Kensey Nash seeks FDA OK to market ThromCat blood clot remover

By Angela McDaniels

Seattle, Jan. 5 - Kensey Nash Corp. said it has submitted a premarket notification to the Food and Drug Administration requesting permission to market its ThromCat thrombectomy catheter system.

The ThromCat system is a thrombectomy catheter designed to remove thrombus or blood clots from a patient. It is indicated for use in AV grafts and fistulas, and the company said it plans to study the utility of the device for application in additional vessels in the coming year.

The ThromCat device is disposable and uses an internal rotating helix that creates a vacuum to draw the blood clot into the catheter and macerate it, while simultaneously flushing to aid in its removal.

"We are confident that the ThromCat System will have significant ease of use advantages over other mechanical thrombectomy alternatives in the marketplace," president and chief executive officer Joseph W. Kaufmann said in a company news release.

"We have received very positive feedback from physician advisors who believe this type of device will be useful in their practices and meets a need that is not currently being fulfilled by other devices."

The ThromCat System will be sold through Kensey Nash's direct U.S. endovascular sales force. The company estimated the current market for thrombectomy catheter systems to be $100 million worldwide.

Kensey Nash is based in Exton, Pa., and develops and manufactures absorbable, biomaterial-based products with applications in the cardiology, orthopaedics, spine, drug and biologics delivery, dental, surgical and wound care markets.

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