Last month, Medtronic announced receipt of U.S. Food and Drug Administration (FDA) approval for and launch of the Evolut Pro+ TAVR (Transcatheter Aortic Valve Replacement) System to treat patients with symptomatic severe aortic stenosis. Aortic stenosis is characterized by stiff, often thickened aortic valve leaflets that struggle to open and close, requiring the heart to work harder to pump blood throughout the body. Chronic, untreated patients risk death from heart failure.
Building on the already successful Evolut TAVR platform, the new offering provides four valve sizes (23, 26, 29, and 34mm), the lowest available delivery profile for placement (5.0 and 6.0mm access vessels), and an external pericardial tissue wrap that improves sealing across a wider range of patient anatomical variations. According to Dr. Guilherme Attizzani, interventional cardiologist and Director of the Valve and Structural Heart Disease Center at University Hospitals in Cleveland, “Adding the external tissue wrap to the large 34mm valve size, which wasn’t previously available, is a major technological improvement that will benefit many patients with larger anatomies.”
The FDA also recently expanded approval for the Evolut TAVR System to treat patients with low risk for surgical mortality, adding to previously approved use for exteme, high, and intermediate risk tiers. The expanded approval is expected to lead to more frequent use of TAVR for symptomatic severe aortic stenosis. “As TAVR becomes a preferred treatment option for more patients with severe aortic stenosis, it’s critically important to have valve technology available that keeps pace with the evolution of the therapy,” corroborates Dr. Mathew R. Williams, Director of the Heart Valve Program at NYU Langone Health in New York City.
To learn more about Medtronic’s new offering, Medgadget had a chance to hear from Dr. Pieter Kappetein, Vice President and Chief Medical Officer of Medtronic’s Structural Heart and Cardiac Surgery business.
Medgadget: Thank you for taking the time to speak with us. First off, can you shed some light on the clinical importance of transcatheter aortic valve replacement (TAVR) compared to the previous standard of care or other methods of treating aortic stenosis?
Dr. Pieter Kappetein: Options for treating severe symptomatic aortic stenosis (ssAS) include open-heart Surgical Aortic Valve Replacement (SAVR) and Transcatheter Aortic Valve Replacement (TAVR). SAVR had been long considered the gold standard for treating severe symptomatic aortic stenosis, especially in those healthy enough to undergo a surgical operation. However, with the emergence of TAVR and its availability to a broader range of patients over time (recently, the FDA approved TAVR to treat patients at low risk of surgical mortality), heart teams and patients now have an alternative treatment option to consider; a treatment that is less invasive than traditional valve replacement surgery. This signals an important shift in the future treatment of heart valve disease as healthcare providers will have options – both of which have risks and benefits – and will be able to make treatment decisions that are in the best interest of each patient’s individual needs.
Medgadget: What has been Medtronic’s history in the TAVR market?
Dr. Kappetein: Medtronic began developing solutions to treat diseases affecting the structure of the heart in 1977, with the introduction of a revolutionary mechanical heart valve that had no welds, joints, or bends that could eventually weaken the valve’s structure. Since then, the business has expanded into heart valve repair, tissue valves, and the world’s first transcatheter valve in 2006.
TAVR began at Medtronic in 2009 when the business acquired the CoreValve self-expanding TAVR system following its launch in Europe in 2007. In 2016, Medtronic launched its third-generation (Evolut PRO) TAVR system with recapturable and repositionable capabilities and advanced sealing. Evolut PRO+ is the latest generation TAVR system which launched in the U.S. in September 2019.
Medhadhey: As of last month, the Evolut TAVR System is now approved for all risk categories of patients with aortic stenosis (extreme, high, intermediate, and low). Can you clarify the distinction between the Evolut TAVR Platform and the Evolut PRO+ TAVR System?
Dr. Kappetein: The Evolut PRO+ TAVR System is the new-generation TAVR platform from Medtronic designed to improve upon the existing Evolut system for treatment of ssAS patients. Built on the proven self-expanding Evolut platform, PRO+ features four valve sizes and the smallest delivery profile currently on the market:
- Four valve sizes (23mm, 26mm, 29mm and 34mm) with an external tissue wrap that increases surface contact area with the native anatomy for advanced sealing across the broadest range of patient anatomies
- A lower delivery profile for 23-29mm valves to be placed through 5.0mm access vessels (6.0mm for 34mm), expanding access to more patients and improving procedural safety for lower risk of vascular complication
Medgadget: How does the Evolut PRO+ TAVR System compare to other similar solutions on the market and what impact is the technology’s entry into the market expected to have?
Dr. Kappetein: A few different features set the Evolut PRO+ TAVR System apart from other TAVR technologies:
- A Self-expanding nitinol frame conforms to the native annulus with consistent radial force, resulting in enhanced valve sealing
- The External tissue wrap increases surface area contact with native anatomy and promotes tissue interaction designed to reduce incidences of paravalvular leak
- For the first time, the extended tissue wrap has been added to the larger 34mm valve size for patients with larger anatomies
- Unmatched hemodynamic (blood flow) performance versus SAVR, which is due to several factors, including:
- Sustained large EOAs (effective orifice area) and low mean gradients over time
- Large EOAs promote increased blood flow and minimizes sizing mismatch, which helps patients maintain better blood flow, enabling them to get back to everyday life. This is especially important for low-risk patients who may be slightly younger or more active than older ssAS patients too sick for surgical valve procedures.
Medgadget: To close, what’s next for Medtronic in the TAVR market?
Dr. Kappetein: This is an exciting time for heart valve innovation, and in addition to bringing new technologies to the market such as Evolut PRO+, we are also committed to generating significant clinical and economic evidence for the therapy. This includes continued follow up in the Evolut Low Risk Trial, Low Risk Bicuspid, among others. We also have resources dedicated to R&D efforts for the next phase in TAVR innovation which involves fine-tuning the system for even better deliverability, positioning accuracy, and visualization, while looking at ways to improve coronary access and pacemaker rates. Medtronic is in a position to help lead the future of heart valve innovation and we are excited about the opportunities to help treat more patients in the future.
Product page: Evolut PRO+ transcatheter aortic valve system