Healthcare Industry News:  Kensey Nash 

Devices Interventional Regulatory

 News Release - June 23, 2009

Spectranetics Receives CE Mark Approval for ThromCat(R)XT

COLORADO SPRINGS, Colo.--(HSMN NewsFeed)--Spectranetics Corporation (Nasdaq:SPNC ) today reported that it has received the CE mark approval for its next-generation ThromCat(R) 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.

About Spectranetics

Spectranetics manufactures and markets the only Excimer Laser System approved in the United States, Canada, Europe and Japan for use in minimally invasive interventional procedures within the cardiovascular system. More than 800 Spectranetics laser systems are used in hospitals worldwide.

The Company’s Vascular Intervention (VI) products include a range of peripheral and cardiac laser catheters for ablation of occluded arteries above and below the knee and within coronary arteries. The Company also markets aspiration catheters for the removal of thrombus and support catheters to facilitate crossing of coronary and peripheral arterial blockages.

The Lead Management (LM) product line includes excimer laser sheaths and cardiac lead management accessories for the removal of pacemaker and defibrillator cardiac leads.

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Safe Harbor Statement

This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties may include adverse results of the FDA and Immigration and Customs Enforcement investigation, adverse results of the securities litigation or the stockholder derivative litigation in which the Company or any of its officers or directors is a party, insufficient insurance coverage or the denial of insurance coverage related to legal costs or any settlement or judgment in connection with those proceedings, continued or worsening adverse conditions in the general domestic and global economic markets and continued volatility and disruption of the credit markets, which, among other things, affects the ability of hospitals and other health care systems to obtain credit and may impede our access to capital and has rendered our investments in auction rate securities illiquid, market acceptance of excimer laser atherectomy technology, increasing price and product competition, increased pressure on expense levels resulting from expanded sales, marketing, product development and clinical activities, uncertain success of the Company's strategic direction, dependence on new product development, intellectual property claims of third parties, availability of inventory from suppliers, adverse outcome of FDA inspections, the receipt of FDA approval to market new products or applications and the timeliness of any approvals, market acceptance of new products or applications, product defects, ability to manufacture sufficient volumes to fulfill customer demand, availability of vendor-sourced components at reasonable prices, unexpected delays or costs associated with the Company’s relocation and consolidation of its headquarters and manufacturing operations, and price volatility due to the initiation or cessation of coverage, or changes in ratings, by securities analysts. For a further list and description of such risks and uncertainties that could cause the actual results, performance or achievements of the Company to be materially different from any anticipated results, performance or achievements, please see the Company's previously filed SEC reports. Spectranetics disclaims any intention or obligation to update or revise any financial projections or forward-looking statements, whether as a result of new information, future events or otherwise.

In assessing the Company’s financial outlook, Spectranetics’ management considered many factors and assumptions including, but not limited to, current and projected sales trend data; status, timing and progression of the Company’s product development projects; current and projected spending levels to support sales, marketing, development and administrative activities; anticipated timing and costs associated with the relocation and consolidation of its headquarters and manufacturing operation, and other risk factors discussed in Spectranetics’ publicly filed documents.

Source: Spectranetics

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