Endoscopy systems

PillCam™ COLON 2 system

<p>The PillCam™ COLON 2 capsule is intended for the visualization of the colon for diagnosis of colonic disorders.</p>

Indications, Safety, and WarningsThe material on this website should not be considered the exclusive source of information, it does not replace or supersede information contained in the device manual(s).Please note that the intended use of a product may vary depending on geographical approvals.See the device manual(s) for detailed information regarding the intended use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events.For a MRI compatible device(s), consult the MRI information in the device manual(s) before performing a MRI.If a device is eligible for eIFU usage, instructions for use can be found at Medtronic’s website manuals.medtronic.com.Manuals can be viewed using a current version of any major internet browser. For best results, use Adobe Acrobat® Reader with the browser.Medtronic products placed on European markets comply with EU and UK legislation (if applicable) on medical devices. For any further information, contact your local Medtronic representative.Medtronic medical devices marketed in Spain are in compliance with the Spanish legislation in force.

Features

Incomplete colonoscopies happen, but there’s another option — the PillCam™ COLON 2 system.

The PillCam™ COLON 2 capsule provides a potential solution for patients who need another option after an incomplete colonoscopy, allowing a complete examination in up to 97% of patients.⁵

Minimally invasive
visualization^1,2

Patient-friendly experience
without radiation^3,4

High-diagnostic yield
compared to CTC⁶

Explore the PillCam™ COLON 2 system components.

PillCam™ COLON 2 capsule

The PillCam™ COLON 2 capsule is a camera within a capsule that captures images as it travels through the colon.

Indications, Safety, and WarningsIndications

The PillCam™ COLON 2 capsule endoscopy system is intended to provide visualization of the colon.

It may be used for detection of colon polyps in patients after an incomplete optical colonoscopy with adequate preparation and a complete evaluation of the colon was not technically possible.

In addition, it is intended for detection of colon polyps in patients with evidence of gastrointestinal bleeding of lower Gl origin. This applies only to patients with major risks for colonoscopy or moderate sedation, but who could tolerate colonoscopy and moderate sedation in the event a clinically significant colon abnormality was identified on capsule endoscopy.

Contraindications

Patients with known or suspected GI obstruction, strictures, or fistulas based on the clinical picture or pre-procedure testing and profile

Patients with cardiac pacemakers or other implanted electro-medical devices

Patients with swallowing disorders

In patients with allergies or known contraindications to the medications and preparation agents used in the procedure as described in the relevant instructions for use

Procedure risk informationThe risks of PillCam™ COLON 2 capsule include capsule retention, aspiration, and skin irritation.The risks associated with colon preparation are allergies or other known contraindications to any preparation agents or medications used for the PillCam™ COLON 2 regimen, according to laxative medication labeling and per physician discretion.Medical, endoscopic, or surgical intervention may be necessary to address any of these complications, should they occur.After ingesting the PillCam™ COLON 2 capsule and until it is excreted, the patient should not be near any source of powerful electromagnetic fields such as one created near an MRI device.Please refer to the product user manual for detailed information.

PillCam™ recorder 3

The PillCam™ recorder 3 is a recording device with a built-in, real-time viewer, which is worn by the patient during the PillCam™ procedure. Following the procedure, the physician downloads the images from the PillCam™ recorder 3 for interpretation.

Indications, Safety, and WarningsIndications

The PillCam™ COLON 2 capsule endoscopy system is intended to provide visualization of the colon.

It may be used for detection of colon polyps in patients after an incomplete optical colonoscopy with adequate preparation and a complete evaluation of the colon was not technically possible.

Contraindications

Patients with known or suspected GI obstruction, strictures, or fistulas based on the clinical picture or pre-procedure testing and profile

Patients with cardiac pacemakers or other implanted electro-medical devices

Patients with swallowing disorders

In patients with allergies or known contraindications to the medications and preparation agents used in the procedure as described in the relevant instructions for use

PillCam™ COLON 2 sensor belt

The PillCam™ COLON 2 sensor belt is worn around the patient's waist over a single layer of clothing and can be adjusted to achieve the most comfortable fit.

Indications, Safety, and WarningsIndications

The PillCam™ COLON 2 capsule endoscopy system is intended to provide visualization of the colon.

It may be used for detection of colon polyps in patients after an incomplete optical colonoscopy with adequate preparation and a complete evaluation of the colon was not technically possible.

Contraindications

Patients with known or suspected GI obstruction, strictures, or fistulas based on the clinical picture or pre-procedure testing and profile

Patients with cardiac pacemakers or other implanted electro-medical devices

Patients with swallowing disorders

In patients with allergies or known contraindications to the medications and preparation agents used in the procedure as described in the relevant instructions for use

PillCam™ COLON 2 sensor array

The PillCam™ COLON 2 sensor array features an eight-lead sensor, which is placed on the patient’s body to receive transmission data from the PillCam™ COLON 2 capsule.

Indications, Safety, and WarningsIndications

The PillCam™ COLON 2 capsule endoscopy system is intended to provide visualization of the colon.

It may be used for detection of colon polyps in patients after an incomplete optical colonoscopy with adequate preparation and a complete evaluation of the colon was not technically possible.

Contraindications

Patients with known or suspected GI obstruction, strictures, or fistulas based on the clinical picture or pre-procedure testing and profile

Patients with cardiac pacemakers or other implanted electro-medical devices

Patients with swallowing disorders

In patients with allergies or known contraindications to the medications and preparation agents used in the procedure as described in the relevant instructions for use

PillCam™ software v9.0E

PillCam™ Desktop software processes and transforms the raw image data stored in the recorder into a conveniently viewable PillCam™ software video.

Indications, Safety, and WarningsIndications

The PillCam™ COLON 2 capsule endoscopy system is intended to provide visualization of the colon.

It may be used for detection of colon polyps in patients after an incomplete optical colonoscopy with adequate preparation and a complete evaluation of the colon was not technically possible.

Contraindications

Patients with known or suspected GI obstruction, strictures, or fistulas based on the clinical picture or pre-procedure testing and profile

Patients with cardiac pacemakers or other implanted electro-medical devices

Patients with swallowing disorders

In patients with allergies or known contraindications to the medications and preparation agents used in the procedure as described in the relevant instructions for use

PillCam™ capsule endoscopy software v9.0E

Top 100

Note: The top 100 features are not intended to detect pathology in lieu of a physician and should not be used as a substitute for reviewing the entire video.

Atlas images

Compare pathologies for a confident diagnosis.

GI map

GI mapping provides a graphical representation of the progress of the capsule through the small bowel and colon. This feature is available with both the PillCam™ sensor array and belt.

PillCam™ COLON 2 system is compatible with PillCam™ software generations V9.0E and newer. This allows you to interpret PillCam™ COLON 2 studies using the same interface and tools you’ve become accustomed to with PillCam™ small bowel capsules.

PillCam™ capsule endoscopy technology

Optimize tissue coverage with innovative technology.

An adaptive frame rate technology optimizes tissue coverage.
Extra wide 172-degree angle of view (344 degrees total) allows for nearly 360-degree coverage of the colon.⁴
The capsule transmits images to a recorder that connects to a belt or sensor array the patient wears, ensuring data collection.¹

Full reading training is available with the technology.

Ordering information

Item number	Description	Quantity
FGS-0517	PillCam™ COLON 2 capsule	1
FGS-0518	PillCam™ COLON 2 capsule	5
FGS-0519	PillCam™ COLON 2 capsule	10
FGS-0659	PillCam™ patency capsule	1
FGS-0660	PillCam™ patency capsule	5

Resources

FAQ: PillCam™ remote reading platform for HCP (open in new window)

The purpose of this document is to proactively provide responses to commonly asked questions regarding the PillCam™ remote reading platform for your medical staff.

PRODUCT PDF 108 KB