Medtronic plc received CE mark approval for its Harmony transcatheter pulmonary valve system to treat congenital heart disease patients with native or surgically repaired right ventricular outflow tract pulmonary regurgitation.
Edwards Lifesciences Corp. said it has exercised its option to buy Innovalve Bio Medical Ltd., an early stage transcatheter mitral valve replacemen company, for $300 million in cash following its initial investment in 2017. Since that time, Edwards said Innovalve has demonstrated progress in its program with promising early clinical experience.
Canary Medical Inc. is seeking patent protection for devices, systems, and methods for in vivo monitoring of the flow of a biological fluid in an anatomic structure.
Affluent Medical SA reported initial success from the first minimally invasive transcatheter implantation of its biomimetic Epygon heart valve. This was placed in a 62-year-old female suffering from a severe form of mitral regurgitation, considered untreatable via traditional heart surgery due to multiple risk factors. This first-in-human trial was performed at the Molinette Hospital, part of the City of Turin University Hospitals of Health and Science.
The U.S. FDA announced Feb. 27 that it is aware of data that suggest that the Trifecta surgical aortic valve replacement (SAVR) devices are potentially prone to early structural deterioration that could compromise both valve performance and valve durability.
The patent wars over the design of transcatheter aortic valve replacement (TAVR) devices seemed to disappear roughly nine years ago, but there is at least one more episode for Dublin-based Medtronic plc before the company could lay the issue to rest. A jury declared that Medtronic is liable for more than $100 million in damages over alleged infringement of a patent held by Broomfield, Colo.-based Colibri Heart Valve LLC, but the contested patent has expired, and Medtronic said it intends to pursue the matter further.
