具体情况不了解，根据网上搜索的结果，

这套设备可能（注意是可能）还没有最后通过FDA批准？

Both the MegaVac and ThromboWire devices have received FDA clearance for thrombectomy and temporary occlusion of blood flow. Much of the regulatory risk has already been mitigated and this clearance will be used to commercialize the device quickly. Capture will obtain an additional 510(k) to build on the initial clearance. The technology features a strong patent portfolio, with 10 existing patents (freedom to operate) and 3 patent applications.

来源：

http://www.capturevascular.com/wp-content/uploads/2014/04/Capture-2-Pg-Executive-Summary-v2.pdf

所有跟帖： 

• 希望是个突破 -dudaan- ♂ (0 bytes) () 10/07/2016 postreply 07:44:10