HeartWare files for destination therapy IDE
HeartWare International Inc. took another step in its chase after one-time suitor and main competitor Thoratec Corp. filing for an investigational device exemption from the Food & Drug Administration for clearance to use its miniature heart pump in patients with end-stage heart failure who aren’t eligible for a heart transplant. The Framingham, Mass.-based device maker’s left ventricular assist device is already cleared for use as a bridge to heart transplant.
For the full story, click here
-
Thoratec HeartMate II gets FDA nod
FDA gives unconditional IDE approval to Berlin Heart’s EXCOR
FDA Approves For Permanent Treatment Of Advanced Heart Failure Assist Device Pioneered By Texas Heart Institute At St. Luke’s Episcopal Hospital
Sunshine Heart C-Pulse implantable heart assist device passes 5-year durability testing
FDA nod to Lumen’s LBI Embolectomy System
