PharmaShots Interview: Abbott’s Michael Dale Shares Insight on the CE Mark for the Next-Generation Navitor TAVI System

In an interview with PharmaShots, Michael Dale, Senior Vice President of the Structural Heart division at Abbott shared his views on the Navitor’s approval in the EU for patients with severe aortic stenosis who are at high or extreme surgical risk for open-heart surgery.

Shots:

• Abbott has received CE Mark approval for its latest-generation transcatheter aortic valve implantation (TAVI/TAVR) system, Navitor which is a minimally invasive device available for people in EU with severe aortic stenosis who are at high or extreme surgical risk for open-heart surgery
• Navitor is designed to help improve access to critical coronary arteries to facilitate future interventions to treat coronary artery disease (CAD)
• Paired with Abbott’s FlexNav delivery system and a unique fabric cuff (NaviSeal) that works with the cardiac cycle to reduce or eliminate a backflow of blood around the valve frame, Navitor address the challenges that physicians face in current TAVI systems when encountering complex patient anatomies

Tuba: Discuss the approval of the Navitor latest-generation TAVI System in detail.

Michael: We recently (May 2021) announced CE Mark approval for our Navitor™ transcatheter aortic valve implantation system (TAVI/TAVR), which is our latest-generation advancement to our TAVI offering outside of the U.S. CE Mark designation allows us to make Navitor available throughout the EU and offers a minimally invasive treatment option for patients with severe aortic stenosis who are at high or extreme surgical risk. Aortic stenosis is a life-threatening condition that occurs when the aortic valve stiffens secondary to disease, impeding the pumping of oxygenated blood from the heart to the rest of the body.

Tuba: What does this approval mean to the countries accepting CE Mark approval?

Michael: As our world population ages and aortic stenosis cases continue to increase, Navitor’s innovative technology is all the more critical and its entry into the European market is timely for the patients who need access to this type of therapy. The CE Mark announcement means that the minimally invasive Navitor TAVI system is now available to physicians and patients in these countries for the treatment of the life-threatening aortic stenosis heart condition. Navitor also pairs with our leading FlexNav delivery system which enables better placement accuracy and improved patient outcomes during the TAVI procedure.

Tuba: How does this technology treating aortic stenosis prove to be remarkable?

Michael: Open-heart surgery can be a high-risk procedure for some people with severe aortic stenosis because of potential complications related to age, frailty, or having multiple other diseases or conditions. The Navitor TAVI procedure is a less invasive alternative to surgical aortic valve replacement that helps patients with this debilitating condition get back to living their best lives through better health.

With Navitor, Abbott is advancing TAVI therapies with advancements including a unique design to prevent blood leakage around the valve. It also offers best-in-class deliverability and access through small vessels, expanding treatment options for patients with severe aortic stenosis.

Tuba: What are the major differences and impacts this new generation transcatheter will have on people and how is it different from its previous generations?

Michael: The objective of a transcatheter aortic valve procedure is to restore normal aortic valve hemodynamics, or blood flow, at the lowest possible risk. Physicians sometimes encounter challenges and complications when using current TAVI systems to treat patients with complex anatomies. Abbott sought to develop solutions to address the most critical of these issues: large frame cells to preserve future access to the coronary arteries and optimal hemodynamics, or blood flow, through the replacement valve during the procedure. Navitor is implanted with Abbott’s FlexNav Delivery System, which received CE Mark in 2020 and offers the smallest TAVI delivery system with a slim profile to allow accurate valve placement for different aortic anatomies – even for people with unusually small vessels.

Tuba: How will this CE approval help Abbott to go further in the advancement of TAVI procedures and help treat people who have life-threatening heart conditions?

Michael: We are constantly working on new options and improvements to our life-changing technologies. The addition of Navitor strengthens Abbott’s portfolio of structural heart transcatheter offerings that provide less invasive alternatives to treat debilitating heart diseases with previously few treatment options.

Tuba: Discuss the features of this new TAVI system.

Michael: Navitor’s innovative features include a unique fabric cuff, NaviSeal, that reduces or eliminates the risk of blood leakage around the valve implant, a common complication following TAVI procedures. It’s the only self-expanding TAVI system with intra-annular (within the native valve) leaflets and large frame cells, which help improve access to critical coronary arteries to facilitate future interventions to treat coronary artery disease (CAD). The device’s design additionally provides improved hemodynamics or better blood flow. 

Tuba: What are Abbott’s other efforts for improving the lives of patients with life-threatening heart conditions?

Michael: As the world’s population proportionately ages, there’s an increasing need to treat structural heart conditions, which are mostly related to degenerative disease and the aging process, but also include congenital heart defects secondary to incomplete development of the child’s heart in utero. Following advancements and improvements in real-time imaging technologies, minimally invasive treatment solutions – which are often simpler and safer – have grown to become one of the fastest-growing technology segments in cardiac care. Abbott has the most comprehensive portfolio of solutions for the treatment of structural heart diseases including devices and tools for the repair or replacement of diseased or damaged heart valves, and occlusion devices for closing heart defects in children and areas of blood clots formation that can lead to stroke in adults.

Notable within our structural heart portfolio, we offer minimally invasive therapies like our leading MitraClip device that is the world’s first transcatheter mitral valve repair therapy. To date, MitraClip has helped treat more than 150,000 patients worldwide suffering from mitral regurgitation, or a leaky mitral valve. For patients whose mitral valves cannot be repaired, we have developed the Tendyne transcatheter mitral valve replacement system, which has been approved in the EU since early 2020. Recently, we have expanded clip therapy technology for the treatment of tricuspid valve regurgitation, which is the most undertreated valve disease, with our TriClip device, also been approved in Europe since 2020.

We’re also focused on making devices for our smallest, most vulnerable patients to address heart defects in high-risk babies and children, as seen through our Amplatzer Piccolo Occluder and Masters HP 15mm Mechanical Heart Valve. Our growing stroke mitigation portfolio includes the Amplatzer Amulet device (approved outside the U.S. currently) for closing the left atrial appendage and our Amplatzer PFO Occluder device for treating cryptogenic stroke. We are the leaders in the treatment of life’s most challenging structural heart diseases. 

Beyond structural heart, no company in the world today expands the boundaries of cardiovascular innovation like Abbott or offers such comprehensive solutions across the patient’s healthcare journey.

Diseases of the heart are complex, and success depends on innovation that brings to reality treatment options once thought impossible. Abbott covers the continuum of cardiovascular care –from diagnosis to treatment to management – pioneering comprehensive solutions to tackle the cardiovascular disease from every angle. 

We’re building a true care continuum for patients, significantly improving the treatment of cardiovascular diseases.

Tuba: What motivates the company to work on transcatheter? How can you say that it will transform people’s lives?

Michael: At Abbott, we help people live better lives through better health. And we do this across all our businesses – diagnostic, nutrition, established pharmaceuticals, and our medical device businesses. In Abbott’s structural heart business, our purpose is to restore health and improve quality of life by developing devices and services for the treatment of structural heart disease. The measure of success in our work is whether our devices provide greater benefit versus risk as compared to existing standards of care.

Navitor is a great example of this because it represents the culmination of years of work to bring a better benefit-to-risk profile to patients needing a TAVI procedure as compared to existing choices. Navitor’s ease-of-use, deliverability, safety, and outstanding hemodynamic performance make it a better solution for many situations. As with any of our products to treat structural heart disease, we measure our success based on the benefit-to-risk profile for our minimally invasive, transcatheter therapies as compared to the existing standards of care including surgical procedures. This is an important metric and performance threshold we use to guide and ensure that the output of our engineering, business development, and clinical research efforts results in outcomes that advance the standard of care.

We see a big future focused on the treatment of cardiovascular conditions and we are excited to be at the forefront with the most comprehensive portfolio of minimally invasive structural heart offerings in the world.   

Tuba: When can we expect the approval of the Navitor Transcatheter Aortic Valve in the US and other geographies?

Michael: While we haven’t publicly shared timelines, we are pursuing additional approvals in other countries, including the US

Source: Neurology Advisor

About Author:

Michael Dale is Senior Vice President of the Structural Heart division at Abbott. Mr. Dale holds a Bachelor of Science degree from California Polytechnic State University in San Luis Obispo, California.