ReShape™ Integrated Dual Balloon System Instructions for Use
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
DEVICE DESCRIPTION
The ReShape™ Integrated Dual Balloon System is a temporary implant designed to facilitate weight loss by occupying space in the stomach. The implant consists of two independently inflated, non-communicating, silicone balloons tethered to a central silicone shaft. It is inserted transorally down the esophagus into the stomach, with endoscopic guidance via a delivery catheter. When inflated, the ReShape Integrated Dual Balloon is designed to occupy a significant portion of the stomach while conforming to the natural shape of the patient’s anatomy.
The device’s flexible dual balloon design is intended to improve patient comfort while reducing the risk of device migration into the intestine. The maximum placement period for the ReShape Dual Balloon is 6 months, and it must be removed at that time or earlier.
At the conclusion of treatment, the ReShape Dual Balloon is aspirated using the ReShape Removal Catheter and removed endoscopically.
Figure 1. ReShape Dual Balloon in the Stomach
CONTRAINDICATIONS
Prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal
adhesions.
Prior open or laparoscopic bariatric surgery.
Any inflammatory disease of the gastrointestinal tract including esophagitis, gastric ulceration, duodenal
ulceration, cancer or specific inflammation such as Crohn’s disease.
Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or
acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias
or stenoses.
A gastric mass.
A hiatal hernia > 5 cm or ≤ 5 cm with associated severe or intractable gastro-esophageal reflux symptoms.
A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede
passage of the delivery catheter and/or an endoscope.
Achalasia or any other severe esophageal motility disorder that may pose a safety risk during the removal of
the device
Severe coagulopathy
Hepatic insufficiency or cirrhosis
Serious or uncontrolled psychiatric illness or disorder that could compromise patient understanding of or
compliance with follow up visits and removal of the device after 6 months.
Alcoholism or drug addiction.
Patients unwilling to participate in an established medically-supervised diet and behavior modification
program, with routine medical follow-up.
Patients receiving daily prescribed treatment with aspirin, anti-inflammatory agents, anticoagulants or other
gastric irritants.
Patients who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of
the device implant.
Patients who are known to have, or suspected to have, an allergic reaction to materials contained in the
system.
Patients who have ever developed a serotonin syndrome and are currently taking any drug known to affect
the levels of serotonin in the body [e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin-
norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs)] should not undergo
placement of the device.
Patients who are pregnant or breast-feeding.
WARNINGS
Intestinal obstructions have been reported due to deflated balloons passing into the intestines and have
required surgical removal. Death due to intestinal obstruction is possible and has been reported with other
intragastric balloons. Patients experiencing any symptoms of an intestinal obstruction (e.g., acute onset of
abdominal pain, nausea or vomiting) should be counseled to seek immediate care.
The maximum placement period for the ReShape Dual Balloon is 6 months. The risk of intragastric balloon
deflation and intestinal obstruction (and therefore possible complications related to intestinal obstruction) is
significantly higher when balloons are left in place longer than 6 months.
Patients with known abdominal adhesions or who have had prior abdominal surgery or have any signs or
symptoms of a bowel obstruction should be carefully evaluated prior to use of the ReShape Dual Balloon in
relation to possible intestinal obstruction should the device deflate or pass into the intestines. The risk of
intestinal obstruction may be higher in patients who have had prior abdominal surgery.
The ReShape™ Valve Sealant is necessary to seal the device valves and prevent balloon leakage. Failure
to use the specified amount of Valve Sealant will result in balloon leakage and deflation, and increase the
risk of intestinal obstruction (and therefore possible complications related to intestinal obstruction).
The presence of blue-green urine or sudden loss of satiety, increased hunger and/or weight gain may be a
sign of balloon deflation. Patients should be instructed to immediately contact their physician if they observe
any of these signs. Clinical means of assessing possible deflation include abdominal ultrasound, barium
swallow and endoscopy.
Patients may not observe or report the presence of blue-green urine following a balloon deflation. Patients
should be counseled to seek immediate care if any symptoms of an intestinal obstruction such as acute
abdominal pain, nausea or vomiting develop.
Partially (i.e., one balloon) or fully (i.e., both balloons) deflated devices must be removed promptly. The risk
of intestinal obstruction (and therefore possible complications related to intestinal obstruction) is significantly
higher when deflated devices are not removed promptly.
Failure of patients to take prescribed daily proton-pump inhibitor medication increases the risk of gastric
ulceration or perforation.
Using direct endoscopic visualization, confirm proper positioning of the uninflated balloons in the stomach
prior to inflation. Failure to do so may cause injury to the esophagus, pylorus or duodenum.
Patients receiving serotonergic drugs including SSRIs, SNRIs, MAOIs and other prescription and over-the-
counter drugs should be cautioned about the possibility of developing serotonin syndrome because of the
combination of these medications and the release of methylene blue (in the event of balloon rupture).
Patients should immediately seek medical attention if they develop any symptoms of confusion, headache,
nausea and vomiting, rapid heart rate, or severe sweating. Serotonin syndrome has been reported in
patients given serotonergic psychiatric medications and methylene blue via intravenous administration of
methylene blue at doses ranging from 1 mg/kg to 8 mg/kg.
In the event of balloon rupture, methylene blue would be released into the stomach and absorbed into the
circulation. Methylene blue is a drug with multiple pharmacological indications. Methylene blue is a DNA
binding agent that tests positive for mutagenicity and DNA damage in bacteria, yeast, mammalian cells, and
human tissue obtained after clinical exposures. The internal release of methylene blue would result in a local
concentration that is higher than that delivered by the usual IV injection route. The consequences of
transient acute methylene blue exposure following balloon rupture are not known.
Patients should immediately notify their doctor if they become pregnant while the device is in place, as there
is a risk for release of methylene blue and birth defects (in the event of balloon rupture). An association
exists between the use of methylene blue in amniocentesis and birth defects.
PRECAUTIONS
It is the responsibility of the physician to advise the patient of known risks and complications associated with
the procedure and the device.
It is the responsibility of the physician to advise the patient of the potential need to remove the device in less
than 6 months due to balloon deflation or GI intolerance.
It is the responsibility of the physician to advise the patient that the maximum placement period for the
ReShape Dual Balloon is 6 months and it must be removed at that time or earlier.
Patients must be counseled on the need for proper dietary and exercise habits. Failure to adhere to
prescribed dietary and exercise instructions may result in failure to lose weight.
Insertion and removal of the ReShape Dual Balloon should only be performed by physicians experienced in
diagnostic and therapeutic endoscopy procedures.
Each patient must be monitored closely during the entire term of treatment in order to detect the
development of possible complications. Each patient should be instructed regarding signs and symptoms of
balloon deflation, gastrointestinal obstruction, ulceration and other complications which might occur, and
should be advised to contact his/her physician immediately upon the onset of such signs and symptoms.
It is recommended that patients with a history of documented peptic ulcer associated with H. pylori be tested
for H. pylori and, if found to have a positive test, be treated in accordance with the standard of care prior to
dual balloon insertion.
Ensure that the patient has followed the recommended pre-procedure diet instructions so that no food or
liquid is present in the stomach at the time of the insertion or removal procedure:
o 48 hours prior to the procedure: Soft food only, no meat in any form
o 24 hours prior to the procedure: Clear liquids only
o 12 hours prior to the procedure: No food or liquids by mouth
If food or liquid is present in the stomach at the time of the procedure, it is recommended that the procedure
be delayed until a later time. If this is not possible, endotracheal intubation of the patient is recommended to
reduce the risk of aspiration.
Keep the endoscope tip at least 2-3 cm proximal to the delivery catheter detent while disengaging the
balloon and removing the catheter. The combined diameter of the catheter detent and the endoscope side-
by-side may cause esophageal injury.
In the event of an emergency removal by a physician untrained in the procedure, endotracheal intubation of
the patient is recommended to reduce the risk of aspiration.
During removal, a laryngoscope and Magill forceps should be available in the event the balloon slips off of
the snare and must be retrieved with forceps.
The confirmation of ulcer healing in patients with ulcers at the time of device removal was not evaluated
endoscopically during the REDUCE Pivotal Trial.
Subjects who are found at retrieval endoscopy to have a gastric ulcer should be placed on 6 – 8 weeks of
therapeutic proton pump inhibitor (PPI) medication and followed closely. After completing 6 – 8 weeks of PPI
treatment, subjects experiencing potential ulcer symptoms or signs such as abdominal pain or discomfort,
dyspepsia, anemia or dark stools should be considered for endoscopic examination to assess ulcer
resolution.
The ReShape Dual Balloon is composed of soft silicone elastomer and is easily damaged by instruments or
sharp objects. The balloon must be handled only with gloved hands and with the instruments recommended
in the Instructions for Use.
It is important to discuss all possible complications and adverse events with the patient. Complications that may
result from use of this product include those associated with general endoscopy procedures, those associated with
the ReShape Dual Balloon specifically and those associated with the patient’s degree of intolerance to an implanted
foreign body.
Potential risks associated with an endoscopic procedure and sedation include adverse reaction to sedation
(headache, muscle pain, nausea), anaphylaxis, cardiac arrest, death, hypoxia, myocardial infarction, perforation,
infection, pneumonia, and respiratory distress.
Potential risks associated with the ReShape Dual Balloon include ulceration, perforation, significant gastric bleeding,
need for blood transfusions, emergency endoscopic therapeutic intervention, abdominal pain, abdominal spasms,
nausea, vomiting, bloating, belching, heartburn, dysphagia, dehydration, and sore throat. These complications may
be severe enough to require early removal of the ReShape Dual Balloon. Although the ReShape Dual Balloon
design provides an anti-migration feature, there is the potential risk of device migration and intestinal obstruction.
The risk of intestinal obstruction is increased if the device is not removed after 6 months. If intestinal migration
occurs, the device may pass through the intestine and be passed with stool. However, surgical or endoscopic
removal may be required. Death due to intestinal obstruction is possible and has been reported with other
intragastric balloons.
Additional risks associated with the ReShape Dual Balloon include adverse events related to weight loss and balloon
deflation with subsequent early removal. A potential outcome of use of the ReShape Dual Balloon is insufficient or no
weight loss.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
DEVICE DESCRIPTION
The ReShape™ Integrated Dual Balloon System is a temporary implant designed to facilitate weight loss by occupying space in the stomach. The implant consists of two independently inflated, non-communicating, silicone balloons tethered to a central silicone shaft. It is inserted transorally down the esophagus into the stomach, with endoscopic guidance via a delivery catheter. When inflated, the ReShape Integrated Dual Balloon is designed to occupy a significant portion of the stomach while conforming to the natural shape of the patient’s anatomy.
The device’s flexible dual balloon design is intended to improve patient comfort while reducing the risk of device migration into the intestine. The maximum placement period for the ReShape Dual Balloon is 6 months, and it must be removed at that time or earlier.
At the conclusion of treatment, the ReShape Dual Balloon is aspirated using the ReShape Removal Catheter and removed endoscopically.
Figure 1. ReShape Dual Balloon in the Stomach
Prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal
adhesions.
Prior open or laparoscopic bariatric surgery.
Any inflammatory disease of the gastrointestinal tract including esophagitis, gastric ulceration, duodenal
ulceration, cancer or specific inflammation such as Crohn’s disease.
Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or
acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias
or stenoses.
A gastric mass.
A hiatal hernia > 5 cm or ≤ 5 cm with associated severe or intractable gastro-esophageal reflux symptoms.
A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede
passage of the delivery catheter and/or an endoscope.
Achalasia or any other severe esophageal motility disorder that may pose a safety risk during the removal of
the device
Severe coagulopathy
Hepatic insufficiency or cirrhosis
Serious or uncontrolled psychiatric illness or disorder that could compromise patient understanding of or
compliance with follow up visits and removal of the device after 6 months.
Alcoholism or drug addiction.
Patients unwilling to participate in an established medically-supervised diet and behavior modification
program, with routine medical follow-up.
Patients receiving daily prescribed treatment with aspirin, anti-inflammatory agents, anticoagulants or other
gastric irritants.
Patients who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of
the device implant.
Patients who are known to have, or suspected to have, an allergic reaction to materials contained in the
system.
Patients who have ever developed a serotonin syndrome and are currently taking any drug known to affect
the levels of serotonin in the body [e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin-
norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs)] should not undergo
placement of the device.
Patients who are pregnant or breast-feeding.
WARNINGS
Intestinal obstructions have been reported due to deflated balloons passing into the intestines and have
required surgical removal. Death due to intestinal obstruction is possible and has been reported with other
intragastric balloons. Patients experiencing any symptoms of an intestinal obstruction (e.g., acute onset of
abdominal pain, nausea or vomiting) should be counseled to seek immediate care.
The maximum placement period for the ReShape Dual Balloon is 6 months. The risk of intragastric balloon
deflation and intestinal obstruction (and therefore possible complications related to intestinal obstruction) is
significantly higher when balloons are left in place longer than 6 months.
Patients with known abdominal adhesions or who have had prior abdominal surgery or have any signs or
symptoms of a bowel obstruction should be carefully evaluated prior to use of the ReShape Dual Balloon in
relation to possible intestinal obstruction should the device deflate or pass into the intestines. The risk of
intestinal obstruction may be higher in patients who have had prior abdominal surgery.
The ReShape™ Valve Sealant is necessary to seal the device valves and prevent balloon leakage. Failure
to use the specified amount of Valve Sealant will result in balloon leakage and deflation, and increase the
risk of intestinal obstruction (and therefore possible complications related to intestinal obstruction).
The presence of blue-green urine or sudden loss of satiety, increased hunger and/or weight gain may be a
sign of balloon deflation. Patients should be instructed to immediately contact their physician if they observe
any of these signs. Clinical means of assessing possible deflation include abdominal ultrasound, barium
swallow and endoscopy.
Patients may not observe or report the presence of blue-green urine following a balloon deflation. Patients
should be counseled to seek immediate care if any symptoms of an intestinal obstruction such as acute
abdominal pain, nausea or vomiting develop.
Partially (i.e., one balloon) or fully (i.e., both balloons) deflated devices must be removed promptly. The risk
of intestinal obstruction (and therefore possible complications related to intestinal obstruction) is significantly
higher when deflated devices are not removed promptly.
Failure of patients to take prescribed daily proton-pump inhibitor medication increases the risk of gastric
ulceration or perforation.
Using direct endoscopic visualization, confirm proper positioning of the uninflated balloons in the stomach
prior to inflation. Failure to do so may cause injury to the esophagus, pylorus or duodenum.
Patients receiving serotonergic drugs including SSRIs, SNRIs, MAOIs and other prescription and over-the-
counter drugs should be cautioned about the possibility of developing serotonin syndrome because of the
combination of these medications and the release of methylene blue (in the event of balloon rupture).
Patients should immediately seek medical attention if they develop any symptoms of confusion, headache,
nausea and vomiting, rapid heart rate, or severe sweating. Serotonin syndrome has been reported in
patients given serotonergic psychiatric medications and methylene blue via intravenous administration of
methylene blue at doses ranging from 1 mg/kg to 8 mg/kg.
In the event of balloon rupture, methylene blue would be released into the stomach and absorbed into the
circulation. Methylene blue is a drug with multiple pharmacological indications. Methylene blue is a DNA
binding agent that tests positive for mutagenicity and DNA damage in bacteria, yeast, mammalian cells, and
human tissue obtained after clinical exposures. The internal release of methylene blue would result in a local
concentration that is higher than that delivered by the usual IV injection route. The consequences of
transient acute methylene blue exposure following balloon rupture are not known.
Patients should immediately notify their doctor if they become pregnant while the device is in place, as there
is a risk for release of methylene blue and birth defects (in the event of balloon rupture). An association
exists between the use of methylene blue in amniocentesis and birth defects.
PRECAUTIONS
It is the responsibility of the physician to advise the patient of known risks and complications associated with
the procedure and the device.
It is the responsibility of the physician to advise the patient of the potential need to remove the device in less
than 6 months due to balloon deflation or GI intolerance.
It is the responsibility of the physician to advise the patient that the maximum placement period for the
ReShape Dual Balloon is 6 months and it must be removed at that time or earlier.
Patients must be counseled on the need for proper dietary and exercise habits. Failure to adhere to
prescribed dietary and exercise instructions may result in failure to lose weight.
Insertion and removal of the ReShape Dual Balloon should only be performed by physicians experienced in
diagnostic and therapeutic endoscopy procedures.
Each patient must be monitored closely during the entire term of treatment in order to detect the
development of possible complications. Each patient should be instructed regarding signs and symptoms of
balloon deflation, gastrointestinal obstruction, ulceration and other complications which might occur, and
should be advised to contact his/her physician immediately upon the onset of such signs and symptoms.
It is recommended that patients with a history of documented peptic ulcer associated with H. pylori be tested
for H. pylori and, if found to have a positive test, be treated in accordance with the standard of care prior to
dual balloon insertion.
Ensure that the patient has followed the recommended pre-procedure diet instructions so that no food or
liquid is present in the stomach at the time of the insertion or removal procedure:
o 48 hours prior to the procedure: Soft food only, no meat in any form
o 24 hours prior to the procedure: Clear liquids only
o 12 hours prior to the procedure: No food or liquids by mouth
If food or liquid is present in the stomach at the time of the procedure, it is recommended that the procedure
be delayed until a later time. If this is not possible, endotracheal intubation of the patient is recommended to
reduce the risk of aspiration.
Keep the endoscope tip at least 2-3 cm proximal to the delivery catheter detent while disengaging the
balloon and removing the catheter. The combined diameter of the catheter detent and the endoscope side-
by-side may cause esophageal injury.
In the event of an emergency removal by a physician untrained in the procedure, endotracheal intubation of
the patient is recommended to reduce the risk of aspiration.
During removal, a laryngoscope and Magill forceps should be available in the event the balloon slips off of
the snare and must be retrieved with forceps.
The confirmation of ulcer healing in patients with ulcers at the time of device removal was not evaluated
endoscopically during the REDUCE Pivotal Trial.
Subjects who are found at retrieval endoscopy to have a gastric ulcer should be placed on 6 – 8 weeks of
therapeutic proton pump inhibitor (PPI) medication and followed closely. After completing 6 – 8 weeks of PPI
treatment, subjects experiencing potential ulcer symptoms or signs such as abdominal pain or discomfort,
dyspepsia, anemia or dark stools should be considered for endoscopic examination to assess ulcer
resolution.
The ReShape Dual Balloon is composed of soft silicone elastomer and is easily damaged by instruments or
sharp objects. The balloon must be handled only with gloved hands and with the instruments recommended
in the Instructions for Use.
It is important to discuss all possible complications and adverse events with the patient. Complications that may
result from use of this product include those associated with general endoscopy procedures, those associated with
the ReShape Dual Balloon specifically and those associated with the patient’s degree of intolerance to an implanted
foreign body.
Potential risks associated with an endoscopic procedure and sedation include adverse reaction to sedation
(headache, muscle pain, nausea), anaphylaxis, cardiac arrest, death, hypoxia, myocardial infarction, perforation,
infection, pneumonia, and respiratory distress.
Potential risks associated with the ReShape Dual Balloon include ulceration, perforation, significant gastric bleeding,
need for blood transfusions, emergency endoscopic therapeutic intervention, abdominal pain, abdominal spasms,
nausea, vomiting, bloating, belching, heartburn, dysphagia, dehydration, and sore throat. These complications may
be severe enough to require early removal of the ReShape Dual Balloon. Although the ReShape Dual Balloon
design provides an anti-migration feature, there is the potential risk of device migration and intestinal obstruction.
The risk of intestinal obstruction is increased if the device is not removed after 6 months. If intestinal migration
occurs, the device may pass through the intestine and be passed with stool. However, surgical or endoscopic
removal may be required. Death due to intestinal obstruction is possible and has been reported with other
intragastric balloons.
Additional risks associated with the ReShape Dual Balloon include adverse events related to weight loss and balloon
deflation with subsequent early removal. A potential outcome of use of the ReShape Dual Balloon is insufficient or no
weight loss.
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