Balloon Aortic Valvuloplasty Market Report By Insights, Size, and Growth - 2031

The balloon aortic valvuloplasty market is anticipated to increase from US$ 125.08 million in 2023 to US$ 190.27 million by 2031, reflecting a compound annual growth rate (CAGR) of 5.4% during the period from 2023 to 2031.

The growing incidence of aortic valve stenosis, coupled with a rising preference for minimally invasive surgical options, are significant factors driving the growth of the balloon aortic valvuloplasty market. Nevertheless, the high costs associated with these procedures pose a challenge to market expansion.

Initially, transcatheter aortic valve replacement (TAVR) was reserved for patients with severe aortic stenosis who were deemed inoperable or at extremely high risk. However, advancements in valve technology and the outcomes of randomized clinical trials have broadened its application to include younger and lower-risk patients, establishing it as a standard treatment for aortic valve disorders. Innovations in valve manufacturing have led to an increased acceptance of bioprosthetic heart valves, particularly among younger and lower-risk demographics. Given its minimally invasive nature, TAVR is expected to become the predominant method for valve replacements. The latest generation of transcatheter heart valves has significantly enhanced procedural effectiveness, safety, and patient outcomes, making TAVR an attractive choice across various patient risk categories.

Accurately predicting the performance of heart valves upon implantation is crucial for successful TAVR procedures. It is essential to conduct mechanical assessments of selected heart valves prior to implantation to ensure optimal valve function and minimize post-implantation complications. A promising approach to facilitate the mechanical evaluation of heart valves is the integration of deep learning (DL) systems, which can streamline and enhance computational biomechanical analyses pertinent to TAVR. Recent advancements in DL methodologies have resulted in exceptional performance in numerous computer vision applications, such as image classification, segmentation, and object detection. DL has been extensively explored for various cardiac imaging tasks, including diagnostics, prognostics, risk assessment, and planning for therapeutic or surgical interventions. Numerous studies have focused on DL techniques for evaluating TAVR outcomes, aiming to predict postoperative complications and prosthetic valve failures.

Ongoing research and development efforts suggest a bright future for TAVR, reinforcing its role as a revolutionary treatment in cardiovascular care. Currently, the FDA has approved only the Edwards SAPIEN 3 Ultra, Medtronic EVOLUT FX, and Abbott Navitor valves. While most clinical experience with TAVR is associated with the Edwards and Medtronic systems, the landscape of transcatheter heart valves is expanding, with five to ten new TAVR valves currently under development. The outlook for TAVR is promising, with increasing indications, rising procedural volumes, and a growing number of clinical sites offering the procedure, although concerns regarding long-term durability persist. The leaflets of the available valves are primarily made from porcine or bovine pericardial tissue. New valve designs incorporating innovative leaflet materials and other enhancements are being developed to improve long-term durability. Some upcoming trials are expected to provide essential insights for TAVR practitioners aiming to deliver long-lasting solutions. The SMART (SMall Annuli Randomized to Evolut or SAPIEN) trial represents the first randomized, industry-sponsored (by Medtronic) head-to-head comparison of the two most widely used TAVR devices: SAPIEN 3 and Evolut, specifically in patients with small anatomies. Conducted across 83 international sites in North America, Europe, and the Middle East & Africa, the trial enrolled 716 participants with a small aortic annulus (defined as an aortic annulus area of 430 mm2 or less based on multi-detector computed tomography) and symptomatic severe native aortic stenosis. In April 2024, the American College of Cardiology announced that findings from the SMART trial indicated that patients with a small aortic annulus who underwent TAVR with the Evolut valve experienced comparable clinical outcomes and superior valve performance at one year compared to those who received the SAPIEN 3 valve. Researchers expressed optimism regarding the clinical outcomes associated with both valve types and will continue to monitor results over the next five years. Consequently, ongoing research and development aimed at enhancing TAVI procedures are likely to introduce new trends within the balloon aortic valvuloplasty market.

Insights Based on Product Type

The balloon aortic valvuloplasty market is categorized by product type into non-compliant balloons and semi-compliant balloons. In 2023, the non-compliant balloons segment captured a larger share of the balloon aortic valvuloplasty market and is projected to exhibit a higher CAGR during the period from 2023 to 2031.

The National Echo Database of Australia and the Institute of Health Economics are among the key primary and secondary sources utilized in the preparation of the balloon aortic valvuloplasty market report.