Covidien’s SpiderFX wins FDA clearance | Regulatory Roundup

December 1, 2011 By MassDevice staff

SpiderFX embolic protection device

Covidien (NYSE:COV) landed 510(k) clearance for its SpiderFX system to treat severely calcified lesions in the lower extremities.

The Mansfield, Mass.-based med-tech titan’s system has been on the European market since 2005 and is currently the only embolic protection device indicated for use in the lower extremities in the U.S.

Covidien sought 510(k) approval from the federal watchdog agency based on results of its 133 subject Definitive Ca++ clinical study, which showed that the SpiderFX system could be used in conjunction with plaque excision to treat severely calcified lesions in arteries of the lower extremities,

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The SpiderFX system was tested with Covidien’s TurboHawk plaque excision device, which won FDA approval in January.

"The expanded indication of these devices offers interventionalists a safer option for dealing with severely calcified lesions. In complex cases, this technology shows promise of being a positive step forward for treating patients with peripheral arterial disease," Daniel Clair, professor of surgery at Cleveland Clinic Lerner College of Medicine said in prepared remarks.

The news from the FDA hasn’t done much for COV on Wall Street, where shares are only up 2 percent at $46.40 in mid-morning trading versus $45.55 at market close yesterday.

Late last month, Covidien acquired med-tech maker Barrx Medical for $325 million.

Sunnyvale, Calif.-based Barrx specializes in minimally invasive radiofrequency ablation systems that target precancerous tissue in the esophagus.

Covidien will acquire all outstanding Barrx stock in a deal slated to close by January 31, 2012.

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