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,
Sign up to get our free newsletters delivered straight to your inbox
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.
- FDA establishes new product codes
The FDA established new product codes for interbody devices with integrated Fixation. RBS Spine received a revised FDA clearance letter for its InterPlate system yesterday.
Read more - CardioInsight announces CE Mark of Ecvue
Cleveland, Ohio-based CardioInsight Technologies Inc. won CE Mark approval for its Ecvue system to help diagnose cardiac arrhythmias.
Read more - Riverain Technologies lands PMA for OnGuard update
Riverain Technologies landed PMA supplemental approval from the federal watchdog agency for a software update on its OnGuard computer-aided detection system.
Read more - Feeding tube cleared by FDA
Applied Medical Technology’s "Low-profile transgastric-Jejunal feeding tube kit" was listed on the FDA’s 510(k) clearance list for October.
Read more
