Boston Scientific announced a $1.5 billion investment to acquire an approximately 34% equity stake in MiRus LLC, a privately held company focused on biomaterials, implants, and procedural solutions for cardiovascular and orthopedic diseases.
The agreement also gives Boston Scientific an exclusive option to acquire the MiRus TAVR business, including the investigational SIEGEL™ Balloon Expandable Transcatheter Aortic Valve Replacement system, subject to additional payments and milestone achievements.
The SIEGEL valve is the first nickel-free, balloon-expandable TAVR valve built using a proprietary nitric oxide-coated rhenium alloy. The device is designed to improve treatment for severe aortic stenosis through precise placement, reduced foreshortening, and a smaller delivery sheath intended to minimize vascular injuries.
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Lance Bates said the investment supports the company’s strategy to expand its structural heart portfolio with differentiated TAVR technology that could improve patient outcomes.
“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 Lance Bates, executive vice president and president, Interventional Cardiology and Vascular Therapies, Boston Scientific. “Built upon years of research and proprietary technology, we believe the distinctive design and impressive early clinical results of the SIEGEL valve may set it apart from currently available technology, potentially providing physicians an advanced option to treat a wide array of patients.”
MiRus recently launched the STAR pivotal trial evaluating the safety and effectiveness of the SIEGEL valve in up to 1,025 patients with severe symptomatic aortic stenosis across varying surgical risk groups.
Jay Yadav said the collaboration with Boston Scientific is expected to accelerate development and future accessibility of the technology for physicians and patients.
Under the agreement, Boston Scientific may acquire full ownership of the MiRus TAVR business through additional cash payments totaling $3 billion upon the achievement of specified clinical and regulatory milestones. The SIEGEL TAVR system remains an investigational device and has not yet received commercial approval in any country.
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“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 Jay Yadav, M.D., founder and chief executive officer, MiRus. “This collaborative relationship with Boston Scientific alongside the exceptional capabilities of our Atlanta-based team can further accelerate our progress towards broad accessibility for patients and physicians for what we believe will be a transformational treatment.”
