Hemo-Stream Chronic Dialysis Catheter Receives FDA Clearance
Hemo-Stream Chronic Dialysis Catheter
FDA has given clearance to Angiotech Pharmaceuticals to begin marketing the Hemo-Stream chronic dialysis catheter.
The Hemo-Stream catheter, developed by Rex Medical, LP, is the first chronic hemodialysis catheter specifically designed for over-the-wire delivery. Its advantages include higher flow rates due to its triple lumen design, reduced potential for air embolism or bleeding, decreased procedural steps and time versus competition, and ease of catheter placement. Dialysis catheters, such as Hemo-Stream, are used for short term vascular access to provide hemodialysis patients with the dialysis they require.
In April 2007, Angiotech entered into an agreement with Rex Medical whereby Rex Medical granted Angiotech an exclusive license to market and distribute the Hemo-Stream catheter worldwide.
"The Hemo-Stream catheter is a great complement to the vascular graft business we acquired from Edwards and our Vascular Wrap AV access trials which are currently enrolling," said Dr. William Hunter, President and CEO of Angiotech. "With over 500,000 End Stage Renal Disease patients in the U.S., Angiotech is focused on the development and commercialization of innovative dialysis care products that improve the treatment options available to hemodialysis patients and vascular surgeons."
It is expected that Hemo-Stream catheters will be available for commercial sale in the U.S. later this year.