**CorCap**^™^ **Cardiac Support Device**

**Instructions for Use**

**DESCRIPTION**

![](media/image1.wmf){width="2.1215277777777777in"
height="2.1215277777777777in"}

The CorCap™ Cardiac Support Device (CSD) is a proprietary polyester mesh
wrap implanted around the heart to provide support and reduce
ventricular wall stress.

**INTENDED USE**

The CorCap CSD provides beneficial changes in cardiac structure
associated with a reverse remodeling effect as defined by a reduction in
left ventricular (LV) size, a reduction in LVEF, and a change to a more
elliptical shape. The CorCap CSD also provides a decrease in the need
for additional major cardiac procedures associated with the progression
of heart failure and an overall improvement in quality of life.

**INDICATIONS**

The CorCap CSD is indicated for use in adult patients who have been
diagnosed with dilated cardiomyopathy and are symptomatic despite
treatment with optimal heart failure medical management. Patients
appropriate for this procedure have a dilated heart (LVEDD
[\>]{.underline} 60mm or LVEDDI [\>]{.underline} 30mm/m^2^) and an LVEF
≤ 35% (LVEF [\<]{.underline} 45% if planned mitral valve repair
replacement).

**CONTRAINDICATIONS**

Patients with any condition considered to be a contraindication for
cardiac surgery should not undergo surgery for implant of the CorCap
CSD.

**WARNINGS**

1.  Do not perform procedure in patients with an active infection.

2.  Do not perform procedure in patients with primary restrictive
    disease.

3.  Patients who are not good candidates for cardiac surgery (i.e.,
    patients diagnosed with end-stage NYHA functional class IV or
    patients dependent upon intravenous inotropes, intra aortic balloon
    pump, and/or left ventricular assist device) may not be suitable
    candidates for CorCap CSD therapy.

4.  Placement of device over pre-existing coronary artery bypass grafts
    has not been evaluated and may compromise graft patency.

5.  In patients with previous CorCap CSD implant, location of
    appropriate anastomotic sites for coronary artery bypass surgery may
    be extremely difficult.

6.  Patients undergoing cardiac surgery may be at a greater risk for
    development of fibrosis and adhesions. This could potentially
    increase the surgical time required for subsequent cardiac
    surgeries.

**PRECAUTIONS**

1.  Patients with hypertrophic obstructive cardiomyopathy or primary
    diastolic dysfunction may not benefit from the CorCap CSD implant.

2.  Procedure may not be possible in patients with profound cardiomegaly
    (\>14.6 cm external cardiac diameter), which exceeds the largest
    CorCap CSD size available.

3.  As with any cardiac surgery, use of an adhesion barrier may be
    considered, particularly in patients with an increased potential for
    requiring future operations.

4.  Procedure requires ability to obtain complete circumferential access
    to the heart, which may be compromised in patients with pre-existing
    pericardial or epicardial adhesions.

5.  Alteration to the device or implant procedure beyond these
    instructions may result in unknown device performance.

6.  Direct application of antibiotics to the CorCap CSD should be
    avoided.

7.  Patient risks or discomforts expected include standard risks of a
    patient undergoing cardiothoracic surgery.  These may include: 
    bleeding; development of cardiac pulmonary embolism, infarct, or
    peripheral embolism; hemodynamic compromise potentially leading to
    cardiogenic shock and/or neurological deficit; infection; pneumonia;
    pulmonary, renal, or hepatic compromise potentially leading to
    failure; death; other surgical trauma; reoperation; and/or allergic
    response to anesthesia, medications or device material.

8.  Use of an IABP is recommended in patients whre manipulation of the
    heart could cause hemodynamic instability.

9.  If hemodynamic instability cannot be managed by pharmacological
    means, CPB is recommended.

**IMPLANT PROCEDURE**

1.  **[Expose the Heart]{.underline}**

The CorCap CSD can be implanted using standard surgical approaches. 
After gaining access, open the pericardium to expose the heart. It may
be helpful to use the pericardium as a cradle to position the heart for
better access.

2.  **[Obtain Heart Size Baseline Measurements for Device
    Fitting]{.underline}**

    a.  Obtain baseline intra-operative Left ventricular end-diastolic
        dimension (LVEDD) measurements using TEE.  While use of TEE is
        strongly recommended, heart size may be determined by measuring
        the circumference of the heart at its largest diameter (during
        end-diastole).

    b.  Measure the circumference of the heart at its largest diameter
        during end diastole. This measurement is typically near the AV
        groove.

    c.  Measure the length of the heart from apex to base during end
        diastole.

    d.  The CorCap Cord Sizer may be used for the circumferential and
        apex-to-base measurements.

**Note:**

-   Intraoperative conditions, including use of blood products, fluids
    and medications, may influence the size of the heart and therefore
    should be taken into account when obtaining baseline measurements.

-   Ensure that sizing tool is placed at true apex to obtain accurate
    measurements.

3.  **[Select the Correct CorCap CSD Size]{.underline}**

Compare the circumference and length measurements obtained in Step 2 to
the CorCap Size Selection Guide (Table 1) and select the device size
indicated.

**Table 1. CorCap CSD Sizing Chart**

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height="4.209722222222222in"}

**CAUTION:** Selection of a device that is smaller than indicated in the
sizing chart may lead to inappropriately reduction in cardiac size, or
necessitate intra-operative removal and replacement with an appropriate
sized device.

4.  **[Concomitant Cardiopulmonary Bypass or Cardiac
    Surgery]{.underline}**

If cardiopulmonary bypass will be used or concomitant MVR surgery
performed, review the "Special Conditions" section for related
modifications to the implant procedure.

5.  **[Open CorCap CSD Package]{.underline}**

Check integrity of CorCap CSD package. Do not use if damage to package
or seals is noted. Open the outer package and deliver the sterile inner
package to the sterile field.  Open the inner package and place CorCap
CSD in sterile saline until ready for implant.

6.  **[Inspect and Prepare the CorCap CSD]{.underline}**

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a.  Inspect CorCap CSD for any irregularities. Do not use if device is
    torn, frayed or missing threads.

b.  Remove the device tag, located on the outside of the CorCap CSD.

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7.  **[Secure Hem of CorCap CSD to Heart]{.underline}**

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a.  Position the CorCap CSD around the ventricles with the smooth side
    of hem and seam against the heart.

b.  Align device such that hem is positioned near level of the AV groove
    and seam is positioned on the anterior surface of the heart. Device
    length may extend beyond apex; this will be adjusted when new
    anterior seam is created (Steps 9-10). Do not shorten device by
    trimming hem.

c.  Starting at the most posterior location, secure the hem to the
    circumference of the heart near the AV groove using interrupted
    attachments every 2-4 cm. 

d.  Work from side to side placing attachments around the circumference,
    moving towards the mid-anterior of the heart. The fabric should not
    wrinkle or pucker between attachment points. 

e.  To facilitate seam fitting later in the procedure, fabric located
    within 5cm of the seam should *not* be attached to the heart at this
    time.

> **WARNING:** When securing device, ensure that attachments do not
> cause injury to coronary arteries.
>
> **WARNING:** Manipulation of the heart may precipitate arrhythmias
> and/or hemodynamic compromise, particularly during placement of
> posterior attachments.
>
> CAUTION: Use of an IABP is recommended in patients where manipulation
> of the heart could cause hemodynamic instability. If hemodynamic
> instability cannot be managed by pharmacological means, CPB is
> recommended.
>
> **Note:** Taper point needles and 4.0 or stronger non-bioabsorbable
> suture material are recommended for suturing; taper cut or other
> cutting needles may sever CorCap CSD fabric fibers.

8.  ![](media/image3.wmf){width="2.106299212598425in"
    height="2.8751968503937007in"}**[Approximate Anterior Seam of CorCap
    CSD]{.underline}**

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a.  Using CorCap™ fitting clamp, gather excess CorCap CSD fabric toward
    the anterior seam. (See **Figure 1**.)

b.  If device length extends beyond the apex, collect excess fabric into
    clamp.

c.  Check that the tension on the device is evenly distributed over the
    entire circumference of the CorCap CSD.

d.  The CorCap CSD should maintain complete contact with the ventricular
    walls throughout the cardiac cycle, with no gaps and no evidence of
    hemodynamic compromise.

e.  Measure LVEDD with TEE to anticipate final fit. Adjust the amount of
    gathered fabric within the clamp to ensure the appropriate degree of
    LVEDD reduction.

> **WARNING:** Reduction in LVEDD should not exceed 10% as compared to
> baseline.  Intraoperative conditions, including use of blood products,
> fluids and medications, may influence the size of the heart and
> therefore should be taken into account when approximating the CorCap
> CSD.

**CAUTION**: Do not decrease the apex to base dimension of the heart
while approximating the anterior seam.

**Note:** 

-   The clamp should not be allowed to rest on the heart, as this could
    lead to errors in dimensional measurements.

-   Use the CorCap fitting clamp for this procedure. Surgical clamps not
    specifically designed for this purpose could tear or snag the CorCap
    CSD fabric.

9.  **[Create New Anterior Seam]{.underline}**

With the CorCap fitting clamp in place, place a running mattress suture
under the jaws of the CorCap fitting clamp, starting at the apex and
continuing to the hem, to create a new anterior seam.

**Note:**

-   Taper point needles and 4.0 or stronger non-bioabsorbable suture
    material are recommended for suturing; taper cut or other cutting
    needles may sever CorCap CSD fabric fibers.

10. ![](media/image4.wmf){width="1.947244094488189in"
    height="2.5956692913385826in"}**[Trim Fabric]{.underline}**

Keeping the CorCap fitting clamp in place, trim fabric above the clamp
jaws. (See **Figure 2**.)

11. **[Complete Final Anterior Attachment]{.underline}**

Secure the device hem at the mid-anterior of the heart. 

near the AV groove using interrupted attachments every 2-4 cm. 

12. **[Reinforce New Anterior Seam]{.underline}**

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a.  ![](media/image5.png){width="1.958267716535433in"
    height="2.25in"}Remove the CorCap fitting clamp. There should be
    approximately 3-5mm of fabric remaining above the running suture.

b.  Reinforce the new anterior seam by placing a running interrupted
    suture from the apex to the hem. (See **Figure 3**.) Stitch should
    provide redundancy and leave no gaps in seam, while maintaining even
    tension on the device.

c.  Continuously evaluate final fit (see step #13) during placement of
    this new anterior seam. Adjust suture placement accordingly.

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13. **[Evaluate Final Fit of the CorCap CSD]{.underline}**

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a.  Evaluate fit using the Fabric Tension Test ("tent test").

    -   Using a blunt surgical instrument, gently lift fabric
        approximately 1-2 cm off the heart.

    -   Release the "tent" -- it should re-conform to the surface of the
        heart within 1-2 cardiac cycles.

    -   Repeat this test in several locations away from the hem and
        seams of the CorCap CSD.

b.  The CorCap CSD should cover both ventricles with no gaps between the
    device and the heart throughout the entire cardiac cycle.

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14. **[Measure Final Fit of the CorCap CSD]{.underline}**

    a.  Measure LVEDD with TEE at the same location used to obtain the
        baseline circumference measurement in Step 2. While use of TEE
        is strongly recommended, heart size may be determined by
        measuring the circumference of the heart at its largest diameter
        (during end-diastole).

> **WARNING:** Reduction should not exceed 10% as compared to baseline
> LVEDD.  Intraoperative conditions, including use of blood products,
> fluids and medications, may influence the size of the heart and
> therefore should be taken into account when fitting the CorCap CSD.

b.  If reduction in LVEDD of greater than 10% is noted, remove sutures
    from the anterior seam and adjust fit.  If suture removal damages
    the CorCap CSD or if there is not enough fabric to recreate a 3-5 mm
    seam, remove device and repeat procedure with a new device.

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15. **[Perform Final Inspection]{.underline}**

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a.  Remove any excess particulate matter that is found in-situ.

b.  Ensure that any fabric or seam damage is repaired

c.  Visually inspect the device and device hem to ensure that the device
    fits uniformly over all surfaces of the ventricles.

**SPECIAL CONSIDERATIONS**

1.  **[Cardiopulmonary Bypass]{.underline}**

If cardiopulmonary bypass is used, the following considerations are
advised:

a.  Baseline heart size measurements (Step 2) and size selection
    (Step 3) should be made before placing the patient on bypass. If
    this is not possible, heart should be filled to an approximation of
    baseline.

b.  Fitting of the device (Steps 8-12) should not be performed until
    patient is off bypass and has a full, stable beating heart.

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2.  **[Mitral Valve Repair/Replacement (MVR)]{.underline}**

> If concomitant mitral valve repair or replacement is indicated, the
> following considerations are advised:

c.  Baseline heart size measurements (Step 2) and size selection
    (Step 3) should be made before placing the patient on bypass. If
    this is not possible, heart should be filled to an approximation of
    baseline.

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a.  To minimize need for cardiac manipulation following placement of
    mitral valve prosthesis, position CorCap CSD and place posterior
    attachments prior to valve replacement or repair.

b.  Fitting of the device (Steps 8-12) should not be performed until
    patient is off bypass and has a full, stable beating heart post-MVR.

**DEVICE NOTES**

-   The CorCap CSD is provided sterile and is for single use only.

-   The CorCap CSD may not be resterilized.

-   The CorCap CSD is latex free.

-   The CorCap CSD is MRI compatible.

-   The CorCap CSD is nuclear scan-compatible.

-   The CorCap CSD does not complicate future cardiac catheterization.

**WARRANTY**

Acorn Cardiovascular, Inc., has taken reasonable care in the design and
manufacture of this product. Other than this representation, there are
NO EXPRESS OR IMPLIED WARRANTIES INCLUDING, WITHOUT LIMITATION, and
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

Acorn Cardiovascular, Inc., shall not be liable for any incidental or
consequential damages other than as expressly provided by specific law. 
No person has the authority to make any representation or warranty other
than as set forth in this paragraph.

**MANUFACTURER**

Acorn Cardiovascular, Inc.

601 Campus Drive

St. Paul, Minnesota  55112   USA

Tel:       651.286.4800

Fax:      651.286.4848

[www.acorncv.com](http://www.acorncv.com/)

**AUTHORIZED EU REPRESENTATIVE**

MedPass International Limited

Windsor House, Barnett Way, Barnwood

Gloucester GL4 3RT

United Kingdom

**Covered By United States And International Patents And Patent
Application.**

**CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER
OF A PHYSICIAN.**

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