Spectranetics Corporation has received the CE mark approval for its next-generation ThromCat XT Thrombus Removal System. The ThromCat XT is a single-use, disposable device designed for mechanical removal of thrombus from native coronary arteries and infra-inguinal arteries. The company will commence the launch of the product immediately in Europe. The CE mark approval triggers a milestone payment of $1.5 million pursuant to the company’s Amended Development and Regulatory Services agreement with Kensey Nash Corporation.
The ThromCat XT System features an enhanced thrombus removal and several advancements in ease-of-use compared to the current ThromCat System. The consistent vacuum pressure generated by ThromCat XT System at the tip of the catheter helps in drawing thrombus into the extraction ports where it is then macerated by an internal helix. The thrombus is then transported to an external collection bag without any contact with the blood stream. The ThromCat XT is offered in 150cm length to treat vessels 2.5 – 7 mm in diameter. It is completely disposable.
ThromCat XT System was first used in a procedure performed on a 70-year-old female patient with heart failure and a totally occluded Right Coronary Artery by Dr. Danny Nguyen in consultation with Prof. Dr. med Michael Haude of the Department of Cardiology, Städtische Kliniken Neuss- Lukaskrankenhaus in Neuss, Germany.
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 US,” said Emile J. Geisenheimer, Chairman, President and Chief Executive Officer.