Product Portfolio - Gastroenterology

Whether it’s esophageal disease, liver cancer, Crohn’s disease, colorectal disease, or other gastrointestinal diseases, you need solutions that improve patient outcomes.

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Colorectal disease
Esophageal and gastric
EUS and ablation
GI bleeding and chronic disease

Colorectal disease products

We're putting patients at the center of our solutions, from artificial intelligence colonoscopy to a minimally invasive vitamin-sized pill, which both aid in the detection of colon polyps. Our solutions are designed to help you detect and treat disease in its early stages — that’s the path to better outcomes.

Featured product

GI Genius™ intelligent endoscopy module

The GI Genius™ intelligent endoscopy module offers a transformative solution − powered by artificial intelligence − assisting physicians in the detection of colorectal polyps regardless of shape, size, and morphology.¹

Learn about GI Genius™

Indications, Safety, and WarningsIndicationsGI Genius™ intelligent endoscopy module is a computer-assisted reading tool designed to aid endoscopists in detecting colonic mucosal lesions (such as polyps and adenomas) in real time during standard white light endoscopy examinations of patients undergoing screening and surveillance endoscopic mucosal evaluations. The GI Genius™ computer-assisted detection device is limited for use with standard white-light endoscopy imaging only. This device is not intended to replace clinical decision making.Contraindications and warningsGI Genius™ system is intended to be used as an adjunct to colonoscopy procedures and is not intended to replace endoscopist assessment or histopathological sampling. GI Genius™ system does not make any elaboration or alteration of the colonoscopy video streaming, it only overlays graphical markers.

Danger: Do not use this system for any purpose other than its intended use.

Danger: The system does not perform any diagnosis.

Caution: The sale, distribution, and the use of the GI Genius™ system are restricted to prescription use in accordance with 21 CFR 801.109.

Caution: The device is not intended to be used as a stand-alone diagnostic device.

Caution: The device is not intended to characterize lesions in a manner that would potentially replace biopsy sampling.

Caution: The device is not intended to replace clinical decision-making.

Caution: The device is not intended to be used with equipment that was not tested against it during validation activities.

Caution: The device has not been studied in patients with inflammatory bowel disease (IBD), history of CRC, or previous colonic resection. The device performance may be negatively impacted by mucosal irregularities such as background inflammation from certain underlying disease.

Caution: Users should be aware, when using automated systems such as the GI Genius™ that provide assistance in identifying suspicious lesions, that a high level of reliance may be placed on the system output, potentially leading to user complacency and a bias towards accepting the system output results, rather than using the device as intended. The device is intended to provide adjunctive information to the endoscopist who performs endoscopic evaluations with an expected high level of clinical expertise. Placing too much reliance on the system in this way may lead to an unacceptably low level of procedural oversight (situational awareness), sub-par evaluation of the patient, and eventual endoscopist skill degradation, following which retraining may be necessary.

Danger: Using incompatible equipment can result in patient injury or equipment damage and makes it impossible to obtain the expected functionality.

RisksElectrical risks

Danger: Observe the following precautions. Failure to do so may place the patient and medical personnel in danger of electric shock. Keep fluids away from the system. If fluids are spilled on or into the system, immediately stop any operation of the system. If fluids are spilled on or into the system, immediately stop any operation of the system and contact support.

Danger: Do not use the system when not properly closed. Do not touch electrical contacts inside any component of the system.

Fire or explosion risks

Danger: In order to prevent fire and explosion, do not expose the system where:

There is a high concentration of oxygen
Air contains oxidizing agents (e.g., n2o)
Air contains any flammable gases
There are flammable liquids nearby

Interferences

Warning: System may interfere with other equipment.

Caution: Electromagnetic interference may occur to this instrument when it is placed near equipment marked with the following symbol electromagnetic interference symbol

or other portable and mobile RF communications equipment such as cellular phones. If radio interference occurs, mitigation measures may be necessary, such as reorienting or relocating this instrument or shielding the location. Do not use GI Genius™ system and its cables closer than 30 cm (12 inches) to the equipment with the following symbol electromagnetic interference symbol

Electromagnetic fields

Warning: Do not use the system where there is a strong electromagnetic field (e.g., magnetic resonance, wireless devices, microwave-emitting devices).

Mechanical forces

Caution: While pressing buttons or touching the system, do not use hard or pointed objects or apply excessive force otherwise damage to the equipment will occur.

Connection and disconnections

Caution: Do not connect/disconnect any cable of the system while any component is powered on, otherwise damage to the equipment will occur.

PillCam™ COLON 2 system

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

Esophageal and gastric products

Today, patients with esophageal diseases face an increasingly complex journey on their path to better outcomes. Solving this challenge requires a radically simple approach — detect their disease early, and treat it early.

Endoscopy is not enough.

It’s time to transform the standard of esophageal care for your patients. In the United States, 50% of endoscopies for predominant esophageal symptoms are inconclusive. This can lead to a continual cycle of tests and a long road to diagnosis.²

Our comprehensive solutions can assist you in potentially assessing and treating esophageal patients by allowing you to:

Determine the root cause of symptoms — potentially all in one single encounter
Evaluate esophageal disorders objectively
Personalize your approach to patient management

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Inform patient management

50%

of endoscopies for predominant esophageal symptoms²

are inconclusive

Featured product

Endoflip™ 300 impedance planimetry system

The Endoflip™ 300 impedance planimetry system measures pressure and dimensions in real-time to aid in the evaluation of major motility disorders.³

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Indications, Safety, and WarningsIndications for useIncluding the FLIP™ topography moduleThe Endoflip™ system is indicated for use in a clinical setting to measure pressure and dimensions in the esophagus, pylorus, and anal sphincters in adults and to measure pressure and dimensions in the esophagus, in patients from five years of age. It is intended to be used as an adjunct to other diagnostic methods as part of a comprehensive evaluation of patients with symptoms consistent with gastrointestinal motility disorders.
ContraindicationsSpecific to the FLIP™ topography module

The Endoflip™ system is contraindicated where endoscopy is contraindicated.

The Endoflip™ system is contraindicated for use in patients with actively bleeding varices in the esophagus.

Potential complicationsPotential complications include:

Allergic reaction

Anaphylaxis

Bleeding

Cardio-respiratory complications

Dental trauma

Infection

Pain

Perforation

Pulmonary aspiration

Vasovagal response

Warnings

Federal law (United States) restricts this catheter to sale by, or on the order of, a physician.

To reduce the risk of electric shock, always disconnect the device from AC power before opening the enclosure.

Do not use the device if any damage to the AC power cord (such as frayed wires, cracks, or cut insulation) is evident.

Do not use the device if the touchscreen is not functioning correctly or is not clearly readable.

Do not use this device if an error condition cannot be corrected.

The Endoflip™ system should be mounted on a flat stable surface. When in use, keep the catheter and power cord stowed or positioned in a safe manner in order to avoid a tripping or snagging hazard.

Do not allow the air inlet at the side of the unit or ventilation ports at the rear to become covered or obstructed.

Use the Endoflip™ system only with the supplied power adapter (part number EF-500). Do not use the device if any damage to the power adapter (such as frayed wires, cracks, or cut insulation) is evident. The power adapter is not field-serviceable.

Medical electrical equipment requires special precautions regarding electromagnetic compatibility (EMC) and must be installed and put into service according to the EMC information provided in this instructions for use (see Appendix B: Specifications).

Before using the Endoflip™ system on a patient, allow the device to acclimate to conditions of use following transport or storage.

Do not insert the syringe into the Endoflip™ system before connecting power or powering on.

Use the Endoflip™ system on a patient when in normal or barostat operating mode only. Do not attach to the patient during power on self-test (POST) or in service mode. Maintain continuous observation of the patient during use.

In the unlikely event that the Endoflip™ system stops normal operation during a procedure, use the back panel on/off switch to turn the unit off, remove the syringe from the unit and retract the syringe plunger manually to withdraw any remaining fluid from the balloon catheter. The catheter can then be carefully removed from the patient.

Use the Endoflip™ system only with parts and accessories approved by Covidien.

Do not place fingers or hands near the syringe drive system when it is moving.

Service on this device should be performed only by a qualified service technician.

To ensure proper operation, do not make unauthorized modifications to the device.

Transport, set up, and store the device so that it does not pose a tripping hazard.

Use proper technique for lifting the device.

To minimize the risk of puncturing or damaging the device, do not use sharp objects on the touchscreen.

This equipment is not suitable for use in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide. To minimize the risk of fire, use this device in well-ventilated areas away from flammable anesthetics.

To minimize the risks associated with excess inflation pressure, observe the patient and all alarms during use, and refer to the display to observe diameters and pressure during a procedure, and while making settings or setting changes.

Verify that there are no leaks in the catheter during the purge cycle.

During operation, check that the amount of fluid in the syringe matches the amount shown onscreen and verify that the syringe refills as indicated when the plunger aligns with the arrow on the syringe (indicating that the balloon is empty) before carefully removing the catheter from the patient.

Replace the catheter if a Dest value remains consistently at a maximum or minimum compared to adjacent Dest values; this can indicate a faulty catheter.

Do not use this device near magnetic resonance imaging (MRI).

For accurate measurements, high-frequency devices such as electro-surgery or diathermy/cautery equipment should be deactivated.

Remove the catheter if the patient requires defibrillation.

Display devices and their adapters connected to the VGA connector of the Endoflip™ system must meet the requirements of IEC 60601-1 and be located in the same room where the Endoflip™ system is being used.

The Endoflip™ system must be connected to a wall outlet or a single-outlet extension only. Do not use multiple-outlet sockets other than outlets approved by Covidien.

Install all equipment according to applicable national wiring requirements.

If used in conjunction with endoscopy equipment, the leakage current from the Endoflip™ system catheter may be additive to the leakage current from the endoscope.

When using a catheter with integrated pressure sensor, for optimal pressure measurements, do not expose the balloon portion of the catheter to excessive light during operation.

Do not make a connection to the rear USB port when Endoflip™ is connected to a patient.

To ensure proper operation and to minimize the risk of patient injury, only use the pre-filled syringe supplied with the catheter. Different catheter part numbers are supplied with different solution concentrations.

To avoid the risk of personal injury, place the Endoflip™ unit on a flat, stable surface. Do not attempt to lean on or use the Endoflip™ system for support.

Connect the Endoflip™ system to power and turn the device on before installing the syringe to the system.

Before use, inspect the catheter assembly from end to end for breakage, occlusions, or debris. Do not use if damage to the parts or packaging is evident, or if any portion of the catheter packaging has been previously opened. Do not use any part after its expiration date or if the expiration date cannot be verified.

Cautions

Use a unique ID for each patient. Re-entering the previously-entered ID causes previous information to be overwritten when archiving patient data.

An automatic pressure zero occurs at the beginning of the catheter pre-use check. Following the pressure zero, observe that the pressure reading increases above 10mmHg during the pre-use check. Otherwise, the catheter may be faulty and should be replaced.

To avoid internal part corrosion, do not use chlorine bleach on the touchscreen.

Warnings and cautions

Do not use this module if an error condition cannot be corrected.

Refer to the Endoflip™ system instructions for use for warnings and cautions related to the system.

Indications for useEndoflip™ EF-322N and EF-325N cathetersThe Endoflip™ system is indicated for use in a clinical setting to measure pressure and dimensions in the esophagus, pylorus, and anal sphincters in adults and to measure pressure and dimensions in the esophagus, in patients from five years of age. It is intended to be used as an adjunct to other diagnostic methods as part of a comprehensive evaluation of patients with symptoms consistent with gastrointestinal motility disorders.ContraindicationsEndoflip™ EF-322N and EF-325N catheters

The Endoflip™ system is contraindicated where endoscopy is contraindicated.

Do not use the Endoflip™ system on patients with actively-bleeding varices in the esophagus.

The EF-322N catheter is not suitable for diameter measurements less than 5 mm.

The EF-325N catheter is not suitable for diameter measurements less than 5 mm.

Potential complicationsPotential complications include:

Allergic reaction

Anaphylaxis

Bleeding

Cardio-respiratory complications

Dental trauma

Infection

Pain

Perforation

Pulmonary aspiration

Vasovagal response

Warnings

Do not reuse, reprocess, or sterilize. Reuse, reprocessing or sterilization can compromise the structural integrity of the device; impair performance accuracy due to residual fluid in the balloon and degrade the catheter markings.

Federal law (United States) restricts this catheter to sale by, or on the order of, a physician.

All catheter components are intended for single patient use only; do not attempt to reuse. Follow all applicable federal and local regulations for disposal or recycling.

To ensure proper operation and to minimize the risk of patient injury, do not attempt to add or remove fluid from the supplied pre-filled syringes. Only use the pre-filled syringe supplied with the catheter.

Note: Different catheter part numbers are supplied with different solution concentrations.

To avoid damaging the catheter and syringe, store away from sources of heat in specified environmental conditions (see Appendix A: Specifications).

Before using the Endoflip™ system and catheter on a patient, allow the device to acclimate to conditions of use following transport or storage.

During operation, check that the amount of fluid in the syringe matches the amount shown onscreen, and verify that the syringe refills, as indicated when the plunger aligns with the arrow on the syringe (indicating that the balloon is empty) before carefully removing the catheter from the patient.

Verify that there are no leaks in the catheter during the pre-use purge cycle described in the Endoflip™ system instructions for use.

Replace the catheter if a Dest value remains consistently at a maximum or minimum compared to adjacent Dest values; this can indicate a faulty catheter.

Remove the catheter if the patient requires defibrillation.

For optimal pressure measurements, do not expose the balloon portion of the catheter to excessive light during the procedure.

Before use, inspect the catheter assembly from end to end for breakage, occlusions, or debris. For single use devices, do not use if damage to the parts or packaging is evident, or if any portion of the package has been previously opened. Do not use any part after its expiration date or if the expiry date cannot be verified.

Avoid using excessive force during insertion. Withdraw the catheter if resistance is too high.

Refer to the Endoflip™ system instructions for use for warnings related to the system.

Cautions

Refer to the Endoflip™ system instructions for use for cautions related to the system.

Notice to the user and/or patient: Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the member state in which the user and/or patient is established.Instructions for use part numbers

Endoflip™ impedance planimetry system – PT00127746 Rev A 2020-09

FLIP™ topography module – PT00127747 Rev A 2020-09

Endoflip™ EF-322N catheter – PT00124050 Rev A 2020-09

Endoflip™ EF-325N catheter – PT00124053 Rev A 2020-09

EUS and ablation products

We provide predictable tools and treatments so you can optimize your clinical approach for your patients - no matter how complex. We’re committed to partnerships with interventional radiologists, pathologists, oncologists, surgeons, and the GI community for proactive GI care.

Achieve more with EUS

Three interchangeable needles — the FNA, FNB, and FNF — allow for fine needle aspiration, fine needle biopsy, and fiducial placement. They are designed for improved procedural workflow in one procedure.^4-11

Risk information

The six distal cutting edges of the SharkCore™ FNB needle are specifically designed to obtain cohesive units of tissue with intact cell architecture.^12-15
The Beacon™ FNA needle, an interchangeable component of the Beacon™ EUS delivery system, is designed to improve tissue yield.^4,16-17
The Beacon™  FNF  needle, pre-loaded with two solid gold markers, helps simplify the procedure, and reduces overall procedure time.¹⁸

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GI bleeding and chronic disease products

We’re committed to developing meaningful innovations for GI bleeding and chronic diseases, designed to improve outcomes. We help patients with GI bleeding and chronic diseases by providing technologies to help physicians diagnose and treat their diseases.

PillCam™ SB 3 system

The PillCam™ SB 3 system may be used in direct visualization and monitoring of lesions that may be related to Crohn’s disease, obscure bleeding, or iron deficiency anemia not detected by upper and lower endoscopy.

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Indications, Safety, and WarningsPillCam™ SB 3 capsuleIndications for useThe PillCam™ SB 3 capsule is intended for visualization of the small bowel mucosa and:

May be used in the visualization and monitoring of lesions that may indicate Crohn’s disease not detected by upper and lower endoscopy

May be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy

May be used in the visualization and monitoring of lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy

The PillCam™ SB 3 capsule may be used as a tool in the detection of abnormalities of the small bowel and is intended for use in adults and children from two years of age.

The suspected blood indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas.

ContraindicationsContraindications for the PillCam™ SB 3 capsule include:

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

Patients with cardiac pacemakers or other implanted electromedical devices.

Patients with dysphagia or other swallowing disorders.

Procedure risk information

The risks of the PillCam™ SB 3 capsule include capsule retention, aspiration, obstruction, perforation, and mucosal injury or bleeding.

Endoscopic placement may present additional risks.

Medical, endoscopic, or surgical intervention may be necessary to address any of these complications, should they occur.

After ingesting the PillCam™ SB 3 capsule, and until it is excreted, patients 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™ patency capsuleIndications for use

The PillCam™ patency capsule is an accessory to the PillCam™ video capsules and is intended to verify adequate patency of the gastrointestinal tract prior to administration of the PillCam™ video capsules in patients with known or suspected strictures.

The PillCam™ patency capsule should only be used within the specified patient age range based on the patient age of the indicated video capsule system.

Therefore, the PillCam™ patency capsule is intended to be used:

Prior to PillCam™ SB capsule in adults and children from two years of age, or

Prior to PillCam™ UGI, COLON, and Crohn’s capsules in adults

ContraindicationsContraindications for the PillCam™ patency capsule include:

Patients with swallowing disorders.

Procedure risk information

The risks of the PillCam™ patency capsule include capsule retention and aspiration.

Endoscopic placement may present additional risks.

Medical, endoscopic, or surgical intervention may be necessary to address any of these complications, should they occur.

After ingesting the PillCam™ patency capsule and until it is excreted, patients should not be near any source of powerful electromagnetic fields, such as one created near an MRI device.

Passage of an intact patency capsule does not preclude the presence of an intestinal stricture or other pathology.

Please refer to the product user manual for detailed information.

Medical education and resources

We are committed to delivering educational solutions aimed at helping you achieve procedural and clinical proficiency.

VIsit Medtronic Academy

Patient resources

Learn about who is at risk for colorectal cancer and how an early diagnosis can help.

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GI product portfolio

Colorectal disease products

Featured product

GI Genius™ intelligent endoscopy module

Esophageal and gastric products

Featured product

Endoflip™ 300 impedance planimetry system

EUS and ablation products

Featured product

Achieve more with EUS

GI bleeding and chronic disease products

Featured product

PillCam™ SB 3 system

Medical education and resources

Patient resources

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