Boston Scientific is reminding European healthcare providers that a company field clinical specialist must be present during procedures involving the Lotus Valve System unless the establishment has been classified as independent.
The company issued this reminder in the form of a letter that is posted on Germany’s Federal Institute for Drugs and Medical Devices’ website. The Lotus valve is used for transcatheter aortic valve implantation and is not available in the U.S.
To be deemed independent, a facility must have two doctors who have received live classroom training. These physicians must have participated in two procedures involving the device in the presence of a training physician and a Boston Scientific field clinical specialist. Further, they must perform an additional four procedures in the presence of a field clinical specialist.
The company emphasizes that the product is not being recalled and there is no effect on already implanted devices. That said, the company did advise that part of the system could be damaged during the preparation phase prior to the procedure, but the problem may not be visible.
Physicians may remove a damaged device; however, a longer procedure time will result.
To help avoid damage during the preparation phase, the company is advising that catheter lab staff receive training from a field clinical specialist.
Separately, Boston Scientific has filed a lawsuit in the U.S. District Court for the District of Delaware against Edward Lifesciences, alleging infringement of the ’608 patent related to adaptive sealing technology, a key feature of Lotus.
It alleges that the sale of Edwards’ Sapien 3 transcatheter heart valve constitutes willful infringement.
It filed Boston Scientific Corporation and Boston Scientific Scimed, Inc., v. Edwards Lifesciences Corporation April 19.
The devicemaker filed a separate suit against Edwards in the U.S. District Court for the Central District of California the same day, alleging infringement of a number of patents.
Last October, a Boston Scientific unit filed suit in the Düsseldorf District Court in Germany against Edwards that also alleged the SAPIEN 3 infringes the company’s patent related to adaptive sealing technology. ― Elizabeth Hollis