Cardiogenesis trials
This article was originally published in The Gray Sheet
Executive Summary
Foothill Ranch, Calif.-based company submits IDE application to FDA to conduct trials supporting angina treatment indication for percutaneous myocardial channeling (PMC) system, the firm announces July 6. Cardiogenesis secured an agreement from FDA in June on key aspects of the trial design, endpoints and patient criteria for the study protocol. The company plans to leverage data from an Axcis PMC device rejected by FDA in 2001 (1"The Gray Sheet" Nov. 22, 2004, p. 14)...
You may also be interested in...
Percutaneous Myocardial Laser Developer Drafts IDE Agreement With FDA
CardioGenesis will meet with FDA by year-end to finalize a clinical trial protocol to support PMA approval of its Axcis laser percutaneous myocardial channeling (PMC) system for treating severe angina
Deal Watch: AbbVie Teams With MedinCell On Long-Acting Injectables
Collaboration Edition: Including deals involving Evotec/Variant, Sanofi/IGM/Nurix, ABVC/OncoX and Harmony/Bioprojet, along with tech transfer agreements and deals in brief.
GE HealthCare Launches AI-Powered Voluson Ultrasound For Women’s Health
Voluson Signature 20 and 18 ultrasound provides clinicians with workflow efficiencies in detecting female reproductive health problems, especially those related to pregnancy.