Abbott Receives FDA Approval for Navitor™, a Next-Generation TAVI System Designed to Treat Aortic Stenosis

Rhea-AI Summary

Abbott (NYSE: ABT) announced FDA approval for its Navitor system, designed for transcatheter aortic valve implantation (TAVI) to treat severe aortic stenosis in patients at high or extreme surgical risk. The Navitor device reduces risk of blood leakage around the valve, enhancing patient care. It includes a unique NaviSeal fabric cuff to minimize paravalvular leak and is the only self-expanding TAVI system with leaflets within the native valve, improving future coronary artery access. This system supports optimal blood flow, further solidifying Abbott's strategy in minimally invasive heart disease treatments.

Positive

• FDA approval of Navitor enhances Abbott's position in the minimally invasive heart valve market.
• Navitor reduces the risk of blood leakage, improving safety and efficacy for high-risk patients.
• The device offers excellent hemodynamics, enhancing patient outcomes.

Negative

• None.

• Abbott's new Navitor device features advancements to improve patient care, including reducing or eliminating risk of blood leakage around valve implant 
• Transcatheter aortic valve implantation (TAVI) offers minimally invasive alternative to surgery for people with aortic stenosis, a common and life-threatening heart valve disease   

ABBOTT PARK, Ill., Jan. 17, 2023 /PRNewswire/ -- Abbott (NYSE: ABT) today announced that the U.S. Food and Drug Administration (FDA) has approved the company's latest-generation transcatheter aortic valve implantation (TAVI) system, Navitor™, to treat people with severe aortic stenosis who are at high or extreme risk for open-heart surgery. The Navitor TAVI system is the latest addition to the company's comprehensive transcatheter structural heart portfolio that offers less invasive treatment options to physicians and patients for some of the most common and serious heart diseases.

Aortic stenosis occurs when the aortic valve's opening narrows, restricting blood flow to the body. Left untreated, it can lead to heart failure and death. For patients with severe aortic stenosis who are at high or extreme surgical risk due to the potential complications stemming from age, frailty, or having multiple other diseases or conditions, physicians may opt for a minimally invasive procedure using TAVI therapies such as the Navitor system.

"Abbott's Navitor device features advancements to help doctors safely and effectively treat patients with aortic stenosis, including a design that reduces the backflow of blood around the valve that's often a complication following TAVI procedures," said Michael Reardon, M.D., Alison Family Distinguished Chair of Cardiovascular Research and professor of cardiothoracic surgery at the Houston Methodist Hospital, who served as principal investigator for the study that led to FDA approval. "The innovative Navitor system also offers physicians stable and accurate device placement, even in challenging patient anatomies."

Navitor features a unique fabric cuff (NaviSeal™) to reduce or eliminate the backflow of blood around the valve frame known as paravalvular leak (PVL). Additionally, the new device is the only self-expanding TAVI system with leaflets within the native valve; this design can help improve access to coronary arteries to facilitate future procedures for treating coronary artery disease. The system provides excellent hemodynamics, or blood flow, through the valve. The Navitor device is implanted using Abbott's FlexNav™ delivery system, which features a slim design to accommodate different patient anatomies and small vessels for stable, predictable and accurate valve delivery and placement.

"Our Navitor valve builds upon our industry-leading portfolio of minimally invasive devices that surpass existing standards of care to address a range of heart diseases," said Michael Dale, senior vice president of Abbott's structural heart business. "Navitor is the first TAVI system to offer optimal hemodynamics in all valve sizes while also preserving options for lifetime disease management, an important consideration for physicians and patients when selecting a TAVI solution. Receiving this approval is a major next step in our mission to help people live better lives through better health."

For U.S. important safety information on Navitor, visit https://abbo.tt/NavitorISI.

About Abbott:  
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.

 

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SOURCE Abbott

FAQ

What is the Navitor system approved by Abbott for?

The Navitor system is approved for transcatheter aortic valve implantation (TAVI) to treat severe aortic stenosis in high or extreme surgical risk patients.

What are the benefits of the Navitor device?

The Navitor device reduces or eliminates blood leakage around the valve, offers stable placement, and includes unique access features for future coronary procedures.

How does the Navitor compare to other TAVI systems?

Navitor is the only self-expanding TAVI system with leaflets within the native valve, providing improved outcomes and options for lifetime disease management.

When was the Navitor system approved by the FDA?

The FDA approval for the Navitor system was announced on January 17, 2023.

What company manufactures the Navitor device?

The Navitor device is manufactured by Abbott (NYSE: ABT).