Healthcare Industry News:  vascular access 

Devices FDA

 News Release - December 7, 2009

r4 Vascular Receives FDA 510(k) Clearance to Market the First Power-Injectable Apheresis Catheter

MAPLE GROVE, Minnesota, December 7, 2009 - (HSMN NewsFeed) - r4 Vascular, a Minnesota-based medical device company best known for its Pegasus(TM), Zeus(TM), and DrainEx(TM) catheter brands, has announced the FDA’s clearance of its power-injectable PherociousTM Apheresis Catheter. It is the first apheresis catheter that, in addition to apheresis, intravenous infusions, and blood sampling, is indicated for power injection of contrast media for contrast enhanced computed tomography (CECT) imaging. The catheter will be available in both 12.5F and 10.5F sizes.

According to r4 Vascular’s VP Sales, Ehab Ali, “The added functionality of our Pherocious catheter will reduce the number of needlesticks apheresis patients currently require for CT studies.” He goes on to say, “There have been few innovations in vascular access for apheresis patients, and r4 is proud to be able to help these patients with our new triple lumen catheter.”

According to Patricia Golden, RN, and Hemapheresis Practitioner (ASCP), “More than a quarter of a million patients undergo apheresis each year for the treatment of neurological, immunologic, hematologic or oncologic disorders; and for stem cell transplantation.”

r4 Vascular is a privately-held vascular access company driving innovation in vascular access medical technology. r4's passion is “uncomplicating” venous access, chemotherapy, and drug delivery, through product improvements that help catheters remain patent and effective, with reduced risk of complications. The Pherocious apheresis catheter is the 4th new catheter launched by r4 Vascular this year.


Source: r4 Vascular

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