Possis receives FDA clearance for GuardDOG Occlusion System

By Lisa Kerner

Charlotte, N.C., Aug. 22 - Possis Medical, Inc. said it received 510(k) clearance from the Food and Drug Administration for its GuardDOG Occlusion System for use during the treatment of peripheral vascular disease.

The guidewire-based occlusion device helps manage local blood flow during the use of interventional techniques and devices to treat vascular disease.

"Peripheral vascular disease is a potentially limb and life threatening condition, and the GuardDOG Occlusion System provides a new option for controlling local blood flow and facilitating infusion of therapeutic or diagnostic fluids, as well as delivery of interventional devices," chief executive officer Robert G. Dutcher said in a company news release.

Possis' GuardDOG features a 0.035-inch diameter guidewire and a soft, compliant, CO2-filled balloon providing quick inflation and deflation.

In addition, the system can be inflated, deflated and positioned up to three times during a single procedure, the company said.

Possis believes the GuardDOG device will also enhance the effectiveness of its AngioJet Rheolytic Thrombectomy System and PowerPulse lytic drug delivery therapy in the removal of tough peripheral thrombus, officials said.

The company plans full U.S. market release of the GuardDOG by the end of the year, with 510(k) clearance of a 0.014-inch version expected in fiscal 2007.

Possis develops, manufactures and markets medical devices for the cardiovascular and vascular treatment markets.

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