Medtronic 49260 Instructions for Use

CARDIOBLATE

®

GEMINI

Surgical Ablation Device

49260, 49261

®

Instructions for Use

Caution: Federal law (USA) restricts

this device to sale by or on the order of a
physician.

Medtronic®, Cardioblate®, Gemini®, and Navigator® are registered trademarks of Medtronic, Inc.

Explanation of symbols on package labeling

Refer to the device labeling to see which symbols apply to this product

Nonpyrogenic

Sterilized Using Ethylene Oxide

Do Not Reuse

Do Not Resterilize

Do not use if package is damaged

Use By

Lot Number

Quantity

Consult Instructions for Use

For US Audiences Only

Upper Limit of Temperature

Humidity Limitation

Date of Manufacture

Catalog Number

Manufacturer

Type CF Applied Part

Contains di(2-ethylhexyl)phthalate (DEHP)

Authorized Representative in the European Community

1

Gemini®

5

6

3

7

2

1

4

8

9

4926149260

Surgical Ablation Device, Models 49260 and 49261

Figure 1

Rigid, slim-line jaws with guide attachments

1.

2. 6.3 cm (2.49 in) electrodes with embedded weeping polymer

3. RF Trigger

4. Flexible neck

5. Handle

6. Handle lock release

7. Molded hand piece

8. Saline fluid delivery tubing 304.8 cm (10 ft) in length with a female
luer for connection to standard IV tubing systems

9. Electrical cable 304.8 cm (10 ft) in length that terminates into a
multi-pin connector

2

CARDIOBLATE® GEMINI

®

Surgical Ablation Device

Models

49260, 49261

Description

The Medtronic Cardioblate® Gemini® Surgical Ablation Device is a
hand-held, single-use, bipolar, radiofrequency ablation device intended
to ablate cardiac tissue during cardiac surgery. It has a saline irrigation
system to deliver fluid at the contact point between the tissue and
electrode to cool the tissue during radiofrequency energy delivery. Two

jaw curvatures are provided: a standard curve (Model 49260) and

unique
extra curve (Model 49261). The device is intended for intermittent
operation.

Sterile, nonpyrogenic, disposable, single use only.

Indications for Use

The Cardioblate® Gemini® Surgical Ablation Device is intended to ablate
cardiac tissue during cardiac surgery using radiofrequency energy. The
system is indicated for use, under direct or endoscopic visualization, in
surgical procedures, including minimally invasive surgical procedures.

Contraindications

The Cardioblate® Gemini® Surgical Ablation Device should not be used
for:

■

patients that have active endocarditis at time of surgery

■

ablation in a pool of blood (eg, through a purse string suture
on a beating heart) (Effects of this type of ablation are
unknown.)

Adverse Effects

Possible adverse effects related to the ablation of cardiac tissue in
combination with open heart surgery are:

■

tissue perforation

■

extension of extracorporeal bypass

■

perioperative heart rhythm disturbances (atrial and/or
ventricular)

■

postoperative embolic complications

■

pericardial effusion or tamponade

■

injury to the great vessels

■

valve leaflet damage

■

conduction disturbances (SA/AV node)

■

acute ischemic myocardial event

■

thrombus formation

■

nerve damage

■

unintentional burns

■

pericarditis

■

pleural effusion

■

esophageal perforation

■

death

■

coronary sinus perforation

■

coronary artery spasm

■

atrial lead dislodgement

■

hypotension

■

pulmonary vein stenosis

■

cerebrovascular accident

■

transient ischemic attack

■

blood loss

Instructions for Use English 3

Warnings

Do not activate device if saline is not flowing freely. Cooling of the
outer tissue prevents the charring and tissue desiccation that may
occur when applying radiofrequency energy without irrigation.

device may be damaged before or during the procedure by improper

The
handling or other intervening acts. If damaged, the device may fail to
function properly, and may result in the following medical complications
including, but not limited to:

■

damage to the physiological conduction system

■

peripheral tissue ablation due to breach of insulation

covering
Device shall be removed from the patient before defibrillation.
No representation or warranty is made that failure or cessation of function

of the device will not result in an adverse event, or that medical
complications (including perforation of cardiac tissue) will not follow the
procedure, or that the use of the device will in all cases restore adequate
cardiac function.

Precautions

Caution: Federal law (USA) restricts this device to sale by or on the order

of a physician.
Proper surgical procedures and techniques are necessarily the

responsibility of the medical professional. Each surgeon must evaluate
the appropriateness of any procedure based on his or her own medical
training and experience, and the type of surgical procedure.

Patient and procedure selection is solely a medical responsibility and the
outcome is dependent on many variables including patient pathology,
surgical and perfusion procedures.

Use caution to visualize the target area to avoid trauma to tissues not
within the target area of ablation.

Purge air from system to ensure saline fluid flows from the electrodes
during use.

Separation of electrodes from tissue contact during activation will result
in a high impedance shutdown placing generator power condition to OFF.
Placing electrodes in direct contact during radiofrequency energy
activation results in a low impedance shutdown and places the generator
power condition to OFF. In both situations, three short audible alarm
beeps will be heard. Refer to the Cardioblate 68000 generator technical
manual for reset instructions.

Maximum storage temperature: 40°C (104°F)
Storage relative humidity: 5% to 85%, noncondensing
This device was designed for single patient use only. Do not reuse,

reprocess, or resterilize this product. Reuse, reprocessing, or
resterilization may compromise the structural integrity of the device
and/or create a risk of contamination of the device, which could result in
patient injury, illness, or death. Multiple uses can result in the occlusion
of the irrigation openings and affect the device’s performance. To prevent
this from occurring, the generator has the capability to detect previously
used ablation devices and will not allow their reuse.

It is the responsibility of the user to dispose of the devices in accordance
with local regulations and hospital procedures.

Due to the presence of phthalates in the product, the clinician must weigh
the medical benefits of product use against the drawbacks of phthalate
exposure for male children and pregnant or nursing women.

Connections to External Devices

1. Connection to the Cardioblate 68000 Generator is as follows:

a. Position the multi-pin connector of the bipolar device so the

alignment indicator matches the generator port indicator.

4 Instructions for Use English

b. Insert

1

2

the multi-pin connector of the bipolar device into the device
port on the generator until it locks in place. Do not force the
connection.

Note: If additional devices are to be used, refer to their specific
Instructions for Use.

2. Sterile normal saline, commercially available pressure cuff, and IV
tubing set are required for use with the bipolar device. These are not
included with the Cardioblate Gemini Surgical Ablation Device.

Instructions for Use

1. Inspect the package and device to ensure the expiration date has not
passed and damage has not occurred to the device during shipping
and handling. Do not use the device if the packaging or device is
damaged or if the expiration date has elapsed. Open the package
and transfer the contents onto the sterile field utilizing aseptic
technique.

2. Uncoil both the saline delivery tubing and the electrical cable carefully
to avoid kinking and tangling.

3. Attach the saline delivery tubing female luer connector to an IV tubing
set and 1000 mL bag of sterile normal saline. (0.9% normal saline is
recommended because it provides a low impedance pathway for the
radiofrequency energy to the tissue.)

4. Insert a 1000 mL bag of 0.9% normal saline into commercially
available pressure cuff and inflate to between 150 and 300 mm Hg.

5. Open the IV line and squeeze the handle to purge the system of air
until fluid is seen coming from the electrodes on the Gemini device.
Release the handle to stop IV flow.

1. 6.3 cm (2.49 in) Active
Electrodes

Guide Attachments

2.

Figure 2. Jaw/Electrode

6. Attach the Gemini electrical cable to the Cardioblate 68000
Generator per instructions outlined in “Connections to External
Devices.”

7. Optional: Navigator Guide Connection (Requires Cardioblate
Gemini Model 49261 and Cardioblate Navigator Model 68015)

Insert the surgical instrument guide (supplied with the

a.

Cardioblate Navigator) into the flexible guide attachment so the
tip is visible, then twist the guide lock clockwise to secure the
surgical instrument guide into place (Figure 3).

Figure 3. Insert Surgical Instrument Guide into Flexible Guide

b.

To remove the flexible guide attachment from the guide, firmly
grab the flexible portion of the guide attachment and pull away
from the guide (Figure 4).

Instructions for Use English 5

Figure 4.

8.

Connect the guides to the device (Figure 5) to assist in positioning
the electrodes on the targeted tissue.

Figure 5. Connect Jaw/Guide

Prior to tissue ablation:

9.
a. Squeeze the handle and make certain that saline is flowing freely

out of the electrodes. Continuous flow of saline is necessary
during ablation to cool the outer tissue. Cooling of the outer tissue
prevents charring and tissue desiccation and allows
radiofrequency energy to be delivered deeper into the tissue to
more effectively create transmural lesions.

Note: While irrigation increases the effectiveness of
radiofrequency ablation, ablating in a pool of fluid can have a
detrimental effect. Radiofrequency energy can shunt between
the 2 electrodes and the transmurality algorithm may be less
effective. Suctioning of excessive fluid at the ablation site is
recommended to prevent this from occurring.

b. Confirm the Cardioblate 68000 Generator is set to the bipolar

mode.

c. The mode of operation will default to the TRANSMURALITY

control mode.

d. In the TRANSMURALITY mode, all generator parameters will be

automatically adjusted.

10. Tissue Ablation:
a. Once the electrodes are correctly positioned, squeeze the handle

until the parallel jaws lock and the electrodes are in full contact
with the tissue. The locking mechanism built into the handle must
be fully engaged to ensure accurate transmurality readings.

b. The RF energy is activated in the device by either pressing the

RF energy button on the Cardioblate 68000 Generator display

6 Instructions for Use English

panel, squeezing the RF Trigger on the device, or using the foot

0

2

0

3

04

0

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06

07

08

0

9

0

01

0

2000

4000

6000

8000

10000

12000

14000

16000

18000

20000

0

1

5

1

02

5

2

03

53

04

54

05

1

3

2

3

1

switch provided with the generator. When using the RF Trigger,
the current flows between the electrodes only when the handle
is in the locked position.

Note: It is not necessary to disconnect the guides before tissue
ablation.

Table 1. Anticipated Energy Delivery at Various
Tissue Thicknesses

Tissue Thickness (6 cm length) Energy Delivered (W)

c. The lesion becomes visible by a white coloration on the tissue.

In TRANSMURALITY control mode, the Cardioblate 68000
Generator will emit a solid tone once a transmural lesion is
created. This is the indication to the surgeon to stop ablating by
releasing
RF energy button on the generator.

Note: Ablation times will vary due to tissue thickness but will not
exceed 45 seconds per ablation cycle.

Note: Ablating beyond recommended ablation times may result
in tissue perforation.

Note: To prevent the porous jaws from drying out and clogging,
maintain the jaws immersed in saline or covered with a wet
sponge between ablations.

2 mm 833 ±32
6 mm 889 ±135

10 mm 1023 ±163

the foot switch, releasing the RF trigger, or pressing the

1. Average Impedance (Ohms)

Time (msec)

2.

3. Power (Watts)

Corresponding Power Levels.

11. After tissue ablation:
a. Press

b. Disconnect the guides from the device (Figure 7).

12.

Upon completion of the surgical procedure, disconnect the device
from the generator and discard.

Clinical Data on Conduction Block

In vitro testing was conducted creating lesion sets on porcine atria.
In vivo testing was performed on porcine tissue using the Gemini

Figure 6. Typical Tissue

Impedance Values with

(Approximate total energy

delivered 570 W)

the handle lock release on the handle to unlock the parallel

jaws and allow the device to be retracted from the target tissue.

Figure 7. Disconnect Jaw/Guide

Instructions for Use English 7

device. Transmural lesions were demonstrated with a
95/95 confidence level. The tables below provide an example of
lesion depth, width, and length using the Gemini device:

In vitro lesion evaluation study
Cardiac Tissue

Max Transmurality Depth
(mm)

Lesion Length (cm) 4.1 ±0.6 6.0*
Lesion Width (mm) 4.5 ±0.4 2.9 ±1.1

*In vitro transmurality and length variables were controlled by tissue
cut to 3 mm thickness and full 6 cm bites, therefore there are no
standard deviations on soft tissue lesions.

In vivo lesion observations in a single por-

Cardiac

Tissue

Max Transmural­ity Depth (mm)

Lesion Length
(cm)

Lesion Width
(mm)

**Data was obtained in a nonstatistical sample size, in vivo porcine
study with 3 lesion burns in each tissue. The Gemini device can
achieve transmurality of up to 10 mm in cardiac tissue as
demonstrated in vitro.

These results are consistent with a small, retrospective study
conducted at 2 investigational centers of 69 patients during
2006-2007. Thirty-five of those patients received cardiac tissue

using the Medtronic Cardioblate system. Of the 35 patients,

ablation
29 (82.9%) underwent conduction block assessment confirming
transmurality of cardiac tissue lesions. The remaining 6 patients were
not assessed.

(n=3)

3.0 ±2.5** 6.5 ±1.9 7.4 ±2.9 8.5 ±2.4

3.8 ±0.6 3.8 ±1.0 5.3 ±0.4 4.8 ±1.0

4.3 ±1.2 5.7 ±2.0 5.4 ±1.0 3.6 ±1.3

(n=42)

5.6 ±1.2 3.0*

cine animal study

Pulmonary

Tissue

(n=3)

Hepatic

Tissue

(n=3)

Soft Tissue
(n=44)

Renal

Tissue

(n=3)

8 Instructions for Use English

The following disclaimer of warranty applies to United
States customers only:

Disclaimer of Warranty

ALTHOUGH THE CARDIOBLATE® GEMINI® SURGICAL ABLATION
DEVICE, HEREAFTER REFERRED TO AS “PRODUCT” HAS BEEN
MANUFACTURED UNDER CAREFULLY CONTROLLED
CONDITIONS, MEDTRONIC HAS NO CONTROL OVER THE
CONDITIONS UNDER WHICH THIS PRODUCT IS USED.
MEDTRONIC, THEREFORE DISCLAIMS ALL WARRANTIES, BOTH
EXPRESS AND IMPLIED, WITH RESPECT TO THE PRODUCT,
INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
MEDTRONIC
FOR ANY MEDICAL EXPENSES OR ANY DIRECT, INCIDENTAL OR
CONSEQUENTIAL DAMAGES CAUSED BY ANY USE, DEFECT,
FAILURE OR MALFUNCTION OF THE PRODUCT, WHETHER A
CLAIM FOR SUCH DAMAGES IS BASED UPON WARRANTY,
CONTRACT, TORT OR OTHERWISE. NO PERSON HAS ANY
AUTHORITY TO BIND MEDTRONIC TO ANY REPRESENTATION OR
WARRANTY WITH RESPECT TO THE PRODUCT.

The exclusions and limitations set out above are not intended to, and
should not be construed so as to, contravene mandatory provisions of
applicable law. If any part or term of this Disclaimer of Warranty is held
to be illegal, unenforceable or in conflict with applicable law, by a court
of competent jurisdiction, the validity of the remaining portions of this
Disclaimer
shall be construed and enforced as if this Disclaimer of Warranty did not
contain the particular part or term held to be invalid.

SHALL NOT BE LIABLE TO ANY PERSON OR ENTITY

of Warranty shall not be affected, and all rights and obligations

Instructions for Use English 9

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M940542A001 Rev. 1B