MITRACLIP™ DELIVERY SYSTEMS
TRICLIP™ CLIP DELIVERY SYSTEM

MITRACLIP™ G5 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.

TRICLIP™ G5 SYSTEM INDICATIONS FOR USE

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.

MITRACLIP™ G5 SYSTEMS AND TRICLIP™ G5 SYSTEMS CONTRAINDICATIONS

Both the MitraClip™ G5 System and the TriClip™ G5 System are 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 or tricuspid valve.

MITRACLIP™ G5 SYSTEMS AND TRICLIP™ G5 SYSTEMS POTENTIAL COMPLICATIONS AND ADVERSE EVENTS

The following events have been identified as possible complications for both the MitraClip™ G5 and TriClip™ G5 procedures (except as noted): 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 (in MitraClip only), 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 and 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, 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).