Key Developments For Spectranetics Corp
Spectranetics Corp (SPNC.O) (Consolidated Issue listed on NASDAQ Global Market)
The Spectranetics Corporation Reaffirms FY 2009 Earnings Guidance
The Spectranetics Corporation announced that it expects to incur a pre-tax loss for fiscal 2009. According to Reuters Estimates, analysts were expecting the Company to report pre-tax profit of $(6.27) million for fiscal 2009.
The Spectranetics Corporation Submits 510(k) Application To Food and Drug Administration Seeking Clearance For Treatment Of In-Stent Restenosis In Legs
The Spectranetics Corporation announced that it has filed a 510(k) application with the Food and Drug Administration seeking clearance for the treatment of in-stent restenosis (ISR) in the legs with its commercially available peripheral atherectomy products. ISR is caused by the re-growth of tissue within the stent, known as neointimal hyperplasia, which can lead to blockages in the affected leg artery. The 510(k) application makes reference to the results of bench testing associated with the interaction of laser and nitinol stents. This testing shows that stents subjected to extensive fatigue testing following laser interaction had no fatigue-related failures. The submission also includes reference to clinical data supporting the safety and efficacy of excimer laser treatment in coronary artery ISR and an analysis of interim data from the peripheral artery ISR study, PATENT, which is ongoing in Germany. Although the data from the PATENT trial is preliminary, no evidence of stent damage has been observed during the procedure or during subsequent follow-up evaluations.
The Spectranetics Corporation Comments On H2, FY 2009 Earnings Guidance
The Spectranetics Corporation announced that it expects to incur a pre-tax loss for fiscal 2009 the pre-tax loss in the second half of 2009 is anticipated to be less than pre-tax loss incurred during the first half of 2009.
The Spectranetics Corporation Announces FDA Clearance To Market Turbo-Tandem System
The Spectranetics Corporation reported that it has received clearance from the Food and Drug Administration (FDA) to market the Turbo-Tandem, a single-use, disposable device indicated for atherectomy of infrainguinal arteries. CE mark approval is also in place for marketing within the European Union and was received earlier this month.
The Spectranetics Corporation Receives CE Mark Approval For ThromCatXT
The Spectranetics Corporation reported that it has received the CE mark approval for its 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 payment of $1.5 million pursuant to the Company`s Amended Development and Regulatory Services agreement with Kensey Nash Corporation.
