Edwards SAPIEN XT Transcatheter Heart Valve with the NovaFlex+ Delivery System – Pulmonic
Indications: The Edwards SAPIEN XT transcatheter heart valve (THV) systems are indicated for use in pediatric and adult patients with a dysfunctional, non-compliant right ventricular outflow tract (RVOT) conduit with a clinical indication for intervention and: pulmonary regurgitation ≥ moderate and/or mean RVOT gradient ≥ 35 mmHg.
Contraindications: The THV and delivery systems are contraindicated in patients with inability to tolerate an anticoagulation/antiplatelet regimen or who have active bacterial endocarditis.
Warnings: The devices are designed, intended, and distributed for single use only. Do not resterilize or reuse the devices . There are no data to support the sterility, nonpyrogenicity, and functionality of the devices after reprocessing. Assessment for coronary compression risk prior to valve implantation is essential to prevent the risk of severe patient harm. Incorrect sizing of the THV may lead to paravalvular leak, migration, embolization and/or RVOT rupture. Accelerated deterioration of the THV may occur in patients with an altered calcium metabolism. Prior to delivery, the THV must remain hydrated at all times and cannot be exposed to solutions other than its shipping storage solution and sterile physiologic rinsing solution. THV leaflets mishandled or damaged during any part of the procedure will require replacement of the THV. Do not use the THV if the tamper evident seal is broken, the storage solution does not completely cover the THV, the temperature indicator has been activated, the THV is damaged, or the expiration date has elapsed. Do not mishandle the NovaFlex+ delivery system or use it if the packaging or any components are not sterile, have been opened or are damaged (e.g. kinked or stretched), or the expiration date has elapsed. Use of excessive contrast media may lead to renal failure. Measure the patient’s creatinine level prior to the procedure. Contrast media usage should be monitored. Patient injury could occur if the delivery system is not un-flexed prior to removal. Care should be exercised in patients with hypersensitivities to cobalt, nickel, chromium, molybdenum, titanium, manganese, silicon, and/or polymeric materials. The procedure should be conducted under fluoroscopic guidance. Some fluoroscopically guided procedures are associated with a risk of radiation injury to the skin. These injuries may be painful, disfiguring, and long-lasting. THV recipients should be maintained on anticoagulant/antiplatelet therapy as determined by their physician. This device has not been tested for use without anticoagulation. Do not add or apply antibiotics to the storage solution, rinse solutions, or to the THV.
Precautions: Safety, effectiveness, and durability of the THV have not been established for implantation within a previously placed surgical or transcatheter pulmonic valve. Long-term durability has not been established for the THV. Regular medical follow-up is advised to evaluate THV performance. Glutaraldehyde may cause irritation of the skin, eyes, nose and throat. Avoid prolonged or repeated exposure to, or breathing of, the solution. Use only with adequate ventilation. If skin contact occurs, immediately flush the affected area with water; in the event of contact with eyes, immediately flush the affected area with water and seek immediate medical attention. For more information about glutaraldehyde exposure, refer to the Material Safety Data Sheet available from Edwards Lifesciences. Patient anatomy should be evaluated to prevent the risk of access that would preclude the delivery and deployment of the device. To maintain proper valve leaflet coaptation, do not overinflate the deployment balloon. Appropriate antibiotic prophylaxis is recommended post-procedure in patients at risk for prosthetic valve infection and endocarditis. Safety and effectiveness have not been established for patients with the following characteristics/comorbidities: Echocardiographic evidence of intracardiac mass, thrombus, or vegetation; a known hypersensitivity or contraindication to aspirin, heparin or sensitivity to contrast media, which cannot be adequately premedicated; pregnancy; and patients under the age of 10 years.
Potential Adverse Events: Potential risks associated with the overall procedure including potential access complications associated with standard cardiac catheterization, balloon valvuloplasty, the potential risks of conscious sedation and/or general anesthesia, and the use of angiography: death; respiratory insufficiency or respiratory failure; hemorrhage requiring transfusion or intervention; cardiovascular injury including perforation or dissection of vessels, ventricle, myocardium or valvular structures that may require intervention; pericardial effusion or cardiac tamponade; embolization including air, calcific valve material or thrombus; infection including septicemia and endocarditis; heart failure; myocardial infarction; renal insufficiency or renal failure; conduction system defect arrhythmia; arteriovenous fistula; reoperation or reintervention; ischemia or nerve injury; pulmonary edema; pleural effusion, bleeding; anemia; abnormal lab values (including electrolyte imbalance); hypertension or hypotension; allergic reaction to anesthesia, contrast media, or device materials; hematoma or ecchymosis; syncope; pain or changes at the access site; exercise intolerance or weakness; inflammation; angina; fever. Additional potential risks associated with the use of the THV, delivery system, and/or accessories include: cardiac arrest; cardiogenic shock; emergency cardiac surgery; coronary flow obstruction/transvalvular flow disturbance; device thrombosis requiring intervention; valve thrombosis; device embolization; device malposition requiring intervention; valve deployment in unintended location; structural valve deterioration (wear, fracture, calcification, leaflet tear/tearing from the stent posts, leaflet retraction, suture line disruption of components of a prosthetic valve, thickening, stenosis); paravalvular or transvalvular leak; valve regurgitation; hemolysis; device explants; nonstructural dysfunction; and mechanical failure of delivery system, and/or accessories.
Indications: The Edwards crimper is indicated for use in preparing the Edwards SAPIEN XT transcatheter heart valve for implantation.
Contraindications: No known contraindications.
Warnings: The device is designed, intended, and distributed for single use only. Do not resterilize or reuse the device. There are no data to support the sterility, nonpyrogenicity, and functionality of the device after reprocessing. Do not mishandle the device. Do not use the device if the packaging or any components are not sterile, have been opened or are damaged, or the expiration date has elapsed.
Precautions: For special considerations associated with the use of this device prior to THV implantation, refer to the SAPIEN XT transcatheter heart valve Instructions for Use.
Potential Adverse Events: No known potential adverse events.
CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician.