Baxter Enrolls First Patient in U.S. Clinical Trial for VIVIA Investigational Home Hemodialysis System

 

Baxter International Inc announced enrollment of the first patient in a U.S. clinical trial for VIVIA, an investigational home hemodialysis (HD) system being developed by Baxter and DEKA Research & Development Corporation.

The trial is designed to study more frequent, extended duration nocturnal home HD therapy (High Dose HD), which will be performed in dialysis facilities as well as the home setting. The study is assessing safety of the product and adequacy of dialysis.

The VIVIA investigational home hemodialysis system includes an integrated water purification module, safety sensors and one-button fluid infusion. The investigational system also features SHARESOURCE, Baxter’s two-way connectivity platform that allows physicians and nurses to monitor patients’ historical treatment results remotely.

FDA Approves of Cefazolin 2 Gram Premix

Baxter International Inc. and Water Street Healthcare Partners announced the United States Food and Drug Administration (FDA) has approved CEFAZOLIN Injection in GALAXY Container (2 g/100 mL), which is Baxter’s flexible container that uses the company’s proprietary aseptic filling manufacturing processes. CEFAZOLIN injection is a cephalosporin antibacterial indicated for preoperative prophylaxis treatment. When used for preoperative prevention, it may reduce the incidence of certain postoperative infections for high-risk patients undergoing surgical procedures. See below for full Indication and Important Risk Information.

CEFAZOLIN injection has been on the FDA’s drug shortage list for more than one year due to high demand. Baxter anticipates launching CEFAZOLIN injection 2 gram frozen premix in its GALAXY container in the United States in the fourth quarter of 2015.

CEFAZOLIN injection 2 gram represents the first of nine molecules actively under development to provide healthcare providers needed injectable formulations of essential drugs frequently used in critical care settings through Baxter’s development partnership with Celerity Pharmaceuticals, LLC, a company of Water Street, a strategic investor focused exclusively on the healthcare industry.