Déclaration succincte

United States

Caution: Federal law restricts this device to sale by or on the order of a physician.

Indication: The Pulmonx Zephyr^® Endobronchial Valves are implantable bronchial valves indicated for the bronchoscopic treatment of adult patients with hyperinflation associated with severe emphysema in regions of the lung that have little to no collateral ventilation.

Contraindication: La valve Zephyr est contre-indiquée dans les cas suivants : les patients pour lesquels les procédures bronchoscopiques sont contre-indiquées ; les patients présentant des signes d’infection pulmonaire active ; les patients présentant des allergies connues au nitinol (nickel-titane) ou aux métaux dont il se compose (nickel ou titane) ; les patients présentant des allergies connues au silicone ; les patients qui n’ont pas arrêté de fumer ; les patients présentant des bulles volumineuses couvrant plus de 30 % d’un poumon quel qu’il soit.

Warnings: The Zephyr Valve should be used with caution and only after careful consideration in patients with: Prior lung transplant, LVRS, median sternotomy, or lobectomy; Congestive heart failure or recent myocardial infarction; FEV₁ <15% of predicted value. The Zephyr EDC handle contains strong permanent magnets. To avoid interference and possible patient/clinician harm, keep it more than 2 inches away from medical devices that could be affected by the magnetic fields.

General Precautions: Read all labels and instructions prior to use. Use is restricted to a physician trained in the use of this device. The Zephyr Valve and EDC are intended for single-patient use only. Do not re-sterilize. No assurance of sterility can be made if devices are re-used. Do not attempt to reload a Zephyr Valve. Do not use the device if the sterilization barrier has been damaged or if the device is dropped after removal from sterile packaging. Performance of the Zephyr Valve has not been assessed in physiological conditions unique to air leak patients with an open thoracic window (also known as a Claggett Window or Eloesser Flap). The Zephyr Valve device may be subject to fracture due to unusual physical forces in this setting. Safety in uncontrolled pulmonary hypertension has not been evaluated. The Zephyr Valve was evaluated in patients with heterogenous emphysema in the pivotal trial, LIBERATE Study. Limited data on the use of this device in homogeneous emphysema patients come from the OUS IMPACT trial.

Adverse Effects: Probable adverse events include, but are not limited to, the following: Acute respiratory distress syndrome; Airway erosion; Airway stenosis; Aphonia; Bowel function impairment; Bronchitis; Bronchospasm; Chest Pain; COPD exacerbation; Cough; Death; Disorientation/anxiety; Dyspnea; Empyema; Epistaxis; Fever; Granulation tissue / ulceration formation; Headache; Heart arrhythmia; Heart Failure; Hematoma; Hemoptysis; Hemothorax; Hypotension; Hypercapnia; Hypoxemia; Iatrogenic injuries; Impaired lung function; Increased mucus secretions; Infection; Insomnia; Musculoskeletal event; Myocardial infarction; Nausea/vomiting; Pain; Pleural effusion; Pneumonia; Pneumothorax; Pulmonary embolism; Pulmonary shunting; Residual volume increase; Respiratory failure; Sepsis; Shortness of breath; Sore throat; Stroke/CVA/TIA; Systemic inflammatory response syndrome (SIRS); Valve migration/expectoration; Vocal cord injury; Wheeze or whistling.

Prior to use, please reference the Zephyr EBV System Instructions for more information on indications, contraindications, warnings, all precautions, and adverse events.

Brief Statement: The Pulmonx Zephyr^® Endobronchial Valves are implantable bronchial valves indicated for the bronchoscopic treatment of adult patients with hyperinflation associated with severe emphysema in regions of the lung that have little to no collateral ventilation. La valve Zephyr est contre-indiquée dans les cas suivants : les patients pour lesquels les procédures bronchoscopiques sont contre-indiquées ; les patients présentant des signes d’infection pulmonaire active ; les patients présentant des allergies connues au nitinol (nickel-titane) ou aux métaux dont il se compose (nickel ou titane) ; les patients présentant des allergies connues au silicone ; les patients qui n’ont pas arrêté de fumer ; les patients présentant des bulles volumineuses couvrant plus de 30 % d’un poumon quel qu’il soit. Ce dispositif doit être utilisé exclusivement par un médecin ayant suivi une formation. Avant l’utilisation, veuillez consulter le mode d’emploi du système de valve endobronchique Zephyr, où vous trouverez des informations supplémentaires concernant les indications, les contre-indications, les mises en garde, toutes les précautions à prendre et les événements indésirables.

Brief Statement: The Chartis^® System is indicated for use by bronchoscopists during a bronchoscopy in adult patients with emphysema, a form of Chronic Obstructive Pulmonary Disease (COPD), in a bronchoscopy suite. The system, composed of the Chartis Catheter and Chartis Console, is designed to measure pressure and flow in order to calculate resistance to airflow and quantify collateral ventilation in isolated lung compartments. The Chartis Catheter is used through the working channel of a bronchoscope and connects to the Chartis Console. The Chartis Console is capital equipment that is reusable and displays the patient information.

The Chartis System is contraindicated in the presence of active infection or major bleeding diathesis. There are no known interfering substances. Ce dispositif doit être utilisé exclusivement par un médecin ayant suivi une formation. Prior to use, please reference the Chartis System Instructions for Use/ User Manual for more information on indications, contraindications, warnings, all precautions, and adverse events.