Boston Scientific Invests $1.5B for 34% Stake in MiRus

Boston Scientific has invested $1.5 billion for an about 34% equity stake in MiRus, a private company developing and commercializing biomaterials, implants, and procedural solutions to treat cardiovascular and orthopedic diseases, including the Siegel balloon expandable transcatheter aortic valve replacement (TAVR) system.

As part of the investment agreement, Boston Scientific received an exclusive option to acquire the MiRus TAVR system. The Siegel technology is built on a proprietary rhenium alloy and is marketed as the first nickel-free, balloon-expandable TAVR valve intended to restore function and normal blood flow of severely narrowed aortic valves.

The Siegel valve was designed with leaflets made of dry porcine tissue and a nitric oxide-coated rhenium frame, which has a greater radial strength than cobalt or titanium. The open cell design is intended to remove foreshortening and aid precise placement in the heart.

The valve is also pre-mounted directly onto the balloon and all sizes can be delivered through an 8 Fre expandable sheath. The sheath is about 50% smaller than current commercially available TAVR delivery sheaths and may minimize vascular injuries.

“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 began the STAR pivotal trial evaluating the safety and effectiveness of the three sizes of the Siegel valve in up to 1,025 patients with severe, symptomatic aortic stenosis at low, intermediate or high risk for surgical complications.

Last year, the company presented findings from an early feasibility study evaluating the device’s safety and performance.

“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, MD, founder and CEO of 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.”