SSCP Medical Device Summary

RITA™ Intragastric Balloon System

Structured Summary of Safety and Clinical Performance content, arranged for clear reading, regulatory scanability, and a professional WordPress page layout.

ManufacturerSacredLotus s.r.o.

SRNCZ-MF-000041155

Basic UDI-DI859422251RITALS

Maximum Placement6 months

Manufacturer and device traceability

Device and Manufacturer Identification

SacredLotus s.r.o.
CZECH REPUBLIC, PRAGUE, NA HŘEBENKÁCH 815/130
SRN: CZ-MF-000041155
Basic UDI-DI: 859422251RITALS
UDI-DI: 8594222510017

Clinical use profile

Intended Purpose, Indications, Contraindications and Target Population

INTENDED PURPOSE

RITA™ Intragastric Balloon System is indicated for temporary use in weight- loss therapy for obese adult patients (18 years of age or older) who have significant health risks related to their obesity and who have failed to achieve and maintain weight loss with а supervised weight control program.

INTENDED PATIENT POPULATION

Patient population: adult patients (18 years of age or older) who have significant health risks related to their obesity.
RITA™ Intragastric Balloon System is intended for use with adult patients in clinical settings.

INTENDED USERS

Intended operator: Healthcare professionals.
Intended users: Ambulatory patients (prescription only).

Indications

RITA™ Intragastric Balloon System is indicated for temporary use in weight- loss therapy for obese adult patients (18 years of age or older) who have significant health risks related to their obesity and who have failed to achieve and maintain weight loss with a supervised weight-control program (see specific indications below).
Pre-surgical temporary use for weight loss in obese patients (BMI 40 and above or а BMI of 35 or above with comorbidities) prior to obesity or other surgery, in order to reduce surgical risk.
Temporary use for weight loss in obese patients (BMI 30-39) who have significant health risks related to their obesity and who have failed to achieve and maintain weight loss with а supervised weight-control program. RITA™ Intragastric Balloon System is to be used in conjunction with а long- term supervised diet and behaviour modification program designed to increase the possibility of long-term weight- loss maintenance.
Temporary use for weight loss in obese patients (BMI 40 or above, or BMI 35 or above with comorbidities) who are not candidates for obesity surgery, in conjunction with а long-term supervised diet and behaviour modification program designed to increase the possibility of long-term weight-loss maintenance.
The maximum placement period for RITA™ Intragastric Balloon System is 6 months, and it must be removed at that time or earlier.

Contraindications

The presence of more than one IGB at the same time.
Use of the IGB is contraindicated for weight loss for cosmetic reasons only.
Use of the IGB System is contraindicated for weight loss in patients with а BMI less than 30, unless accompanied by comorbidities associated with obesity that would be expected to improve with weight loss.
Prior surgery involving the oesophagus, stomach, and duodenum or 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 oesophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresia or stenoses.
А large hiatal hernia of > 5cm or а hernia 5 cm associated with severe or intractable gastro oesophageal reflux symptoms.
А structural abnormality in the oesophagus or pharynx such as а stricture or diverticulum that could impede passage of the delivery catheter and/ or an endoscope.
Achalasia, symptoms suggestive of delayed gastric emptying, or presence of any other severe motility disorder that that may pose а safety risk during placement or removal of the device.
Gastric Mass.
Severe coagulopathy.
Hepatic insufficiency or cirrhosis involving:
Acute liver failure and advanced cirrhosis with encephalopathy muscle wasting and anasarca.
Large oesophageal varices with red colour signs and gastric varices.
Severe portal hypertensive gastropathy with or without gastric antral vascular ectasia.
Patients who are known to have or suspected to have an allergic reaction to materials contained in the IGB.
Any other medical condition that would not permit elective endoscopy such as poor general health or history and/or symptoms of severe renal, hepatic, cardiac, and/or pulmonary disease.
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 who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant.
Patients unwilling to participate in an established medically supervised diet and behaviour modification program, with routine medical follow-up.
Patients receiving aspirin, anti-inflammatory agents, anticoagulants, or other gastric irritants, not under medical supervision.
Patients who are known to be pregnant or breast feeding.

System overview

Device Description and Components

GENERAL DESCRIPTION OF THE MEDICAL DEVICE

The RITA™ Intragastric Balloon System is a single-use, non-sterile, silicone intragastric balloon intended for temporary endoscopic implantation in the stomach to assist weight reduction in adults when used as part of a comprehensive weight management programme.

Following endoscopic placement, the balloon is filled with sterile saline to a volume selected by the physician within the recommended filling range of 400–700 ml (сс). The inflated balloon occupies space within the stomach, promoting early satiety and reduced food intake during the intended implantation period of up to six months. After filling, the placement catheter is detached through a self-sealing valve, allowing the balloon to remain freely floating within the stomach until scheduled removal.

DEVICE COMPONENTS

The completed Patient Implant Card is provided to the patient after implantation and contains device identification information, physician contact details and the recommended balloon removal date.

The RITA™ Intragastric Balloon System includes:
RITA™ silicone intragastric balloon with integrated self-sealing valve;
Placement catheter with depth markings;
Filling kit, consisting of a filling tube, filling connector/spike and clamp;
Instructions for Use (IFU);
Patient Implant Card.

PREVIOUS GENERATIONS, VARIANTS AND ACCESSORIES

The device is intended to be used in combination with standard endoscopic equipment and sterile saline for balloon filling, as specified in the Instructions for Use.

The RITA™ Intragastric Balloon System has no previous generations or variants covered by this SSCP.

Treatment context

Diagnostic or Therapeutic Alternatives

Overview

Possible therapeutic alternatives include:

The choice of treatment should be based on an individual clinical assessment, taking into account the patient's body mass index (BMI), obesity-related comorbidities, previous weight management attempts, treatment goals, patient preferences and the treating physician's clinical judgement.

lifestyle intervention alone, including dietary modification, increased physical activity and behavioural therapy;
pharmacological treatment for obesity, where clinically indicated and prescribed in accordance with applicable clinical guidelines;
endoscopic bariatric therapies, where appropriate;
bariatric surgery (e.g. sleeve gastrectomy or gastric bypass) for patients meeting the relevant clinical criteria.

Standards reference

Harmonised Standards and Common Specifications Applied

No harmonised standards or common specifications are listed in the provided document.

Evidence summary

Clinical Evaluation and PMCF Summary

Overview

Clinical evaluation was performed in accordance with Annex XIV of Regulation (EU) 2017/745 and was based primarily on clinical investigation data generated for the RITA™ Intragastric Balloon System, supported by a systematic review of the relevant scientific literature, including published evidence on comparable intragastric balloon technologies. The overall clinical evidence demonstrates that the device achieves its intended clinical performance with an acceptable safety profile and a favorable benefit-risk ratio for the intended patient population and maximum implantation period of six months.

Professional requirements

User Profile and Training

Overview

The device is intended for use only by physicians qualified and experienced in diagnostic and therapeutic upper gastrointestinal endoscopy and trained in the placement and removal of intragastric balloon systems. Before first clinical use, users should complete manufacturer-provided training covering device preparation, implantation, filling, positioning, patient management, removal procedures, recognition and management of potential adverse events, and the Instructions for Use (IFU).

The device should be used within a multidisciplinary weight management programme that includes appropriate patient selection, nutritional counselling, behavioural and lifestyle support, clinical follow-up, and access to endoscopic, anaesthetic and emergency medical services, as appropriate. Healthcare personnel involved in device preparation and patient care should receive appropriate training in accordance with the manufacturer's Instructions for Use and the healthcare institution's procedures.

Safety information

Residual Risks, Warnings and Precautions

WARNINGS

Proper positioning of the Placement Catheter Assembly and the IGB within the stomach (using measured distance from the incisors via the insertion tube markings) is necessary to allow proper filling. Lodging of the IGB in the oesophageal opening during filling may cause serious injury. Failure to confirm proper positioning may cause injury to the oesophagus, duodenum, or pylorus.
When filling the IGB during the placement procedure, avoid rapid fill rates as these will generate high pressure which can damage the IGB valve or cause premature detachment of the IGB from the tip of the placement catheter.
Each patient must be monitored closely during the entire term of treatment in order to detect the development of possible adverse events. Each patient should be instructed regarding symptoms of deflation, gastrointestinal obstruction, acute pancreatitis, IGB inflation after placement (i.e., spontaneous hyperinflation), ulceration, gastric and oesophageal perforation, and other adverse events which might occur, and should be advised to contact his/her physician immediately upon the onset of such symptoms. Patients need to be evaluated and the device removed at or within 6 months of placement.
Patients must be advised that the IGB is intended to be placed for 6 months maximally, at which point removal is required. Longer periods of IGB placement increase the risk of IGB deflation (а reduction in size of the device due to loss of saline) which can lead to intestinal obstruction and risk for death. The risk of these events is also significantly higher when filled to а larger volume than indicated (greater than 700сс).
Bowel obstructions have been reported due to deflated IGBs (i.e., collapsed) passing into the intestines and have required surgical removal. The risk of intestinal obstruction may be higher in patients who have а dysmotility disorder or who have had prior abdominal or gynaecological surgery, radiation therapy, and/or active inflammatory bowel disease, so this should be considered in assessing the risk of the procedure. Bowel obstructions can result in death.
Deflated devices should be removed promptly. Patients should be advised that IGB deflation may lead to serious adverse events including bowel obstruction and need for emergency surgery. Patients should immediately call their physician to receive instructions on preparing for removal of the IGB.
Patients reporting loss of satiety, increased hunger and/or weight gain should be examined endoscopically, as this is indicative of а IGB deflation.
If it is necessary to replace an IGB that has spontaneously deflated (i.e., collapsed), fill the replacement IGB with the same volume of sterile saline that was used during the placement of previous IGB (i.e., initial fill volume). А greater initial fill volume in the replacement IGB may result in severe nausea, vomiting or ulcer formation.
Acute pancreatitis has been reported as а result of injury to the pancreas by the IGB. Patients experiencing any symptoms of acute pancreatitis should be counselled to seek immediate care. Symptoms may include nausea, vomiting, abdominal or back pain, either steady or cyclic. If abdominal pain is steady, pancreatitis may have developed.
Spontaneous hyperinflation of an indwelling IGB with gas has been reported in patients with an indwelling 1GB. Symptoms of significant 1GB overinflation include intense abdominal pain, swelling of the upper abdomen (abdominal distension) with or without discomfort, difficulty breathing, gastroesophageal reflux, nausea and/or vomiting. Patients experiencing any of these symptoms should be counselled to seek immediate care and should be evaluated for hyperinflation, particularly when persistent abdominal pain, abdominal distension, and food intolerance occur beyond the initial accommodative period of the IGB. Plain radiographic films will often demonstrate hyperinflation with а large air-fluid level within the IGB and an increase in IGB volume compared to the original volume.
Hyperinflation of the IGB often warrants its early removal to prevent serious complications such as gastric outlet obstruction and contact ulceration. Because hyperinflation increases the internal pressure of the IGB (due to accumulated gas) and may increase the fragility of the IGB wall, there is an increased risk of rupture followed by the sudden forceful release of gas and fluid contents when it is punctured or endoscopically manipulated. Therefore, it is suggested that the patient's airway is protected with endotracheal intubation prior to endoscopic removal in order to prevent pulmonary aspiration of the balloon contents. Additionally, in situations in which controlled balloon aspiration is done, it is recommended that mid-stream fluid aspirated from the balloon is sent for bacterial and fungal cultures.
Pregnancy or breast-feeding contraindicates use of this device. Should pregnancy be confirmed at any time during the course of treatment, the device should be removed as soon as it is safely possible.
Endoscopic removal of the IGB must be completed in the presence of an empty stomach. Patients should be on а liquid diet for 72 hours and NPO (i.e., nothing by mouth) for а minimum of 12 hours prior to removal. If food is found in the stomach upon endoscopic examination, then measures (aspiration of stomach contents, endotracheal intubation, or delay of procedure) must be taken to protect the airway. The risk of aspiration of gastric contents into the patient's lungs represents а serious risk which can result in death. IGBs cause delayed gastric emptying which may increase the time typically needed to ensure an empty stomach prior to endoscopic procedures.
Patients should be advised to take the necessary precautions to prevent pregnancy prior to placement and throughout the duration of treatment. Patients should be instructed to inform you as soon as possible if pregnancy is confirmed during treatment, so that removal of the device can be arranged.
Patients with an IGB that present with severe abdominal pain that have а negative endoscopy and x-ray may additionally require а СТ scan to definitively rule out а perforation.
The IGB is composed of soft silicone elastomer and is easily damaged by instruments or sharp objects. The IGB must be handled only with gloved hands and with the instruments recommended in the IFU.

PRECAUTIONS

Temporary weight-loss treatments have been shown to have poor long-term success rates in obese and severely obese patients.
When filling the IGB, the use of sterile saline and aseptic technique, similar to changing IV fluids (e.g., use of clean gloves, sterile syringe, etc.), is recommended. Though the cause of hyperinflation is unknown, it may be caused by fungal or bacterial microbes contaminating the balloon. One recommended mitigation is to avoid contaminating the saline within the balloon with micro-organisms that may lead to spontaneous hyperinflation.
If difficulty with the IGB Placement Catheter Assembly is noted during placement (e.g., resistance to IGB filling), then the device should be removed and replaced with а new IGB. To lessen, or prevent Placement Catheter defects, the catheter must remain slack during the filling process. If the Placement Catheter is under tension during this process, the tip of the catheter may dislodge from the IGB and prevent further IGB deployment.
Placement of the IGB within the stomach has been shown to produce а delay in gastric emptying. This can create а variety of expected and predictable reactions including а feeling of heaviness in the abdomen, nausea and vomiting, gastroesophageal reflux, belching, esophagitis, heartburn, diarrhoea and, at times, abdominal, back, or epigastric pain and cramping. Food digestion may be slowed throughout the entire placement duration due to the delay in gastric emptying. Most patients acclimate to the presence of the device within the first two (2) weeks. ln order to prevent or ameliorate the symptoms most frequently experienced after placement, physicians should prescribe proton pump inhibitors (PPls) and antiemetics prophylactically and consider prescribing temporarily antispasmodics or anticholinergic medications for cramping due to accommodation of the IGB, and/or prokinetic medications for symptoms due to the delay in gastric emptying. Patients should be advised to immediately contact their physician for any unusually severe, worsening, or recurrent symptoms as these medications can further delay gastric emptying and may lead to stomach distention, perforation and possibly death.
To prevent ulcers and control gastroesophageal reflux symptoms, it is recommended that the patient start а program of oral proton pump inhibitors (PPls) for approximately 3-5 days prior to IGB placement so а maximal gastric acid suppression effect will be present on the day of placement. It is recommended that the PPI dose be given sublingually after IGB placement if nausea and/or vomiting are present. А starting full dose daily regimen of an oral PPI should be continued as long as the IGB is in place.
Other medications that are started prophylactically should be continued after IGB placement until they are no longer needed. Furthermore, subjects will be directed to avoid medications known to cause or exacerbate gastroduodenal mucosal damage.
The IGB is а silicone elastomer balloon which may be degraded by gastric acid. Physicians have reported the concurrent use of medications, such as proton pump inhibitors, may reduce acid formation or reduce acidity which can prolong the integrity of the IGB (reduce the risk of device deflation) and may help to reduce the risk of gastric ulcers and subsequent perforation.
The physiological response of the patient to the presence of the IGB may vary depending upon the patient's general condition and the level and type of activity. The types and frequency of administration of drugs or diet supplements and the overall diet of the patient may also affect the response.
The IGB has not been studied on individuals who have а patulous pylorus, active Н. pylori infection, and subjects with either symptoms or а diagnosis of delayed gastric emptying.
Patients taking anti-cholinergic medications or psychotropic medications should be informed that these medications will delay gastric emptying and should be used sparingly as they may put them at greater risk for stomach distention and perforation. Patients should be advised to immediately contact their physician for any unusually severe, worsening, or recurrent symptoms.
А patient who's deflated (i.e., collapsed) IGB has moved into the intestines must be monitored closely for an appropriate period of time (at least 2 weeks) to confirm its uneventful passage through the intestine.
ln preparation for removal, some patients may have retained contents in the stomach. Some patients may have clinically significant delay in gastric emptying and refractory intolerance to the IGB, necessitating early removal, and possibly leading to other adverse events. These patients may be at higher risk of aspiration upon removal and/or upon administration of anaesthetic. The anaesthesia team should be alerted to the risk for aspiration in these patients.

RISK ASSOCIATED WITH RE-USE

The IGB System is for single use only. Removal of the IGB requires that it be punctured in situ to deflate, and any subsequent reuse would result in the IGB deflating in the stomach. This could lead to possible bowel obstruction and may require surgery to remove. Should an IGB be removed from the patient prior to being filled with saline, it still cannot be reused on а new patient as any attempt to decontaminate this device could cause damage resulting again in deflation after implantation.

Possible Adverse Events

Possible adverse events associated with the use of the IGB include:
Death due to complications related to aspiration, intestinal obstruction, gastric perforation, or oesophageal perforation, is possible.
Intestinal obstruction by the IGB. An insufficiently filled IGB or a leaking IGB that has lost sufficient volume may be able to pass from the stomach into the small bowel. It may pass all the way into the colon and be passed with stool. However, if there is a narrow area in the bowel or adhesion formation, which may occur after previous surgery on the bowel, the IGB may not pass and could cause a bowel obstruction. If this occurs, surgery or endoscopic removal could be required.
Oesophageal obstruction. When the IGB is being filled in the stomach, the IGB could be inadvertently pulled back into the oesophagus. This can cause rupture of the oesophagus. If this occurs, surgery or endoscopic removal could be required.
Gastric outlet obstruction. A partially filled IGB (i.e., <400cc), or a leaking IGB could lead to gastric outlet obstruction, requiring IGB removal. It is also possible for a fully filled (400-700cc) IGB to impair the gastric outlet, which can produce a mechanical impediment to gastric emptying. Gastric outlet obstruction may require early removal.
Gastric distention with retained food and fluid due to severely delayed gastric emptying with or without outlet obstruction from displacement of the IGB into the antrum.
Injury to the digestive tract during placement of the IGB in an improper location such as in the oesophagus or duodenum. This could cause bleeding and perforation, which could require a surgical or endoscopic correction for control.
Insufficient or no weight loss.
Adverse health consequences resulting from weight loss.
Gastric discomfort, feelings of nausea and vomiting following IGB placement as the digestive system adjusts to the presence of the IGB.
Continuing nausea and vomiting. This could result from direct irritation of the lining of the stomach, delayed gastric emptying and/or the IGB blocking the outlet of the stomach. It is even theoretically possible that the IGB could prevent vomiting (not nausea or retching) by blocking the inlet to the stomach from the oesophagus.
A feeling of heaviness in the abdomen.
Abdominal or back pain, either steady or cyclic.
Gastroesophageal reflux.
Influence on digestion of food.
Blockage of food entering into the stomach.
Bacterial growth in the fluid which fills the IGB. Rapid release of this fluid into the intestine could cause infection, fever, cramps, and diarrhoea.
Injury to the lining of the digestive tract as a result of direct contact with the endoscope, the IGB, grasping forceps, or as a result of increased acid production by the stomach. This could lead to ulcer formation with pain, bleeding or even perforation. Surgery could be necessary to correct this condition.
IGB deflation (i.e., collapse) and subsequent replacement.
Acute pancreatitis.
Spontaneous hyperinflation due to gas production within the IGB.

POSSIBLE COMPLICATIONS OF ROUTINE ENDOSCOPY & SEDATION

Potential risks associated with upper endoscopic procedures include but are not limited to abdominal cramping and discomfort if air is used to distend the stomach, sore or irritated throat, bleeding, infection, tearing of the oesophagus or stomach that could lead to perforation, and aspiration pneumonia. The risk increases if additional procedures are performed.
According to the American College of Gastroenterology, risks related to sedation during endoscopic procedures are rare, occurring in less than one in every 10,000 people. The most common complications involve a temporary decrease in the rate of breathing or heart rate, which can be corrected by giving extra oxygen or by reversing the effect of the sedative medications. Patients with heart, lung, kidney, liver, or other chronic diseases are at higher risk for complications. Drug dosages and airway management should be taken into consideration when treating high risk patients.