ACIST Medical Systems Receives FDA Clearance for Voyager Model E2000 Contrast Delivery System.

Health/Medical Writers

EDEN PRAIRIE, Minn.--(BW HealthWire)--March 13, 2001

Acist(R) Medical Systems announced today that it has received Food and Drug Administration (FDA) clearance for the Voyager(TM) Model E2000 Contrast Delivery System. The Voyager System is designed to be used in conjunction with x-ray equipment to diagnose and treat vascular disease.

The Voyager System is being launched in early April in the U.S. endovascular market. The new system was showcased recently at the 26th Annual Scientific Meeting of the Society of Cardiovascular and Interventional Radiology (SCVIR), March 3-8 in San Antonio, TX.

The Voyager System can be used in interventional radiological procedures, such as balloon angioplasty (used to open up blocked blood vessels) and endovascular surgical procedures, such as repair of abdominal aortic aneurysms (bulges that weaken the wall of an artery). Unlike traditional surgery, these types of procedures allow physicians to diagnose and perform life-saving operations using catheters inserted through small incisions. This can be more effective, safer, and less expensive than standard surgery, with less trauma and easier recovery for patients.

These procedures use angiography, in which the physician injects a type of dye called contrast solution into the patient's bloodstream. When used with x-ray equipment, the contrast solution outlines the patient's arteries or veins on a monitor screen--which allows the physician to locate the vessel in question and determine treatment.

After a procedure, the contrast dye is gradually eliminated from the patient's kidneys. Because patients suffering from vascular disease often have accompanying poor kidney function, their bodies must work harder to excrete contrast. The Voyager System is the only injection system of its kind that allows the physician instant and variable control over the amount and flow of contrast. This control enables the physician to keep the amount of injected contrast to a minimum, helping to alleviate stress on the kidneys.

Historically, physicians have performed angiography using a combination of hand syringes and a large, motorized injector which often requires reconnecting to equipment that comes from outside of the sterile field. The Voyager System, however, provides the physician with one integrated system that handles a variety of injections and remains connected and within the sterile field during the entire diagnostic and/or interventional procedure. The Voyager System includes an automated syringe operated by the AngioTouch(R) hand controller (a button-operated device), and a touchscreen display, which the physician can use to tailor injections for any special needs while remaining at the patient's side.

In addition, the Voyager System is designed to reduce the amount of contrast media which is wasted at the end of the procedure. Contrast remaining within the bottle and within the syringe is typically disposed of at the end of the case. The Voyager System employs technology that allows this contrast to be safely used on up to five patients.

"The Voyager System, which is built on our proven CMS technology platform, is a natural fit for interventional radiology and endovascular procedures," said Dan Gladney, Acist President and CEO. "It allows the physician to focus on the patient and the procedure, rather than on the manipulation of various stopcocks and syringes on a patient manifold."

"Innovation in contrast delivery has lagged behind that of more advanced and smaller medical devices such as balloon catheters and stents," said Gladney. "The Voyager System joins that innovation by providing a single system for physicians to use from diagnosis through intervention and for hospitals who are looking to improve their costs on a per procedure basis."

Acist Medical Systems, headquartered in Eden Prairie, MN, is a privately held corporation founded in 1991 that has developed a unique and semi-automated system to improve the delivery of contrast agents during angiography procedures. Acist's other products, the CL100H and the CMS2000--used in cardiology procedures--have been sold in the U.S. since 1998 through Bracco Device Division, an exclusive U.S. distributor in cardiology, and worldwide since 2000, through a network of distributors. The company is dedicated to delivering quality medical products that meet a clinical need and which will continue to offer clinicians a novel approach to improving the lives of their patients.