Spectranetics Receives CE Mark Approval For ThromCat(R)XT

Main Category: Blood / Hematology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 25 Jun 2009 - 4:00 PDT

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Spectranetics Corporation (Nasdaq:SPNC) reported that it has received the CE mark approval for its next-generation ThromCat® XT Thrombus Removal System, a single-use, disposable device indicated for mechanical removal of thrombus from native coronary arteries and infra-inguinal arteries. The launch of the product will commence immediately within the European Union. The approval triggers a milestone payment of $1.5 million pursuant to the Company's Amended Development and Regulatory Services agreement with Kensey Nash Corporation (Nasdaq:KNSY).

The ThromCat XT System is an improvement to the current ThromCat System with enhanced thrombus removal and several advancements in ease-of-use. The ThromCat XT System generates a consistent vacuum pressure at the tip of the catheter to draw thrombus into the extraction ports where it is then macerated by an internal helix. Without further contact with the blood stream, the thrombus is then transported to an external collection bag. The ThromCat XT is completely disposable and offered in 150cm length to treat vessels 2.5 - 7 mm in diameter.

The first use of the ThromCat XT System occurred in a procedure performed by Dr. Danny Nguyen in consultation with Prof. dr. med Michael Haude of the Department of Cardiology, Städtische Kliniken Neuss- Lukaskrankenhaus in Neuss, Germany. The intervention was performed on a 70-year-old female patient with heart failure and a totally occluded Right Coronary Artery (RCA). Thrombectomy was successfully completed with the ThromCat XT, and was followed by direct stenting of the proximal and middle sections of the RCA, restoring normal flow.

Prof. Haude and Dr. Nguyen commented after the procedure, "We are very satisfied with the overall performance of the ThromCat XT. In contrast to the previous version of the ThromCat, the set up time was significantly shortened, and the device was easy to use. In addition, this new version of the ThromCat provides better pushability and trackability within the vessel. The device was able to remove virtually all thrombus from a 100% occluded vessel that contained significant thrombus burden. We are very happy with the result for the patient after doing the first ThromCat XT case."

"European thrombectomy revenue currently represents nearly half of Spectranetics' worldwide thrombectomy sales and is a key growth driver of international revenue. I am pleased that we will be able to launch the newly designed ThromCat XT System in this important market and are currently in discussions with the Food and Drug Administration to identify the regulatory pathway for the ThromCat XT system in the United States," said Emile J. Geisenheimer, Chairman, President and Chief Executive Officer.

Source
Spectranetics

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