Abbott has hit the ground running in 2023, announcing a key addition to its structural heart portfolio in the U.S.
Meet Navitor, the company’s latest-generation transcatheter aortic valve implantation (TAVI) system.
Navitor’s recent approval by the U.S. Food and Drug Administration not only bolsters Abbott’s structural heart portfolio — which is the most comprehensive in the U.S.1 — but also solidifies the company’s competitiveness in the TAVI market, the largest structural heart market, about $3 billion U.S. in 2022 and growing.2
And there’s more.
Navitor — which is designed to help open a narrowed aortic valve in people with severe aortic stenosis, one of the most common and life-threatening heart valve diseases — gives physicians another minimally-invasive treatment option for people who are at a high or extreme risk for complications from open-heart surgery.
This next-gen technology follows Abbott’s 2021 entry into the U.S. TAVI market with the Portico with FlexNav TAVI system and builds on the company’s industry-leading portfolio of minimally invasive devices.
Navitor received CE Mark in 2021 for people in Europe with severe aortic stenosis at high or extreme surgical risk.
Adding to the momentum are recent data on one-year outcomes showing the safety and effectiveness of Navitor for people with severe aortic stenosis.
“The FDA’s approval of Navitor is a major next step in our mission to help people live better lives through better health,” said Michael Dale, senior vice president of Abbott's structural heart business. “The Navitor system will continue to enhance minimally invasive treatment options for people with structural heart disease and offer hope to patients who may not have other treatment choices.”
Navitor’s Competitive Advantage
Abbott’s Navitor system stands out from the competition with its unique fabric cuff that reduces or eliminates the backflow of blood around the valve frame, a common complication following TAVI procedures.
Navitor is the only self-expanding TAVI system with leaflets within the native valve, a design that can make it easier for physicians to access a person’s coronary arteries for future procedures to treat coronary artery disease. The system’s design also provides excellent blood flow through the aortic valve, which is important for cardiovascular health.
Learn more about the Navitor system and get insight on other key health technologies in the company’s new product pipeline.
References
1Internal data at Abbott.
2Barclays 2023 Outlook report.
IMPORTANT SAFETY INFORMATION
NAVITORTM TRANSCATHETER AORTIC VALVE IMPLANTATION SYSTEM
Rx Only
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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