Arrow predicts Euro approval date for LionHeart:
This article was originally published in Clinica
Arrow International says that it is on track to gaining European market approval in June 2002 for its fully implantable cardiac assist device. The LionHeart left ventricular assist system, which is designed to provide patients with "destination therapy", was recently implanted in two patients in Germany, bringing the total number of European implants to 25. The Reading, Pennsylvania firm is also pressing on with a phase I trial of the device in the US. Seven LionHearts have been implanted in the US and the FDA has approved an additional seven implants as a continuation of the study, the firm said.
You may also be interested in...
The first trial of the new Flash ultra-high dose radiation therapy with Varian Medical Systems’ ProBeam particle accelerator has begun. Agum Sharda, Varian’s senior director of Flash, says the technology could be a major advance for cancer patients.
The European public assessment report for Kaftrio shows that EU regulators had concerns about whether Vertex’s triple drug combination for cystic fibrosis represented a new treatment paradigm.
Swissmedic says its good manufacturing practice certificates remain valid for longer than companies might assume. Separately, it is giving companies more time to conduct nitrosamine-related risk evaluations.