Boston Scientific Invests $1.5 Billion in MiRus With Option to Buy Its TAVR Business

Boston Scientific has invested $1.5 billion in MiRus in return for an approximately 34% equity stake, along with an exclusive option to acquire the company's transcatheter aortic valve replacement (TAVR) business, the device maker said on May 18.

Boston Scientific may exercise the option by making additional cash payments totaling $3 billion after MiRus achieves certain clinical and regulatory milestones, which would give it 100% ownership of the TAVR business, subject to customary closing conditions. If it does, MiRus will also receive payments based on net sales of the SIEGEL TAVR valve over a specified period, and Boston Scientific will gain an exclusive option to buy MiRus's mitral and tricuspid replacement valve assets for a further payment.

The company said the investment is expected to be immaterial to its adjusted earnings per share in 2026.

The SIEGEL valve

MiRus is a privately held company developing biomaterials, implants and procedural tools for cardiovascular and orthopedic diseases. Its SIEGEL valve is built on a proprietary rhenium alloy, and Boston Scientific described it as the first nickel-free, balloon-expandable TAVR valve.

The valve uses leaflets of dry porcine tissue on a nitric oxide-coated rhenium frame and comes pre-mounted on the delivery balloon. All three sizes, 23 mm, 26 mm and 29 mm, are delivered through an 8 French expandable sheath, which Boston Scientific said is about 50% smaller than current commercially available TAVR delivery sheaths. The SIEGEL system is an investigational device that is not approved for commercial distribution in any country.

MiRus recently started the STAR pivotal trial, which is evaluating the three valve sizes in up to 1,025 patients with severe, symptomatic aortic stenosis at low, intermediate or high surgical risk. MiRus presented findings from an early feasibility study last year.

"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," said Lance Bates, president of Interventional Cardiology and Vascular Therapies at Boston Scientific.

Jay Yadav, MiRus's founder and CEO, said the 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."

A third attempt at TAVR

The deal is Boston Scientific's latest attempt to build a presence in TAVR, MedTech Dive reported. It comes about a year after the company stopped selling its Acurate Neo2 and Acurate Prime valves, which were CE-marked in Europe, and dropped plans to seek approvals in the US and elsewhere.

MedTech Dive said Boston Scientific ended worldwide Acurate sales after Neo2 failed to show noninferiority to Edwards Lifesciences' Sapien valve and Medtronic's Evolut device in a head-to-head trial. In 2020, the company also discontinued development of its Lotus Edge TAVR system because of problems with the delivery system, the publication reported.