With a commitment to advancing innovative technology to ensure people living with structural heart diseases have safe and effective treatment options, Abbott reimagined the minimally invasive treatment of aortic stenosis with the Navitor TAVI** System and was the first to develop transcatheter edge-to-edge repair (TEER) therapy for patients with severe mitral regurgitation (MR) and patients with symptomatic severe tricuspid regurgitation (TR).
**TAVI is also referred to as TAVR (Transcatheter Aortic Valve Replacement)
MitraClip™ Transcatheter Edge-to-Edge Repair (TEER) procedure is a minimally invasive treatment option, uniquely designed for the mitral valve, for select patients with primary or secondary MR. As the first TEER therapy recommended by ACC/AHA1 and ESC/EACTS2-3 guidelines and by ASPC Recommendation,4 MitraClip is the standard of care in TMVr built on the only proven mitral valve therapy with over 20+ years of experience, extensive body of clinical evidence, and more than 200,000 patients treated worldwide,5 allowing physicians to treat more patients with more options.
Advancing the forefront of innovative design, the Navitor™ Transcatheter Aortic Valve Implantation (TAVI) System brings together stable delivery, remarkable performance, and a future-ready design.
TriClip™ Transcatheter Edge-to-Edge Repair (TEER) is a non-surgical treatment option for patients with symptomatic severe Tricuspid Regurgitation (TR), despite optimal medical therapy. TriClip TEER offers exceptional safety7,8 and maximized effectiveness8,9 to significantly improve quality of life (QoL) and functional status of patients with TR.
MAT-2011953 v7.0
MITRACLIP™ CLIP DELIVERY SYSTEM
Indications for Use
Contraindications
The MitraClip G4 System is contraindicated in patients with the following conditions: Patients who cannot tolerate, including allergy or hypersensitivity to, procedural anticoagulation or post procedural anti-platelet regime; Patients with known hypersensitivity to clip components (nickel / titanium, cobalt, chromium, polyester), or with contrast sensitivity; Active endocarditis of the mitral valve; Rheumatic mitral valve disease; Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus.
Potential Complications and Adverse Events
The following ANTICIPATED EVENTS have been identified as possible complications of the MitraClip G4 procedure: Allergic reactions or hypersensitivity to latex, contrast agent, anaesthesia, device materials (nickel / titanium, cobalt, chromium, polyester), and drug reactions to anticoagulation, or antiplatelet drugs, Vascular access complications which may require transfusion or vessel repair including: wound dehiscence, catheter site reactions, Bleeding (including ecchymosis, oozing, hematoma, hemorrhage, retroperitoneal hemorrhage), Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection, perforation / rupture, vascular occlusion, Emboli (air thrombotic material, implant, device component); Peripheral Nerve Injury; Lymphatic complications; Pericardial complications which may require additional intervention, including: Pericardial effuse on, Cardiac tamponade, Pericarditis; Cardiac complications which may require additional interventions or emergency cardiac surgery, including: Cardiac perforation, Atrial septal defect; Mitral valve complications, which may complicate or prevent later surgical repair, including: Chordal entanglement / rupture, Single Leaflet Device Attachment (SLDA), Thrombosis, Dislodgement of previously implanted devices, Tissue damage, Mitral valve stenosis, Persistent or residual mitral regurgitation, Endocarditis; Cardiac arrhythmias (including conduction disorders, atrial arrhythmias, ventricular arrhythmias); Cardiac ischemic conditions (including myocardial infarction, myocardial ischemia, and unstable / stable angina); Venous thromboembolism (including deep vein thrombosis, pulmonary embolism, post procedure pulmonary embolism); Stroke / Cerebrovascular accident (CVA) and Transient Ischemic Attack (TIA); System organ failure: Cardio-respiratory arrest, Worsening heart failure, Pulmonary congestion, Respiratory dysfunction / failure / atelectasis, Renal insufficiency or failure, Shock (including cardiogenic and anaphylactic); Blood cell disorders (including coagulopathy, hemolysis, and Heparin Induced Thrombocytopenia (HIT)); Hypotension / hypertension; Infection including: Urinary Tract Infection (UTI), Pneumonia, Septicemia; Nausea / vomiting; Chest pain; Dyspnea; Edema; Fever or hyperthermia; Pain; Death; Fluoroscopy, Transesophageal echocardiogram (TEE) and Transthoracic echocardiogram (TTE) -related complications: Skin injury or tissue changes due to exposure to ionizing radiation, Esophageal irritation; Esophageal perforation, Gastrointestinal bleeding.
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Important Safety Information
NAVITORTM 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.
TRICLIP™ CLIP G4 SYSTEM
INDICATIONS
The TriClip™ G4 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 G4 System is contraindicated 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 G4 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).
MAT-2402104 v1.0
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