Spectranetics Corporation (Nasdaq:SPNC) today 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.
