PillCam™ SB 3 Capsule

Product Details

The PillCam™ SB 3 system allows for direct visualization of the small bowel, supporting greater confidence when monitoring lesions3 that may be related to GI bleeding, iron deficiency anemia, or Crohn's disease. The system features advanced optics and imaging designed to deliver exceptional images of the mucosa.

This system includes innovative features like adaptive frame rate technology, which supports image acquisition that is uniquely suited to each patient's motility, as well as the tools you need to record and interpret study results. The software contains our most advanced algorithms, providing you with the tools you need to efficiently read and interpret study results.

Specifications

Indications for Use

The PillCam™ Platform with a PillCam™ SB capsule is intended for visualization of the small bowel mucosa.

  • PillCam™ Platform with PillCam™ SB capsule may be used in the visualization and monitoring of lesions that may indicate Crohn’s disease not detected by upper and lower endoscopy.
  • PillCam™ Platform with PillCam™ SB capsule 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.
  • PillCam™ Platform with PillCam™ SB capsule 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 Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas.

The PillCam™ Platform with PillCam™ SB capsules 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.

Contraindications

The PillCam™ SB capsules are contraindicated for use under the following conditions:

  • In patients with known or suspected gastrointestinal obstruction, strictures, or fistulas based on the clinical picture or pre-procedure testing and profile.
  • In patients with cardiac pacemakers or other implanted electromedical devices.
  • In patients with swallowing disorders.

Note: The SB PillCam™ Capsule may be deployed by using transendoscopic delivery in patients who are either unable to ingest the PillCam™ capsule or are known to have slow gastric emptying time. Placement into the duodenum is recommended to prevent the patient from vomiting the capsule.

Procedure Risk Information

The risks of PillCam™ SB 3 capsule include capsule retention, aspiration, and skin irritation.

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.

Order Information
Order Code Description Unit of Measure Quantity
FGS-0391 PillCam™ SB 3 Capsule Pack 1
FGS-0395 PillCam™ SB 3 Capsule Pack 5
FGS-0400 PillCam™ SB 3 Capsule Pack 10

PillCam™ Crohn’s Capsule

Product Details

The PillCam™ Crohn’s platform is the only product that allows physicians to directly and non-invasively visualize the small bowel and colon in a single procedure, potentially reducing the number of exams and making disease management more convenient.

  • 172 degree field of view (per camera)
  • No sedation
  • No radiation

Comprehensive Visualization

  • Advanced optics and innovative imaging features allow for a thorough evaluation of Crohn’s disease activity and mucosal healing
  • Adaptive Frame Rate (AFR) technology increases the rate of image capture from 4 to 35 frames per second based on the speed of the capsule

Specifications

Indications

The PillCam™ Crohn’s capsule is intended for visualization of the small bowel and colonic mucosa.

  • It may be used in the visualization and monitoring of lesions that may indicate Crohn’s disease.
  • It may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult).
  • It may be used in the visualization and monitoring of lesions that may be potential causes of iron deficiency anemia (IDA).

The PillCam™ Crohn’s capsule may be used as a tool in the detection of abnormalities of the small bowel and colon. It is intended for use in adults and children from eight years of age.

Contraindications

The PillCam™ Crohn’s video capsule is contraindicated for use under the following conditions:

  • In patients with known or suspected gastrointestinal obstruction, strictures, or fistulas based on the clinical picture or pre-procedure testing and profile.
  • In patients with cardiac pacemakers or other implanted electromedical devices.
  • In patients with swallowing disorders.

Note: The procedure may involve intake of laxatives and prokinetic agents. Refer to the labeling of these agents for their contraindications.

Procedure Risk Information

The risks of the PillCam™ Crohn’s 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™ Crohn’s system 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™ Crohn’s capsule, and until the capsule 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.

Order Information
Order Code Description Unit of Measure Quantity
FGS-0606 PillCam™ Crohn’s Capsule Pack 1
FGS-0607 PillCam™ Crohn’s Capsule Pack 5
FGS-0608 PillCam™ Crohn’s Capsule Pack 10

PillCam™ COLON 2 Capsule

Product Details

Achieve direct visualization of the colon with the PillCam™ COLON 2 system. This innovative capsule endoscopy solution provides clear images of the colon to support detection of polyps with a noninvasive, patient-friendly device.

With innovative features like adaptive frame rate technology, advanced optics, and an extra-wide angle of view, this system has proven accuracy for detecting colon polyps.([FOOTNOTE=Eliakim R, Yassin K, Niv Y, Metzger J, Lachter J, Gal E, et al. Prospective multicenter performance evaluation of the second-generation colon capsule compared with colonoscopy. Endoscopy. 2009 Dec;41(12):1026-31.],[ANCHOR=],[LINK=]), ([FOOTNOTE=Spada C, Hassan C, Munoz-Navas M, Neuhaus H, Deviere J, Fockens P, et al. Second Generation PillCam™ COLON Capsule Compared with Colonoscopy. Gastrointest Endosc. 2011;74(3):581-589.],[ANCHOR=],[LINK=])([FOOTNOTE=User Manual (DOC-2044-02, March 2013), page 19.],[ANCHOR=],[LINK=]).

Specifications

Indications

  • The PillCam Capsule Endoscopy System with the PillCam COLON capsule is intended for the visualization of the colon for diagnosis of colonic disorders.
  • The PILLCAM™ COLON capsule is intended for use in adults and children from 8 years of age.

Contraindications

The PILLCAM™ COLON 2 video capsule is contraindicated for use under the following conditions:

  • In patients with known or suspected gastrointestinal obstruction, strictures, or fistulas based on the clinical picture or pre-procedure testing and profile.
  • In patients with cardiac pacemakers or other implanted electromedical devices.
  • In patients with swallowing disorders.

Note: The procedure may involve intake of laxatives and prokinetic agents. Refer to the labeling of these agents for their contraindications.

Procedure Risk Information

  • The 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.
Order Information
Order Code Description Unit of Measure Quantity
FGS-0517 PillCamTM COLON 2 Capsule Pack 1
FGS-0518 PillCamTM COLON 2 Capsule Pack 5
FGS-0519 PillCamTM COLON 2 Capsule Pack 10

PillCam™ Patency Capsule

Product Details

The PillCam™ patency capsule is a dissolvable capsule that provides a simple and convenient way to verify adequate patency of the gastrointestinal tract prior to PillCamTM capsule endoscopy. In patients with known or suspected strictures, a PillCam™ patency capsule may be given to help physicians assess if capsule endoscopy is a good option.

  • Dissolvable and biocompatible · Lactose body with 10% barium enables fluoroscopy visualization
  • Timer plugs facilitate controlled disintegration of capsule body
  • Now compatible with PillCamtm SB 3, PillCam COLON 2 and PillCam Crohn’s
  • The PillCam™ Patency Capsule is recommended to detect strictures prior to the procedure([FOOTNOTE=May A. et al., Kapselendoskopie in der Diagnostik von Dünndarmerkrankungen Update des Positionspapiers der Sektion Endoskopie der DGVS, Stand 07/2010, Z Gastroenterol 2010;48: 384–1404. Ladas S. D. et al., European Society of Gastrointestinal Endoscopy (ESGE): Recommendations (2009) on clinical use of video capsule endoscopy to investigate small-bowel, esophageal and colonic diseases, Endoscopy 2010; 42: 220–227.],[ANCHOR=],[LINK=])

Specifications

Indications

The PillCam™ patency system is an accessory to the PillCam™ video capsule and is intended to verify adequate patency of the gastrointestinal tract prior to administration of the PillCam™ video capsule in adults and children from two years of age with known or suspected strictures.

Contraindications

  • The PillCam™ patency capsule is contraindicated for use in patients with swallowing disorders.
  • The PillCam™ patency scanner is contraindicated for use in patients with cardiac pacemakers or other implanted electro medical devices.

The capsule is made of Lactose anhydrous, Barium sulphate, Magnesium stearate, Citric acid, Sodium bicarbonate, Avicel PH 200, Compritol 888, PVP K-90. The PillCam patency capsule should not be administered to patients who are hypersensitive to any component.

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
Order Information
Order Code Description Unit of Measure Quantity
FGS-0659 PillCam™ Patency Capsule EU Pack 1
FGS-0660 PillCam™ Patency Capsule Pack 5