Boston Scientific announces strategic investment in MiRus LLC
Agreement includes exclusive option to acquire novel, balloon-expandable transcatheter aortic valve made with proprietary rhenium alloy
"The occurrence and recognition of aortic stenosis is growing rapidly and our investment in MiRus continues our pursuit to bring a differentiated TAVR system into our portfolio that we anticipate may improve outcomes for patients living with this life-threatening disease," said
The SIEGEL TAVR valve is designed with leaflets made of dry porcine tissue and a nitric oxide-coated rhenium frame, which has a radial strength greater than cobalt or titanium.1 The open cell design of the frame is intended to eliminate foreshortening and aide precise placement in the heart. Uniquely, the valve is also pre-mounted directly onto the balloon and all sizes – 23 mm, 26 mm and 29 mm – can be precisely delivered through an 8 French expandable sheath, which is approximately 50% smaller2 than current commercially available TAVR delivery sheaths and may minimize vascular injuries.
MiRus recently initiated the STAR pivotal trial that is evaluating the safety and effectiveness of the three sizes of the SIEGEL valve in up to 1,025 patients with severe, symptomatic aortic stenosis considered to be at low, intermediate or high risk for surgical complications. Last year, MiRus presented findings from an early feasibility study assessing the safety and performance of the device.
"The SIEGEL valve is a promising technology and has received enthusiastic feedback from physician investigators for its less invasive delivery, nickel-free construct, precise placement resulting from a lack of foreshortening and excellent hemodynamics," said
The investment in MiRus is expected to be immaterial to adjusted earnings per share for Boston Scientific in 2026. Boston Scientific may exercise the option to acquire the MiRus TAVR business by making additional aggregate cash payments totaling
Caution: The SIEGEL™ Balloon Expandable Transcatheter Aortic Valve Replacement (TAVR) system is an investigational device, which is not yet approved for commercial distribution in any country.
1 Per ASTM standards specification
2 Edwards eSheath+ Introducer Set Instructions for Use (2023-08 10058349001 A)
About Boston Scientific
Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding the financial and business impact of the investment and the anticipated benefits of the investment, the exercise of the option and the timing thereof, business plans and strategy, clinical trials, product approvals and product performance and impact. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the forward-looking statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.
Factors that may cause such differences include, among other things: economic conditions, including the impact of foreign currency fluctuations; future
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SOURCE Boston Scientific Corporation
