Arrow predicts Euro approval date for LionHeart:
This article was originally published in Clinica
Executive Summary
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...
US FDA Drugs Center Ready To Break Down Silos On Regulatory Innovation
CDER Director Cavazzoni is promising to increase coordination and collaboration to accelerate broader adoption of innovative clinical trial designs and other approaches to speed drug development. A new "Quantitative Medicine Center of Excellence" illustrates the approach.
New OSP Director To Guide CDER-Wide IT Upgrades; System Enhancements Speed ANDA Assessments
Generic Drug Structured Assessment for Bioequivalence launched in 2023 and has been used in 40 ANDA reviews so far.
New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add two new products, including Ryzneuta, Evive Biotechnology's treatment for chemotherapy-induced neutropenia.