Healthcare Industry News: nitinol stent
News Release - September 15, 2008
Spectranetics Provides Update on VIVA II: SALVAGE Trial
COLORADO SPRINGS, Colo.--(HSMN NewsFeed)--Spectranetics (NASDAQ: SPNC ) today provided an update on the VIVA II: SALVAGE trial.To date, 25 of the planned 100 patients with ISR in the SFA have been enrolled. VIVA has elected to temporarily suspend enrollment in the study after being contacted by the Food and Drug Administration (FDA) about a potential safety concern relating to the laser device. Spectranetics believes the potential concern relates to laser interaction with nitinol stents.
On September 11, 2008, Spectranetics submitted to the FDA a report entitled “Nitinol Ablation / Fatigue Testing Results” that indicates stents subjected to extensive fatigue testing following laser interaction had no fatigue-related failures. The testing that was the basis of this report began in December 2007 following development of a testing protocol reviewed by and agreed upon with FDA. The FDA did not have this report at the time they contacted VIVA regarding their potential concern.
“We respect the decision by VIVA to take a conservative approach with this study and look forward to the results of the FDA’s review of the safety data we just submitted related to laser interaction with nitinol stents. To be clear, this decision by VIVA does not reflect or speak to our products when used for labeled or cleared indications,” said John G. Schulte, President and Chief Executive Officer of Spectranetics. “We are continuing to work closely with the FDA to provide all the information necessary so that the physician investigators can resume enrollment in the SALVAGE study.”
About Spectranetics
Founded in 1984, Spectranetics manufactures and sells the only excimer laser approved in the United States, Europe and Japan for use in minimally invasive cardiovascular procedures. This technology treats complex cardiovascular conditions by photo-ablating multiple lesion types into tiny particles that are easily absorbed into the blood stream. The Company’s disposable catheters use high-energy “cool” ultraviolet light to vaporize arterial blockages in the legs and heart, as well as scar tissue encapsulating pacing and defibrillation leads. For more information visit www.spectranetics.com.
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 that could result in an adverse impact on the Company’s business, 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, 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.
Source: Spectranetics
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