Medical Device Daily

Possis Medical (Minneapolis) has received FDA 510(k) clearance for its GuardDOG Occlusion System for use during the treatment of peripheral vascular disease.

The GuardDOG is designed to enable physicians to “quickly and effectively manage local blood flow” when using interventional techniques and devices to treat vascular disease.

Jules Fisher, vice president, finance and CFO of Possis, described GuardDOG as the “first guidewire-based occlusion device” that's designed specifically for and marketed for the peripheral vasculature.

“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,” Fisher said.

The device itself features a 0.035” diameter guidewire, which is “preferred” for peripheral interventions, the company said. The device also has a CO2-filled balloon providing “quick inflation and deflation.”

Designed to facilitate delivery of over-the-wire interventional tools, the GuardDOG system can be delivered through 0.038” diagnostic catheters to the embolism treatment site.

“The GuardDOG can be inflated, deflated, and positioned up to three times during a single procedure, improving efficiencies in both routine and complicated procedures,” Possis said. “These GuardDOG System features enable physicians to manage blood flow and achieve desired occlusion in peripheral vessels 3 mm to 6 mm in size.”

Fisher told Medical Device Daily that Possis expects the GuardDOG device to be an “adjunctive” device to its AngioJet Thrombectomy system, which the company calls “the most advanced catheter-based thrombectomy system available today.”

Possis also has catheters that are designed for peripheral catheter thrombectomy. “This is a great fit, because the biggest market opportunity that we see is just using it as an adjunctive device with AngioJet,” he said.

By using the GuardDOG device, doctors “are not competing with blood flow,” Fisher said. “It reduces hemolysis,” he said.

By combining the occlusion device with the Possis Power Pulse delivery system, which is designed to deliver clot-busting drugs directly to the thrombus, it works well together because it prevent the blood flow from moving the drugs away from the thrombus site.

Fisher said any discussion of occlusion devices suggests names of other companies' occlusion devices, such as Medtronic 's (Minneapolis) PercuSurge balloon occlusion device, but the GuardDOG is “not that type of device.” Another occlusion device is the Spider distal occlusion system by ev3 (Plymouth, Minnesota).

However, Fisher said that those are 0.014” wire systems, whereas GuardDOG is 0.035”, and “it's specifically designed for treating peripheral vascular disease.”

The company's approximately 80-person direct sales force will remain the same, Fisher said, since the occlusion device “fits really well with our current” sales effort.

Possis said it is currently completing necessary production “requirements” in advance of market evaluations planned at “select medical sites” in order to support a full U.S. market release “by the end of the calendar year.”

The company said that anticipated revenue from the GuardDOG System is reflected in the company's current guidance for fiscal 2007. Regarding market opportunity, Fisher estimated that from 70,000 to 80,000 procedures are performed each year in the U.S. using the company's medium-length catheters, or those designed for peripheral vascular uses. That would put the total market opportunity for GuardDOG at about $70 million to $80 million.

In addition to the 0.035” GuardDOG device, Possis also is developing a 0.014” version of the device, for which it expects to secure FDA 510(k) clearance later in FY07.

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