Boston Scientific Bets $3 Billion in Third Attempt to Re-enter TAVR Market, Challenging Medtronic and Edwards’ Duopoly

May 18,Boston Scientific Announces $1.5 Billion Investment in TAVR Manufacturer MiRus, LLC

Currently,Boston Scientific holds approximately 34% of the equity in MiRus, LLC.This transaction includes an exclusive acquisition option:

• If formally acquiring MiRus, LLC's Siegel balloon-expandable TAVR valve system, additional payments will be required upon reaching predetermined performance milestones; the total could amount to $30 billion in cash.

• If the formal exercise is completed and the acquisition is finalized, MiRus may receive additional royalties based on the sales of Siegel products within a specified period.

• In addition,Boston Scientific also has an exclusive right of first refusal to acquire, with additional funding, assets related to MiRus, LLC's mitral and tricuspid valve replacement technologies.

Siegel System, currentlyIn the clinical trial stage, equipped with a low outer diameter delivery device, made of self-developed nickel-free rhenium alloy material, featuring unique physical and chemical properties; its dry porcine pericardial valve leaflets undergo anti-calcification treatment, and the valve can be pre-mounted on the balloon.

Boston Scientific stated that the valve design combines high yield strength, fatigue resistance, and a low recoil rate, with precise delivery and positioning during surgery. MiRus, LLC claimed that Siegel has set several firsts in the TAVR field: an 8Fr delivery sheath can significantly reduce surgical trauma, broaden the range of applicable patients, especially for female patients;As the world's only nickel-free transcatheter heart valve (THV) system, this product meets the clinical treatment needs of 20% of nickel-allergic patients in the United States.。

Currently, Siegel is conducting clinical evaluations for the indication of severe symptomatic aortic stenosis (AS). The mainstream aortic stenosis treatment valve products currently on the market include Edwards Lifesciences' Sapien valve and Medtronic's Evolut FX valve. Earlier this year, Medtronic invested $90 million in another balloon-expandable valve development company, Anteris Technologies, and the two parties reached a similar cooperation agreement.

This investment in MiRus and the potential acquisition of the Siegel project are expected to help Boston Scientific re-enter the TAVR market. The company discontinued its Acurate valve last year and terminated the Lotus valve project five years ago.

Dr. Jay Yadav, founder and CEO of MiRus, LLC, stated: "The SIEGEL valve holds broad clinical application prospects, with its minimally invasive delivery method, nickel-free material, precise implantation results without foreshortening deformation, and excellent hemodynamic performance, earning high recognition from clinical research physicians. Partnering with Boston Scientific, combined with the strong capabilities of our Atlanta-based R&D team, will accelerate the launch of this disruptive diagnostic and therapeutic product, benefiting doctors and patients as soon as possible."

The multi-billion-dollar transcatheter heart valve market is still undergoing continuous transformation and rapid development. With the gradual popularization of minimally invasive therapies in the field of structural heart disease diagnosis and treatment, market forecasts predict that the industry's overall sales compound annual growth rate (CAGR) will reach 8.4% over the next decade. Edwards Lifesciences, Medtronic, and Abbott are the main competitors in the current market.

BTIG Analysts Maintain Buy Rating for Boston Scientific. The analysts mentioned that Boston Scientific had previously prepaid $100 million to MiRus, LLC.This layout marks the company's third push to capture the TAVR market share.

"We believe the timing of this investment announcement is unexpected. However, at last year's investor conference, the company had already included mitral valve, tricuspid valve, and TAVR products in its R&D pipeline for 2028 and beyond. The project’s technology shows potential, but pivotal clinical trials have just begun, with FDA approval expected between late 2028 and early 2029. Commercial profitability will take many more years. Market investors may question the current timing of the investment, the project’s valuation, and its competitive strength in the mature TAVR market, which is dominated by leading giants."