Kensey Nash gets 510(k) clearance for disposable ThromCat catheter

By Elaine Rigoli

Tampa, Fla., April 27 - Kensey Nash Corp. has received 510(k) clearance from the Food and Drug Administration for its ThromCat thrombectomy catheter system designed to remove thrombus or blood clots from a patient, with an initial indication for use in AV grafts and fistulas.

According to industry sources, the current market for thrombectomy catheter systems approximates $100 million worldwide, including the coronary market, and the company said the worldwide market could expand with the offering of a simple device.

"We envision it as a device that will be useful for interventional cardiologists, interventional radiologists and also vascular surgeons to quickly and easily remove moderate to relatively heavy thrombus burdens. We believe it will be an important product within our endovascular portfolio and that it is a perfect complement to our recently launched QuickCat extraction catheter," president and chief executive officer Joseph W. Kaufmann said in a news release.

The ThromCat system, expected to be launched within the next 90 days, will be sold through Kensey Nash's direct U.S. endovascular sales force.

CE Mark approval, to allow the sale of the ThromCat system in the European Union, is also currently pending.

The company said it plans to study the utility of the device for application in additional vessels in the coming year.

Kensey Nash is a medical technology company located in Exton, Pa.

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