SOURCE: Datascope Corp.

July 06, 2005 17:49 ET

Datascope Announces Launch of ProGuide™ Chronic Dialysis Catheter

MONTVALE, NJ -- (MARKET WIRE) -- July 6, 2005 -- Datascope Corp. (NASDAQ: DSCP) announced the launch of ProGuide™, a new chronic dialysis catheter. The company previously announced receipt of FDA 510k clearance to market ProGuide in the U.S.

Chronic dialysis catheters connect a patient with end-stage renal disease to a dialysis machine. In the U.S., over 300,000 people annually require hemodialysis to compensate for lost kidney function. Chronic dialysis catheters provide needle-free access to the central venous system for the dialysis procedure, and have an estimated worldwide market of more than $100 million.

ProGuide is the first dialysis catheter designed specifically for an over-the-wire insertion. Hemodialysis catheters commonly use a thin-walled tube or "sheath" to gain entry to the central venous system. By eliminating the peel-away sheath, ProGuide allows for an easy over-the-wire insertion and has been documented as being more convenient than other dialysis catheters on the market.

In a 25-patient observational study using the ProGuide catheter, Dr. Jeffrey Siegel, Director of Radiology and Interventional Radiology at Dallas Nephrology Associates, writes, "The ProGuide is easily placed in multiple access sites. The ability to place the catheter over a guide wire and without a peel-away sheath makes the procedure more convenient and somewhat faster than standard catheter placement methods. The catheters were easy to see fluoroscopically and easy to position. Catheter patency and flow has been excellent thus far."

Additionally, the elimination of the sheath provides an important clinical benefit for the patient. The sheath provides a path for insertion of the catheter, but also makes it possible for air to enter the bloodstream, a dire complication occurring in approximately 1% of cases. During the sheathless insertion of ProGuide, moist skin and tissue surrounding the catheter effectively seal against the passage of air, thereby reducing the opportunity for air to enter the vein and thus the possibility of air embolism.

ProGuide is one of four new products that were shown by Datascope at the Society of Interventional Radiology (SIR) meeting in New Orleans in April 2005, emphasizing the company's growing activity to this field. In addition to dialysis access products, IPD currently sells a range of vascular closure devices for the interventional cardiology and interventional radiology markets.

Datascope Corp. is a diversified medical device company that manufactures and markets proprietary products for clinical health care markets in interventional cardiology and radiology, cardiovascular and vascular surgery, anesthesiology, emergency medicine and critical care. Datascope's news releases and other company information can be found on the company's website, http://www.datascope.com.

Contact Information

  • For Information Contact:
    Rachel Winokur
    Corporate Director, Business Development
    Datascope Corp.
    14 Philips Parkway
    Montvale, NJ 07645
    (201) 307-5429
    www.datascope.com