Biotronik starts US trials for dual-chamber ICD (implantable cardioverter defibrillator):
This article was originally published in Clinica
Executive Summary
Biotronik has begun clinical trials in the US of its Phylax AV dual-chamber implantable cardioverter defibrillator. A total of 15 sites will take part in the study and the device was implanted in the first group of patients earlier this month. The Phylax AV uses Smart detection technology to discriminate activity in the atria and ventricles and to provide the appropriate treatment. The Lake Oswega, Oregon-based company,i which has already CE-marked the product, plans to submit the data from these trials for FDA approval later this year.
You may also be interested in...
Cullinan Changes Tracks, Moving Lymphoma Bispecific Into Autoimmune
The company will discontinue its trial of the CD19-directed bispecific CLN-978 in NHL and develop it in inflammatory diseases, where it could have an edge over CAR-Ts.
Interview: Theradaptive To Enter Clinical Trial For Spinal Fusion Gel
Theradaptive, which makes a device-biologic combination product to help speed bone healing, recently got authorization to start human trials from the US FDA. Medtech Insight spoke to CEO Luis Alvarez about the company’s past, present and future.
US FDA Expects Joint AdComm Briefing Document, Oncology Chief Says
The combined format is the new default for briefing advisory committee members, US FDA Oncology Center of Excellence Director Pazdur declared.