Spectranetics Corp. (SPNC), a manufacturer of single-use medical devices, said on Monday that it has temporarily suspended enrollment in the VIVA II: Salvage trial, after being contacted by the Food and Drug Administration, or FDA, about a potential safety concern relating to the laser device.
The Salvage trial is designed to evaluate the safety and performance of Spectranetics' laser and certain other products for the treatment of in-stent restenosis, or ISR, within nitinol stents implanted in the superficial femoral artery, or SFA.
The company said that it has enrolled 25 of the planned 100 patients with ISR in the SFA, till date. Spectranetics believes the potential concern relates to laser interaction with nitinol stents.
Chief executive officer of Spectranetics, John Schulte commented, "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."
Shares of Spectranetics closed Tuesday's regular trade at $4.26, down 39 cents or 8.39%. In the extended hours trading, the stock further declined 26 cents or 6.10%.
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