Abbott (ABT) Makes Progress in the TAVI Space With Navitor
Abbott ABT recently announced significant progress with Navitor, the company’s latest-generation transcatheter aortic valve implantation (TAVI) system. The company announced late-breaking data for Navitor during presentations at the annual Cardiovascular Research Technologies (CRT) meeting held in Washington, D.C. (Feb 25-28, 2023).
Results from this study supported Navitor's recent FDA approval to treat people with severe aortic stenosis who are at high or extreme risk for open-heart surgery.
More About the Study
Following the development of Abbott's next-generation TAVI system, the company launched the PORTICO NG (Next Generation) study. This prospective, multicenter, international, single-arm trial supports the FDA approval of the Navitor TAVI system that was received back in January 2023.
PORTICO NG specifically demonstrates the safety of the Navitor TAVI system and its effectiveness in minimizing blood leakage around the valve implant.
In this regard, we note that the Navitor TAVI system, the latest addition to the company's comprehensive transcatheter structural heart portfolio, offers less-invasive treatment options for some of the most common and serious heart diseases.
Navitor’s unique fabric cuff (NaviSeal) is expected to reduce or eliminate the backflow of blood around the valve frame, known as the paravalvular leak. Additionally, the new device is the only self-expanding TAVI system with leaflets within the native valve. This design is expected to aid in improving access to coronary arteries to facilitate future procedures for treating coronary artery disease.
The Amplatzer Amulet LAA Update
Abbott also showcased late-breaking data for the Amplatzer Amulet Left Atrial Appendage (LAA) Occluder at the annual CRT meeting. This study highlights the benefits of this device's immediate and complete closure of the LAA for patients with atrial fibrillation (AFib) at risk of stroke.
According to the company, the Amulet IDE trial’s findings demonstrated that the Amplatzer Amulet LAA Occluder with dual-seal technology (consisting of a lobe or piece to fill the cavity of the LAA and a disc to seal off the opening into the LAA) had fewer unresolved, severe peri-device leaks (PDLs), where blood leaks around the implant, compared to Boston Scientific's BSX Watchman‡ device that has a single component to close the LAA.
Per Abbott, severe PDLs with Amulet were less commonly associated with adverse events and deaths than BSX’s Watchman.
Competitive Niche in Transcatheter Aortic Valve Space
Per a report by Allied Market Research, the global TAVI market was valued at $4,559 million in 2020 and is anticipated to reach $16,937 million by 2030 at a CAGR of 14%. Factors like the increase in the prevalence of aortic stenosis, rise in demand for various TAVI procedures and rise in the elderly population are likely to drive the market.
Boston Scientific’s WATCHMAN Left Atrial Appendage Closure Device sales grew 22% organically in the last-reported fourth quarter of 2022. Strong utilization in the United States was supported by the DAPT label expansion. Importantly, the company completed the enrollment of the CHAMPION-AF trial ahead of schedule. This head-to-head trial versus novel oral anticoagulation has the potential to more than triple the number of patients indicated for WATCHMAN FLEX in 2027 and beyond.
Edwards Lifesciences EW, within TAVR in 2022, received approval and launched the innovative SAPIEN 3 Ultra RESILIA valve. The company continued to advance enrollment in the PROGRESS pivotal trial for moderate AS patients and gained significant learnings from the Alliance pivotal trial to study the next-generation TAVR technology, SAPIEN X4. These transformative developments reinforce Edwards Lifesciences’ long-term confidence in the strong growth of transcatheter-based aortic valve interventions.
Medtronic MDT, at the same time, despite healthcare staffing challenges, is seeing great physician reception for the company’s Evolut FX system, which just completed its full quarter launch in the United States. Evolut FX combines industry-leading durability with enhanced and predictable valve deployment. In addition, data presented at PCR London Valves showed that Evolut FX’s Commissure alignment has improved significantly, which is important for coronary access and valve hemodynamics. Medtronic is currently working to seek Evolut FX’s approval in the Japanese and European markets.
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