Tuesday, single use medical device manufacturer Spectranetics Corp. (SPNC), said it was granted CE mark approval by the European Union for its next-generation ThromCat XT Thrombus Removal System , indicated for mechanical removal of thrombus from native coronary arteries and infra-inguinal arteries.
The Colorado Springs, Colorado-based company said it would make a milestone payment of $1.5 million pursuant to its amended development and regulatory services agreement with Exton, Pennsylvania-based medical technology company Kensey Nash Corp. (KNSY), following the approval.
The ThromCat XT System is indicated as an improved version to the current ThromCat System with enhanced thrombus removal and several advancements in ease-of-use, and 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.
Spectranetics said that it is currently in discussions with the Food and Drug Administration to identify the regulatory pathway for the ThromCat XT system in the United States.
The company noted that ThromCat XT is completely disposable and offered in 150cm length to treat vessels 2.5 mm - 7 mm in diameter. The launch of the single-use, disposable device will start immediately within the European Union.
SPNC closed Monday's trading at $4.84 on the Nasdaq.
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