Boston Scientific (NYSE:BSX) has officially hit the German market with the 1st commercial patients treated this month, just weeks after the company won CE Mark approval to sell the product in the European Union.
The news marks Boston Scientific’s arrival in the ongoing TAVI war between industry giants Medtronic (NYSE:MDT) and Edwards Lifesciences (NYSE:EW), which have for years been duking it out on the highly coveted German market.
Boston Scientific’s Lotus is a next-generation TAVI system designed to address some of the issues learned from earlier technologies. The device provides physicians procedural control and features proprietary Adaptive Seal technology that helps prevent leakage, a major issue with earlier valves. Lotus can also be repositioned, retrieved and redeployed prior to final release of the device inside the heart.
The Massachusetts company certainly has its work cut out for it in taking some share in the German market, where its TAVI rivals have been making waves.
Medtronic just this month regained legal rights to sell its CoreValve TAVI system in Germany when a European patent decision reversed a ban. In July the court ruled that Medtronic’s CoreValve TAVI infringes Edwards Lifesciences’ Spenser patent, forcing it to cede the German market to Edwards and its Sapien valve. But last month the European Patent Office issued a preliminary, non-binding ruling that the Edwards patent at the center of the dispute in Germany is invalid.
The German market is a very attractive one for TAVI makers, with an estimated half of all elderly patients in Germany in line to get the implants. German doctors have adopted TAVI faster than any other country, according to research released during last year’s European Society of Cardiology Congress.