AORTIC STENOSIS MARKET ANALYSIS

Market News

New product launches/approval:

• In January 2023, Abbott, which discovers, develops, manufactures, and sells a broad and diversified line of health care products and services., announced that the U.S. Food and Drug Administration (FDA) had 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.
• In September 2022, Medtronic, which develops therapeutic and diagnostic medical products, announced the expanded U.S. market release of its newest-generation, self-expanding transcatheter aortic valve replacement (TAVR) system, the Evolut FX TAVR system. Evolut FX adds new features to the existing Evolut platform to enhance ease-of-use and predictable valve deployment for physicians.
• In September 2020, Boston Scientific Corporation, which develops, manufactures, and markets medical devices for use in various interventional medical specialties globally, announced that it had initiated a controlled launch of the ACURATE neo2 Aortic Valve System in Europe. This next-generation transcatheter aortic valve implantation (TAVI) technology is a new platform designed with a number of features to improve upon the clinical performance of the original ACURATE neo platform. Compared to the previous generation device, the ACURATE neo2 valve system also has an expanded indication for patients with aortic stenosis – with no specified age or risk level – who are considered appropriate candidates for the therapy by their heart team, including a cardiac surgeon.

Increasing Research and Development Activities:

•  On October 25, 2023, egnite, Inc., a leading cardiovascular digital health company, announced that novel research on aortic stenosis (AS) was presented by cardiologist Philippe Généreux, MD, Director of the Structural Heart Program of Morristown’s Gagnon Cardiovascular Institute, at the Transcatheter Cardiovascular Therapeutics (TCT) conference held in October 2023 at San Francisco, U.S.
• In December 2021, Aurora St. Luke’s Medical Center in Milwaukee joined a clinical trial studying a new potential replacement heart valve, continuing its long history of research into minimally invasive heart valve replacements. The study will evaluate the safety and effectiveness of Boston Scientific Corporation’s ACURATE neo2 Aortic Valve System in patients with severe symptomatic aortic stenosis who are candidates for transcatheter aortic valve replacement (TAVR).