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MITRACLIP™ CLIP DELIVERY SYSTEM

INDICATIONS FOR USE

The MitraClip™ G5 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 mitral regurgitation.

The MitraClip™ G5 System, when used with maximally tolerated guideline-directed medical therapy (GDMT), is indicated for the treatment of symptomatic, moderate-to-severe or severe secondary (or functional) mitral regurgitation (MR; MR ≥ Grade III per American Society of Echocardiography criteria) in patients with a left ventricular ejection fraction (LVEF) ≥ 20% and ≤ 50%, and a left ventricular end systolic dimension (LVESD) ≤ 70 mm whose symptoms and MR severity persist despite maximally tolerated GDMT as determined by a multidisciplinary heart team experienced in the evaluation and treatment of heart failure and mitral valve disease.

CONTRAINDICATIONS

The MitraClip™ G5 System is contraindicated for use in patients with the following conditions:

• Intolerance, including allergy or untreatable hypersensitivity, to procedural anticoagulation
• Untreatable hypersensitivity to Implant components (nickel- titanium alloy, cobalt-chromium alloy)
• Active endocarditis or other active infection of the mitral valve 

POTENTIAL COMPLICATIONS AND ADVERSE EVENTS

The following events have been identified as possible complications of the MitraClip™ G5 procedure:
Allergic reactions or hypersensitivity to latex, contrast agent, anaesthesia, device materials, and drug reactions to anticoagulation, or antiplatelet drugs, additional treatment/surgery from device-related complications, atrial septal defect, bleeding, blood disorders (including coagulopathy, hemolysis, and Heparin Induced Thrombocytopenia (HIT)), Cardiac arrhythmias (including conduction disorders, atrial arrhythmias, ventricular arrhythmias), Cardiac ischemic conditions (including myocardial infarction, myocardial ischemia, unstable angina, and stable angina), Cardiac perforation, Cardiac tamponade, chest pain, death, Dyspnea, Edema, Embolization (device or components of the device), Endocarditis, fever or hyperthermia, Fluoroscopy and Transesophageal echocardiogram (TEE) -related complications: Skin injury or tissue changes due to exposure to ionizing radiation, Esophageal irritation, Esophageal perforation, Gastrointestinal bleeding, Hypotension / hypertension; Infection including: Septicemia; Mitral valve complications, which may complicate or prevent later surgical repair, including: Chordal entanglement / rupture, Single leaflet device attachment (SLDA), dislodgement of previously implanted devices, tissue damage, mitral valve stenosis, worsening, persistent or residual regurgitation, nausea or vomiting, pain, Pericardial effusion, stroke / cerebrovascular accident (CVA) and transient ischemic attack (TIA), system organ failure: cardio-respiratory arrest, worsening heart failure, Pulmonary congestion, Respiratory dysfunction or failure or atelectasis, Renal insufficiency or failure, Shock (including cardiogenic and anaphylactic), Thrombosis, Vascular access complications which may require additional intervention, including: wound dehiscence, bleeding of the access site, Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection, perforation (rupture), vascular occlusion, Embolism (air, thrombus), Peripheral nerve injury, Venous thrombosis (including deep vein thrombosis) and thromboembolism (including pulmonary embolism)

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TRICLIP™ G5 SYSTEM

INDICATIONS

The TriClip™ G5 System is indicated for improving quality of life and functional status in patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy, who are at intermediate or greater risk for surgery and in whom transcatheter edge-to-edge valve repair is clinically appropriate and is expected to reduce tricuspid regurgitation severity to moderate or less, as determined by a multidisciplinary heart team.

CONTRAINDICATIONS

The TriClip™ G5 System is contraindicated for use in patients with the following conditions: Intolerance, including allergy or untreatable hypersensitivity, to procedural anticoagulation; Untreatable hypersensitivity to Implant components (nickel-titanium alloy, cobalt-chromium alloy); Active endocarditis or other active infection of the tricuspid valve.

POTENTIAL ADVERSE EVENTS

The following events have been identified as possible complications of the TriClip™ G5 Procedure. Allergic reactions or hypersensitivity to latex, contrast agent, anaesthesia, device materials and drug reactions to anticoagulation, or antiplatelet drugs; Additional treatment / surgery from device-related complications; Bleeding; Blood disorders (including coagulopathy, hemolysis, and Heparin Induced Thrombocytopenia (HIT)); Cardiac arrhythmias (including conduction disorders, atrial arrhythmias, ventricular arrhythmias); Cardiac ischemic conditions (including myocardial infarction, myocardial ischemia, unstable angina, and stable angina); Cardiac perforation; Cardiac tamponade; Chest pain; Death; Dyspnea; Edema; Embolization (device or components of the device); Endocarditis; Fever or hyperthermia; Fluoroscopy and Transesophageal echocardiogram (TEE) -related complications: Skin injury or tissue changes due to exposure to ionizing radiation, Esophageal irritation, Esophageal perforation, Gastrointestinal bleeding; Hypotension / hypertension; Infection including: Septicemia; Nausea or vomiting; Pain; Pericardial effusion; Stroke / cerebrovascular accident (CVA) and transient ischemic attack (TIA); System organ failure: Cardio-respiratory arrest, Worsening heart failure, Pulmonary congestion, Respiratory dysfunction or failure or atelectasis, Renal insufficiency or failure, Shock (including cardiogenic and anaphylactic); Thrombosis; Tricuspid valve complications, which may complicate or prevent later surgical repair, including: Chordal entanglement / rupture, Single leaflet device attachment (SLDA), Dislodgement of previously implanted devices, Tissue damage, Tricuspid valve stenosis, Worsening, persistent or residual regurgitation; Vascular access complications which may require additional intervention, including: Wound dehiscence, Bleeding of the access site, Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection, perforation (rupture), vascular occlusion, Embolism (air, thrombus), Peripheral nerve injury; Venous thrombosis (including deep vein thrombosis) and thromboembolism (including pulmonary embolism).

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NAVITOR™ TRANSCATHETER AORTIC VALVE IMPLANTATION SYSTEM

INDICATIONS

The Navitor™ Transcatheter Aortic Valve Implantation 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 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 comorbidities unmeasured by the STS risk calculator).

CONTRAINDICATIONS  

The valve is contraindicated for patients with inability to tolerate antiplatelet/anticoagulant therapy or nitinol alloy (nickel and titanium), or who have active infections, including endocarditis.

POTENTIAL ADVERSE EVENTS  

Adverse events potentially associated with the use of transcatheter bioprosthetic heart valves include but are not limited to: access site complications (e.g., pain, bleeding, infection, hematoma, pseudoaneurysm, etc.); acute coronary obstruction; acute myocardial infarction; allergic reaction to antiplatelet agents, contrast medium, or valve components; aortic rupture; ascending aorta trauma; atrio-ventricular node block; cardiac arrhythmias; conduction system injury; conversion to open surgical procedure; death; dissection; embolism; emergent balloon valvuloplasty; emergent percutaneous coronary intervention (PCI); emergent surgery (i.e., coronary artery bypass, heart valve replacement); endocarditis; explantation; heart failure; hemodynamic compromise; hemolysis; hemolytic anemia; hemorrhage; hypotension or hypertension; infection; myocardial ischemia; mitral valve insufficiency; multi-organ failure; non-structural dysfunction (i.e., entrapment by pannus, paravalvular leak, inappropriate sizing or positioning); pannus; pericardial effusion; perforation of the myocardium, ventricle, or a blood vessel; permanent disability; permanent pacemaker; regurgitation; renal insufficiency or renal failure; reoperation; respiratory failure; sepsis; stroke; structural deterioration (i.e., calcification, leaflet tear); thrombosis; tamponade; transfusion; valve embolization or migration; vessel dissection or spasm.

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TENDYNE™ TRANSCATHETER MITRAL VALVE SYSTEM

INDICATIONS FOR USE

The Tendyne™ Transcatheter Mitral Valve System is indicated for the treatment of symptomatic severe mitral valve dysfunction (moderate-to-severe or severe mitral regurgitation (MR), severe mitral stenosis (MS), or moderate MR with moderate or greater MS) associated with severe mitral annular calcification (MAC) in patients who are deemed unsuitable for mitral valve surgery or transcatheter edge-to-edge repair by a multidisciplinary heart team.

CONTRAINDICATIONS

The Tendyne™ Transcatheter Mitral Valve System is contraindicated in patients with:

• anticoagulation/antiplatelet intolerance;
• sepsis or active endocarditis;
• evidence of left ventricular or left atrial thrombus at risk of embolization;
• a thin or fragile apex rendering the subject unsuitable for a transapical procedure; or
• untreatable hypersensitivity to nickel or titanium

Patients not deemed a candidate by the local heart team based on clinical or anatomical factors should not have the Tendyne™ Transcatheter Mitral Valve procedure.

POTENTIAL COMPLICATIONS AND ADVERSE EVENTS

Adverse events potentially associated with use of the Tendyne™ Transcatheter Mitral Valve System may include, but are not limited to, the following:

Death, Adverse foreign body response, Adverse reaction to anesthesia, Allergic reaction, Anemia, Annular dissection, Aortic insufficiency, Atrial or ventricular injury, Atrial Septal Defect (resulting from transseptal mitral valvuloplasty, if performed), Bioprosthetic valve dysfunction, Bleeding complications, Blood loss which may require transfusion, Cardiac arrest, Cardiac perforation, Conduction defect with or without need for pacemaker, Cardiac arrhythmia, atrial or ventricular, Damage to cardiac tissue and/or structures, Decreased LV function and/or cardiac output, Device embolism, Device erosion, migration or malposition, Device thrombosis, Embolism (air, blood clot, calcium, tissue, etc.), Endocarditis, Esophageal irritation, stricture, or perforation, Fever, Foreign body response, Heart Failure, new or worsening, Hematoma, Hemolysis, Hypotension, Infection / Sepsis, Leaflet, chordal, papillary or ventricular rupture (resulting from mitral valvuloplasty, if performed), Liver failure, Mitral valve injury, Mitral valve prolapse / stenosis, Myocardial infarction, Obstruction, Pain, Pleural effusion, Pulmonary embolism, Pulmonary hypertension, Paravalvular leak, Pericardial effusion / tamponade, Renal insufficiency or failure, Respiratory difficulty, insufficiency or failure, Stroke or transient ischemic attack, Tear or damage to device, Vascular and access-related complications, Worsening of mitral regurgitation.