In Brief: Thermo Cardiosystems HeartMate
This article was originally published in The Gray Sheet
Thermo Cardiosystems HeartMate: Left ventricular-assist system is implanted for the first time in the U.K. as a permanent alternative to heart transplant. The procedure is the first of a "series of implants in which the electric LVAS will be used to permanently take over the pumping function of natural hearts too weak to beat adequately on their own," the company says. Woburn, Massachusetts-based Thermo Cardiosystems says it is "actively working" with FDA to begin a study of the HeartMate as a "permanent alternative to other medical treatments for patients who do not qualify for transplants." HeartMate was approved by FDA in October 1994 for use as a bridge-to-heart transplant ("The Gray Sheet" Oct. 10, 1994, p. 1)...
You may also be interested in...
AMAG outlines plans for retrospective real-world evidence studies, and possibly a new placebo-controlled trial with a primary endpoint of preterm birth <32 weeks, in a filing opposing the Center for Drug Evaluation and Research’s proposal to withdraw the drug.
The leading Korean pharma firm’s oral, third-generation EGFR-TKI is approved in the country, providing a new option for patients with advanced NSCLC and increasing hopes for global approvals given an ongoing global Phase III combination trial led by partner J&J.
DePuy Synthes expects its Velys robotic-assisted system to be cost-effective, easy-to-use and to be well-suited for use in ambulatory surgery centers.