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Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra, and Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve System

Indications:  The Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve system is indicated to reduce the risks associated with progression from asymptomatic to symptomatic severe native calcific aortic stenosis in patients who are judged by a heart team to be appropriate for transcatheter heart valve replacement therapy.

The Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve system is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a Heart Team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy.

The Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve system is indicated for patients with symptomatic heart disease due to a failing (stenosed, insufficient, or combined) surgical or transcatheter bioprosthetic aortic valve, or a native mitral valve with an annuloplasty ring who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the STS risk calculator).

The Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valvesystem is indicated for patients with symptomatic heart disease due to a failing (stenosed,insufficient, or combined) surgical bioprosthetic mitral valve who are judged by a heart team,including a cardiac surgeon, to be at intermediate or greater risk for open surgical therapy (i.e.,predicted risk of surgical mortality ≥ 4% at 30 days, based on the Society of Thoracic Surgeons (STS)risk score and other clinical co-morbidities unmeasured by the STS risk calculator).

Contraindications:  The valves and delivery systems are contraindicated in patients who cannot tolerate an anticoagulation/antiplatelet regimen or who have active bacterial endocarditis or other active infections, or who have significant annuloplasty ring dehiscence.

Warnings:  Observation of the pacing lead throughout the procedure is essential to avoid the potential risk of pacing lead perforation. There may be an increased risk of stroke in transcatheter aortic valve replacement procedures, as compared to balloon aortic valvuloplasty or other standard treatments in high or greater risk patients. 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. Incorrect sizing of the valve may lead to paravalvular leak, migration, embolization, residual gradient (patient-prosthesis mismatch), and/or annular rupture. Accelerated deterioration of the valve due to calcific degeneration may occur in children, adolescents, or young adults and in patients with an altered calcium metabolism. Prior to delivery, the valve must remain hydrated at all times and cannot be exposed to solutions other than its shipping storage solution and sterile physiologic rinsing solution. Valve leaflets mishandled or damaged during any part of the procedure will require replacement of the valve. Caution should be exercised in implanting a valve in patients with clinically significant coronary artery disease. Patients with pre-existing prostheses should be carefully assessed prior to implantation of the valve to ensure proper valve positioning and deployment. Do not use the valve if the tamper-evident seal is broken or the storage solution does not completely cover the valve (SAPIEN 3 and SAPIEN 3 Ultra only), the temperature indicator has been activated, the valve is damaged, or the expiration date has elapsed. Do not mishandle the 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 if 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. Valve recipients should be maintained on anticoagulant/antiplatelet therapy, except when contraindicated, 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 (SAPIEN 3 and SAPIEN 3 Ultra only), rinse solution, or to the valve. Balloon valvuloplasty should be avoided in the treatment of failing bioprostheses as this may result in embolization of bioprosthesis material and mechanical disruption of the valve leaflets. Do not perform stand-alone balloon aortic valvuloplasty procedures in the INSPIRIS RESILIA aortic valve for the sizes 19-25 mm. This may expand the valve causing aortic incompetence, coronary embolism or annular rupture. Transcatheter valve replacement in mitral annuloplasty rings is not recommended in cases of partial annuloplasty ring dehiscence due to high risk of PVL. Transcatheter valve replacement in mitral annuloplasty rings is not recommended in cases of partial (incomplete) annuloplasty rings in the absence of annular calcium due to increased risk of valve embolization. Transcatheter valve replacement in mitral annuloplasty rings is not recommended in cases of rigid annuloplasty rings due to increased risk of PVL or THV deformation.

Precautions:  Long-term durability has not been established for the valve. Regular medical follow-up is advised to evaluate valve performance. Limited clinical data are available for transcatheter aortic valve replacement in patients with a congenital bicuspid aortic valve who are deemed to be at low surgical risk. Anatomical characteristics should be considered when using the valve in this population. In addition, patient age should be considered as long-term durability of the valve has not been established. 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, seek immediate medical attention. For more information about glutaraldehyde exposure, refer to the Safety Data Sheet available from Edwards Lifesciences. If a significant increase in resistance occurs when advancing the catheter through the vasculature, stop advancement and investigate the cause of resistance before proceeding. Do not force passage, as this could increase the risk of vascular complications. As compared to SAPIEN 3, system advancement force may be higher with the use of SAPIEN 3 Ultra/SAPIEN 3 Ultra RESILIA THV in tortuous/challenging vessel anatomies. 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. Additional precautions for transseptal replacement of a failed mitral valve bioprosthesis include, the presence of devices or thrombus or other abnormalities in the caval vein precluding safe transvenous femoral access for transseptal approach; and the presence of an Atrial Septal Occluder Device or calcium preventing safe transseptal access. Special care must be exercised in mitral valve replacement to avoid entrapment of the subvalvular apparatus. Safety and effectiveness have not been established for patients with the following characteristics/comorbidities: non-calcified aortic annulus; severe ventricular dysfunction with ejection fraction < 20%; congenital unicuspid aortic valve; pre-existing prosthetic ring in the tricuspid position; severe mitral annular calcification (MAC); severe (> 3+) mitral insufficiency, or Gorlin syndrome; blood dyscrasias defined as leukopenia (WBC < 3000 cells/mL), acute anemia (Hb < 9 g/dL), thrombocytopenia (platelet count < 50,000 cells/mL), or history of bleeding diathesis or coagulopathy; hypertrophic cardiomyopathy with or without obstruction (HOCM); echocardiographic evidence of intracardiac mass, thrombus, or vegetation; a known hypersensitivity or contraindication to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel (Plavix), or sensitivity to contrast media, which cannot be adequately premedicated; significant aortic disease, including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5 cm or greater, marked tortuosity (hyperacute bend), aortic arch atheroma (especially if thick [> 5 mm], protruding, or ulcerated) or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe “unfolding” and tortuosity of the thoracic aorta; access characteristics that would preclude safe placement of the Edwards sheath, such as severe obstructive calcification or severe tortuosity; bulky calcified aortic valve leaflets in close proximity to coronary ostia; a concomitant paravalvular leak where the failing prosthesis is not securely fixed in the native annulus or is not structurally intact (e.g., wireform frame fracture, annuloplasty ring dehiscence); or a partially detached leaflet of the failing bioprosthesis that in the aortic position may obstruct a coronary ostium. For Left axillary approach, a left subclavian takeoff angle ~ ≥ 90° from the aortic arch causes sharp angles, which may be responsible for potential sheath kinking, subclavian/axillary dissection and aortic arch damage. For left/right axillary approach, ensure there is flow in Left Internal Mammary Artery (LIMA)/Right Internal Mammary Artery (RIMA) during procedure and monitor pressure in homolateral radial artery. Residual mean gradient may be higher in a “THV-in-failing prosthesis” configuration than that observed following implantation of the valve inside a native aortic annulus using the same size device. Patients with elevated mean gradient post procedure should be carefully followed. It is important that the manufacturer, model and size of the preexisting prosthesis be determined, so that the appropriate valve can be implanted and a prosthesis-patient mismatch be avoided. Additionally, pre-procedure imaging modalities must be employed to make as accurate a determination of the inner diameter as possible.

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; stroke/transient ischemic attack, clusters, or neurological deficit; paralysis; permanent disability; respiratory insufficiency or respiratory failure; hemorrhage requiring transfusion or intervention; cardiovascular injury including perforation or dissection of vessels, ventricle, atrium, septum, myocardium, or valvular structures that may require intervention; pericardial effusion or cardiac tamponade; thoracic bleeding; 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 which may require a permanent pacemaker; arrhythmia; retroperitoneal bleed; arteriovenous (AV) fistula or pseudoaneurysm; reoperation; ischemia or nerve injury or brachial plexus injury; restenosis; 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; syncope; pain or changes (e.g., wound infection, hematoma, and other wound care complications) at the access site; exercise intolerance or weakness; inflammation; angina; heart murmur; and fever. Additional potential risks associated with the use of the valve, delivery system, and/or accessories include: cardiac arrest; cardiogenic shock; emergency cardiac surgery; cardiac failure or low cardiac output; coronary flow obstruction/transvalvular flow disturbance; device thrombosis requiring intervention; valve thrombosis; device embolization; device migration or malposition requiring intervention; left ventricular outflow tract obstruction; valve deployment in unintended location; valve stenosis; 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); device degeneration; paravalvular or transvalvular leak; valve regurgitation; hemolysis; device explants; nonstructural dysfunction; mechanical failure of delivery system and/or accessories; and non-emergent reoperation.

Edwards Crimper

Indications:  The Edwards crimper is indicated for use in preparing the Edwards SAPIEN 3 transcatheter heart valve, Edwards SAPIEN 3 Ultra transcatheter heart valve, and the Edwards SAPIEN 3 Ultra RESILIA transcatheter heart valve for implantation.

Contraindications:  There are 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 the Edwards crimper prior to THV implantation, refer to the THV Instructions for Use.

Potential Adverse Events:  There are no known potential adverse events associated with the Edwards crimper.

CAUTION: Federal (United States) law restricts these devices to sale by or on the order of a physician.

Edwards PASCAL Precision Transcatheter Valve Repair System

Indications:  The PASCAL Precision transcatheter valve repair system (the PASCAL Precision system) is indicated for the percutaneous reduction of significant, symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus (degenerative MR) in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the MR.

Contraindications:  The PASCAL Precision system is contraindicated in patients with the following conditions: patients who cannot tolerate procedural anticoagulation or post procedural anti-platelet regimen; untreatable hypersensitivity or contraindication to nitinol alloys (nickel and titanium) or contrast media; active endocarditis of the mitral valve; rheumatic etiology for mitral regurgitation; evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus.

Warnings:  The devices are designed, intended, and distributed for single use only. There are no data to support the sterility, non-pyrogenicity, and functionality of the devices after reprocessing. Devices should be handled using standard sterile technique to prevent infection. Do not expose any of the devices to any solutions, chemicals, etc., except for the sterile physiological and/or heparinized saline solution. Irreparable damage to the device, which may not be apparent under visual inspection, may result. Do not use any of the devices in the presence of combustible or flammable gases, anesthetics, or cleaners/disinfectants. Do not use the devices if the expiration date has elapsed. Do not use if the packaging seal is broken or if the packaging is damaged for sterile devices. Do not use if any of the devices were dropped, damaged or mishandled in any way. Standard flushing and de-airing technique should be used during preparation and throughout procedure to prevent air embolism.

As with any implanted medical device, there is a potential for an adverse immunological response. Serious adverse events, sometimes leading to surgical intervention and/or death, may be associated with the use of this system ("Potential Adverse Events"). A full explanation of the benefits and risks should be given to each prospective patient before use. Careful and continuous medical follow-up is advised so that implant-related complications can be diagnosed and properly managed. Anticoagulation therapy must be determined by the physician per institutional guidelines.

Precautions:  Prior to use, patient selection should be performed by a heart team to assess patient risk and anatomical suitability. After use, short-term anticoagulation therapy may be necessary after valve repair with the PASCAL Precision system. Prescribe anticoagulation and other medical therapy per institutional guidelines.

Potential Adverse Events:  Below is a list of the potential adverse effects (e.g., complications) associated with the use of the PASCAL Precision system: death; abnormal lab values; allergic reaction to anesthetic, contrast, heparin, Nitinol; anemia or decreased hemoglobin (may require transfusion); aneurysm or pseudoaneurysm; angina or chest pain; anaphylactic shock; arrhythmias - atrial (i.e. atrial fibrillation, Supraventricular tachycardia); arrhythmias - ventricular (i.e. ventricular tachycardia, ventricular fibrillation); arterio-venous fistula; atrial septal injury requiring intervention; bleeding; cardiac arrest; cardiac failure; cardiac injury, including perforation; cardiac tamponade/pericardial effusion; cardiogenic shock; chordal entanglement or rupture that may require intervention; coagulopathy, coagulation disorder, bleeding diathesis; conduction system injury which may require permanent pacemaker; deep vein thrombosis (DVT); deterioration of native valve (e.g., leaflet tearing, retraction, thickening); dislodgement of previously deployed implant; dyspnea; edema; electrolyte imbalance; emboli/embolization including air, particulate, calcific material, or thrombus; endocarditis; esophageal irritation; esophageal perforation or stricture; exercise intolerance or weakness; failure to retrieve any PASCAL Precision system components; fever; gastrointestinal bleeding or infarct; heart failure; hematoma; hemodynamic compromise; hemolysis; hemorrhage requiring transfusion or intervention; hypertension; hypotension; implant deterioration (wear, tear, fracture, or other); implant embolization; implant malposition or failure to deliver to intended site; implant migration; implant thrombosis; infection; inflammation; LVOT obstruction; mesenteric ischemia; multi-system organ failure; myocardial infarction; native valve injury; native valve stenosis; nausea and/or vomiting; need for open surgery (conversion, emergent or nonemergent reoperation, explant), nerve injury neurological symptoms, including dyskinesia, without diagnosis of TIA or stroke; non-neurological thromboembolic events; pain; papillary muscle damage; paralysis; PASCAL Precision system component(s) embolization; peripheral ischemia; permanent disability; pleural effusion; pulmonary edema; pulmonary embolism; reaction to anti-platelet or anticoagulation agents; renal failure; renal insufficiency; respiratory compromise, respiratory failure, atelectasis, pneumonia - may require prolonged ventilation; retroperitoneal bleed; septal damage or perforation; septicemia, sepsis; skin burn, injury or tissue changes due to exposure to ionizing radiation; single leaflet device attachment (SLDA); stroke; syncope; transient ischemic attack (TIA); urinary tract infection and/or bleeding; valvular regurgitation; vascular injury or trauma, including dissection or occlusion; vessel spasm; ventricular wall damage or perforation; worsening native valve regurgitation / valvular insufficiency; worsening of heart failure; wound dehiscence, delayed or incomplete healing.

Edwards EVOQUE Tricuspid Valve Replacement System

Indications:  The EVOQUE tricuspid valve replacement system is indicated for the improvement of health status in patients with symptomatic severe tricuspid regurgitation despite being treated optimally with medical therapy for whom tricuspid valve replacement is deemed appropriate by a Heart Team.

Contraindications:  The EVOQUE valve is contraindicated for patients with any of the following conditions: active endocarditis or other active infection requiring antibiotic therapy (oral or intravenous); untreatable hypersensitivity or contraindication to any of the following: all antiplatelets, all anticoagulants, nitinol alloys (nickel and titanium), bovine tissue, glutaraldehyde, contrast media, or transesophageal echocardiography; tricuspid valve anatomy that precludes proper device deployment and functionality based on CT and echocardiographic evaluation. Note: Patient must be able to tolerate at least one antiplatelet medication AND one anticoagulant medication.

Warnings:  The EVOQUE valve, delivery system, loading system, dilator kit, and stabilizer are designed, intended, and distributed for STERILE single use only. The base and plate are provided nonsterile for single use only. Do not resterilize or reuse any of the devices. There are no data to support the sterility, nonpyrogenicity, or functionality of the devices after reprocessing. Ensure proper sterile techniques are utilized during the preparation, transfer, and use of the devices. Do not use the valve if the tamper evident seal is broken, the storage solution does not completely cover the valve, the temperature indicator has been activated, the valve is damaged, or the expiration date has elapsed. The EVOQUE valve must remain hydrated at all times. The valve cannot be exposed to solutions, antibiotics, or chemicals other than its shipping storage solution and sterile physiologic saline solution. This will help prevent leaflet damage that may impact valve functionality. Keep the EVOQUE valve hydrated with normal saline until ready for implantation. Ensure the correct valve size is selected. Implantation of the improper size (i.e., undersizing or oversizing) may lead to paravalvular leak (PVL), migration, embolization, and/or annular damage.

Patients with previously-implanted devices (e.g., IVC filter) should be carefully assessed prior to insertion of the delivery system to avoid potential damage to vasculature or a previously-implanted device. Patients with pre-existing cardiac leads should be carefully assessed prior to implantation to avoid potential adverse interaction between devices. Care should be taken when implanting cardiac leads after EVOQUE valve implantation to avoid potential adverse interaction between the devices. Patients implanted with the EVOQUE valve should be maintained on anticoagulant/antiplatelet therapy as determined by their physicians in accordance with current guidelines, to minimize the risk of valve thrombosis or thromboembolic events. be diagnosed and properly managed. Anticoagulation therapy must be determined by the physician per institutional guidelines.

There are no data to support device safety and performance if the patient has: echocardiographic evidence of severe right ventricular dysfunction; pulmonary arterial systolic pressure (PASP) > 70 mmHg by echo Doppler; a trans- tricuspid pacemaker or defibrillator lead that has been implanted in the RV within the last 3 months; or dependency on a trans-tricuspid pacemaker without alternative pacing options.

Precautions:  Prior to use, the patient’s eligibility depends on the anatomic conditions based on CT scan. It is advised that a multi-disciplinary heart team be of the opinion that EVOQUE valve implantation is preferable to alternative percutaneous device solutions, including minimally-invasive open heart surgery. It is advised that a multi-disciplinary heart team takes into consideration the severity of disease and the chances of reversibility of right heart failure based on a complete hemodynamic assessment.

The EVOQUE valve is to be used only with the 9850TDS delivery system and 9850LS loading system. The procedure should be conducted under appropriate imaging modalities, such as transesophageal echocardiography (TEE), fluoroscopy, and/or intracardiac echocardiography (ICE). 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, seek immediate medical attention. For more information about glutaraldehyde exposure, refer to the Safety Data Sheet available from Edwards Lifesciences. Conduction disturbances may occur before, during, or following implantation of the EVOQUE valve, which may require continuous ECG monitoring before hospital discharge. If a patient has confirmed or suspected conduction disturbances, consider patient monitoring and/or electrophysiology evaluation. Appropriate antibiotic prophylaxis is recommended post-procedure in patients at risk for prosthetic valve infection and endocarditis. Long-term durability has not been established for the EVOQUE valve. Regular medical follow-up is advised to evaluate EVOQUE valve performance. Implantation of the EVOQUE valve should be postponed in patients with (1) a history of myocardial infarction within one month (30 days) of planned intervention, (2) pulmonary emboli within 3 months (90 days) of planned intervention, (3) cerebrovascular accident (stroke or TIA) within 3 months (90 days) of planned intervention, (4) active upper GI bleeding within 3 months (90 days) prior to procedure requiring transfusion.

Potential Adverse Events:  Potential adverse events related to standard cardiac catheterization, use of anesthesia, the EVOQUE valve, and the implantation procedure include: death; abnormal lab values; allergic reaction to anesthesia, contrast media, anti-coagulation medication, or device materials; anaphylactic shock; anemia or decreased hemoglobin (Hgb), may require transfusion; aneurysm or pseudoaneurysm; angina or chest pain; arrhythmia – atrial (i.e., atrial fibrillation, supraventricular tachycardia); arrhythmias – ventricular (i.e., ventricular tachycardia, ventricular fibrillation); arterio-venous fistula; bleeding; cardiac arrest; cardiac (heart) failure; cardiac injury, including perforation; cardiac tamponade / pericardial effusion; cardiogenic shock; chordal entanglement or rupture that may require intervention; coagulopathy, coagulation disorder, bleeding diathesis; conduction system injury, which may require implantation of a pacemaker (temporary or permanent); conversion to open heart surgery; coronary artery occlusion; damage to or interference with function of pacemaker or implantable cardioverter defibrillator (ICD); edema; electrolyte imbalance; embolization including air, particulate, calcific material, or thrombus; emergent cardiac surgery; endocarditis; esophageal irritation; esophageal perforation or stricture; EVOQUE system component(s) embolization; failure to retrieve any EVOQUE system components; fever; gastrointestinal bleeding; hematoma; hemodynamic compromise; hemolysis / hemolytic anemia; hemorrhage requiring transfusion/surgery; hypertension; hypotension; inflammation; injury to the tricuspid apparatus including chordal damage, rupture, papillary muscle damage; local and systemic infection; mesenteric ischemia or bowel infarction; multi-system organ failure; myocardial infarction; nausea and/or vomiting; nerve injury; neurological symptoms, including dyskinesia, without diagnosis of TIA or stroke; non-emergent reoperation; pain; pannus formation; paralysis; percutaneous valve intervention; peripheral ischemia; permanent disability; pleural effusion; pneumonia; pulmonary edema; pulmonary embolism; reaction to anti-platelet or anticoagulation agents; rehospitalization; renal failure; respiratory failure, atelectasis – may require prolonged intubation; retroperitoneal bleed; right ventricular outflow tract (RVOT) obstruction; septicemia, sepsis; skin burn, injury, or tissue changes due to exposure to ionizing radiation; stroke; structural deterioration (wear, fracture, calcification, leaflet tear, leaflet thickening, stenosis of implanted device, or new leaflet motion disorder); thromboembolism; transient ischemic attack (TIA); valve dislodgement/embolization; valve endocarditis; valve explant; valve leaflet entrapment; valve malposition; valve migration; valve paravalvular leak (PVL); valve regurgitation (new or worsening tricuspid, aortic, mitral, pulmonary); valve thrombosis; vascular injury or trauma, including dissection or occlusion; vessel spasm ; wound dehiscence, delayed or incomplete healing.

INSPIRIS RESILIA aortic valve

Indications: For use in replacement of native or prosthetic aortic heart valves.

Contraindications: There are no known contraindications with the use of the INSPIRIS RESILIA aortic valve.

Complications and Side Effects:Thromboembolism, valve thrombosis, hemorrhage, hemolysis, regurgitation, endocarditis, structural valve deterioration, nonstructural dysfunction, stenosis, arrhythmia, transient ischemic attack/stroke, congestive heart failure, myocardial infarction, any of which could lead to reoperation, explantation, permanent disability, and death.

Warnings: DO NOT ADJUST THE VALVE DIAMETER BY EXPANDING THE BAND PRIOR TO/OR DURING IMPLANTATION OF THE SURGICAL VALVE. The expandable band is not designed to allow for compression or expansion during implantation of the surgical valve. This will cause damage to the valve and may result in aortic incompetence. DO NOT PERFORM STAND-ALONE BALLOON AORTIC VALVULOPLASTY PROCEDURES ON THIS VALVE FOR THE SIZES 19 – 25 mm as this may expand the valve causing aortic incompetence, coronary embolism or annular rupture. Valve-in-valve sizing in the INSPIRIS valve has only been tested with specific Edwards transcatheter heart valves. Use of other transcatheter valves may result in embolization of transcatheter devices anchored within or result in annular rupture.

Caution: Federal (United States) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information.

HemoSphere Advanced Monitor Platform

Caution: Federal (United States) law restricts these devices to sale by or on the order of a physician.

See Instructions For Use (IFU) / Directions For Use (DFU) for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.