Thoratec’s HeartMate II goes to panel
This article was originally published in The Gray Sheet
Executive Summary
FDA Circulatory System Devices advisory panel review of Thoratec's PMA for its second-generation left-ventricular assist device is tentatively set for Nov. 30, the company announces Aug. 15. The company is seeking a bridge-to-transplant indication for the HeartMate II continuous-flow LVAD based on data from a study of 279 patients, including 194 who have reached the 180-day pivotal endpoint (1"The Gray Sheet" Aug. 6, 2007, In Brief). The company also has enrolled 377 patients in a HeartMate II trial for destination therapy...
You may also be interested in...
HeartMate II PMA
Thoratec amends PMA filing for its HeartMate II left-ventricular assist device as a bridge to cardiac transplant in response to an FDA letter outlining deficiencies, the firm announces July 31. The amended filing includes new data from 279 patients, including 194 patients who have reached the 180-day pivotal study endpoint. The original PMA, filed last winter, included data from 133 patients. Following a May meeting with FDA, Thoratec revised its expectation for approval to late 2007 or early 2008 (1"The Gray Sheet" May 7, 2007, p. 13). The company also has enrolled 377 patients in a trial intended to establish HeartMate II as a "destination therapy"...
Beauty Firms Using AI-Based Tools Could Be Subject To Health Privacy Laws In US States
Using AI-based programs to collect and store consumer information risks running afoul of new health privacy laws cropping up in US states. Lack of federal regulation or guidance on the issue is one of the biggest challenges for beauty firms deploying AI, according to Stacy Marcus, partner at Reed Smith LLP.
Mustang Bio Enters Race For CAR-T In Autoimmune Disease
The biotech company’s CEO talked to Scrip about plans to bring the CD20-targeting CAR-T MB-106 into an investigator-sponsored Phase I trial later this year.