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25

20

15

10

5

0 to 40 55 to 6050 to 55 65 to 7060 to 65 75 to 8070 to 75 85 to 9080 to 85 95 to 100

2

90 to 9545 to 50

40 to 45

SVC Length in mm

Number of Patients

3

4

11

13 14

1616

22

23

4

SVC Tears Can Be Intra- and Extra-Pericardial

• The pericardium extends above the right atrium and covers

between 30-45% of the SVC.

• TEE may identify an intra-pericardial tear, but not recognize

the tear also extends above the pericardium in the SVC.

• Tears that extend into both areas can bleed into

pericardium and the right chest.

• Bleeding in the pericardium should not rule out a tear that

extends higher in the SVC.

SVC Anatomy & Bridge™ Deployment

Diagram of the pericardium covering about 1/3 of the SVC. The right atrium (RA)

and brachiocephalic vein (BC, also known as the innominate vein) are also shown for

reference.

“When in doubt, inate Bridge.”

- Dr. Roger Carrillo, MD. University of Miami

SVC lengths of patient population at University of Miami

93% of patients would be completely covered by the Bridge Balloon. The

remaining 7% of patients would be mostly covered by the 8cm Bridge Balloon.

Courtesy of Roger Carrillo, MD.

Bridge™ Occlusion Balloon has proven to be a life-saving technology.1

Procedural planning that considers superior vena cava (SVC) anatomy in

relation to the pericardium can help ensure successful deployment and

utilization.

93%

119 out of 128 patients had

SVC lengths that would be

completely covered by Bridge.

BC BC

RA

SVC

Pericardium

Bridge is designed to cover the entire length of the SVC,

including tears in the intra- and extra-pericardial space.

DEPLOYS IN

UNDER

2 MINUTES2

STOPS ON

AVERAGE 90%

OF BLOOD

LOSS3

30 MINUTES

OF ACCEPTABLE

HEMOSTASIS4

©2016 Spectranetics. All Rights Reserved. Approved for External Distribution. D032863-00 112016

“I cannot overstate that this is a tool that saves lives.1”

- Dr. Roger Carrillo, MD., University of Miami

References

1. Elrod, Jodia. Use of Bridge™ Occlusion Balloon in Lead Extraction: Interview with Dr. Roger Carrillo. EP Lab Digest.

November, 2016.

2. Document on le D027562. Bridge can be fully deployed in under one minute (53 seconds) in an animal model

when pre-positioned on a guidewire, or in under two minutes (1 minute, 46 seconds) when not pre-positioned.

3. Document on le D027561. When deployed, the Bridge occlusion balloon reduces blood loss by up to 90%, on

average, in an animal model of an SVC tear. Testing was conducted in a heparinzed porcine model which has

shorter SVC length than is typical in humans. A balloon design scaled for use specically in the porcine model was

used in generating this data.

4. Document on le, D026197. In an animal model with SVC tears up to 3.5 cm, with 2 pacing leads and 1 ICD lead.

Important Safety Information

INDICATIONS

The Bridge Occlusion Balloon Catheter is indicated for use for temporary

vessel occlusion of the superior vena cava in applications including

perioperative occlusion and emergency control of hemorrhage. Any use

for procedures other than those indicated in these instructions is not

recommended

CONTRAINDICATIONS

None known.

WARNINGS

Do not position the Bridge Occlusion Balloon Catheter in a manner that

would obstruct the right atrium. Obstruction of the atrium could lead to

arrhythmias and/or hemodynamic compromise.

Prior to initiating the lead extraction procedure, a Bridge Occlusion Balloon

Catheter compatible guidewire should be placed through a venous access

site and across the length of the superior vena cava. Attempting to place a

compatible guidewire after a venous tear occurs may result in an inability to

traverse the superior vena cava with the guidewire, result in the guidewire

Always Reaching Farther

Corporate Headquarters

The Spectranetics Corporation

9965 Federal Dr., Colorado Springs, CO 80921

Tel: 719-447-2000 • Fax: 719-447-2022

Customer Service: 800-231-0978

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Spectranetics Deutschland GmbH

Schweinfurter Str. 7

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Phone: +49 931/4520080 • Fax: +49 931/45200811

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Plesmanstraat 6, 3833 LA Leusden

The Netherlands

Tel: +31 33 4347 050 • Fax: +31 33 4347 051

exiting the vasculature at the tear site, result in an inability to place the Bridge

Occlusion Balloon Catheter or delay or prevent the ability to achieve occlusion.

Lead extraction should be performed at institutions with cardiothoracic

surgical capabilities by physicians knowledgeable in the techniques

and devices for lead or catheter removal. Complication prevention and

management protocols should be in place and routinely practiced. It is strongly

suggested that the recommendations for lead management of the Heart

Rhythm Society (HRS) and European Heart Rhythm Association (EHRA) be

followed for best results.

Failure to observe recommended ination techniques may result in formation

of contrast crystals which could prevent deation. Do not over-inate the

Bridge Occlusion Balloon Catheter after fully occluding the vessel. Over

ination may result in damage to the vessel Do not exceed the Maximum

Ination Volume. Over ination may result in damage to the vessel or rupture

of the balloon. Occlusion of the superior vena cava beyond 30 minutes is

not recommended as this may increase the risk of adverse physiologic or

neurologic complications.

Refer to the IFU for additional information.