                                                                       |
| See Instructions for Use                                              |
|                                                                       |
| \[symbol\]                                                            |
|                                                                       |
| Use by                                                                |
|                                                                       |
| \[symbol\]                                                            |
|                                                                       |
| Catalog Number                                                        |
+-----------------------------------------------------------------------+

P/N XXXX Rev X