Japan approves Datascope's balloon pump and catheter:
This article was originally published in Clinica
Executive Summary
Datascope has received the go-ahead to market its System 98 intra-aortic balloon pump and Profile 8 French catheter in Japan. The catheter allows the surgeon to carry out both coronary angioplasty and balloon pumping using the same sheath. By eliminating the need to exchange sheaths, possible vascular complications are reduced and balloon pumping is simpler and more convenient, according to the Montvale, New Jersey-based company. The system has already received US FDA approval and is CE-marked.