Dive Brief:
- Boston Scientific said Monday it has invested $1.5 billion to acquire a 34% equity stake in MiRus, a company developing a balloon-expandable transcatheter aortic valve replacement system.
- The agreement gives Boston Scientific an exclusive option to acquire the MiRus TAVR system, subject to additional payments and the completion of certain clinical and regulatory milestones. Boston Scientific said it may opt to acquire the rest of the TAVR business for additional cash payments totaling $3 billion.
- The deal comes about a year after Boston Scientific stopped selling its Acurate Neo2 and Acurate Prime TAVR devices, which were CE-marked in Europe, and ended plans to pursue approvals in the U.S. and other locations.
Dive Insight:
Boston Scientific is making another run at the steadily growing TAVR market after cutting short two previous attempts to establish a presence. The company ended worldwide sales of the Acurate platform after Neo2 failed to demonstrate noninferiority to Edwards Lifesciences’ Sapien valve and Medtronic’s Evolut device in a head-to-head clinical trial.
In 2020, Boston Scientific also discontinued development of the Lotus Edge TAVR system due to challenges with the device delivery system.
Now, the company will resume efforts to bring a new TAVR system to market that may improve patient outcomes. Lance Bates, president of interventional cardiology and vascular therapies, said the occurrence and recognition of aortic stenosis is growing rapidly.
"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," Bates said in a statement.
The valve is the first nickel-free, balloon-expandable TAVR valve intended to restore function and normal blood flow of severely narrowed aortic valves, according to Boston Scientific. MiRus is evaluating three sizes of the device in patients with severe, symptomatic aortic stenosis who are at low, intermediate or high risk for surgical complications in the STAR pivotal trial.
If Boston Scientific exercises the option to acquire the TAVR business, MiRus will have the right to receive further payments based on net sales of the Siegel valve over a certain period. Boston Scientific will also have an exclusive option to acquire mitral and tricuspid replacement valve assets from MiRus for an additional payment.
Boston Scientific said the investment in MiRus is expected to be immaterial to adjusted earnings per share in 2026.
