WIRE)–Covidien, a leading global provider of healthcare
products, today announced that the U.S. Food and Drug Administration (FDA) has
cleared SpiderFX® for the treatment of severely calcified lesions
used in conjunction with plaque excision in arteries of the lower extremities.
It is the only embolic protection device indicated for this treatment in the United States.
Embolic protection devices are used to capture and remove
debris that becomes dislodged during an interventional procedure. Embolic debris
may block smaller vessels, resulting in procedural complications or poor
patient outcomes. While the risk of complications associated with embolic
debris exists during all types of interventional procedures, patients with
complex conditions such as critical limb ischemia, single vessel runoff or
complex lesions (such as calcium or thrombus) face even greater risk.
Covidien submitted the 510(k) to the FDA seeking clearance
for use of the SpiderFX embolic protection device in lower extremity endovascular
procedures, based on results from the DEFINITIVE™ Ca++ clinical study.
DEFINITIVE Ca++ enrolled 133 subjects from 17 investigational clinical sites.
It demonstrated that plaque excision with Covidiens TurboHawk™ device
utilizing distal embolic protection with the SpiderFX can be used safely and
effectively in patients who have severely calcified superficial femoral artery
and popliteal artery lesions, including those with single vessel runoff.
“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,” said Daniel Clair, M.D., Chairman
of the Department of Vascular Surgery at the Cleveland Clinic and Professor of
Surgery, Cleveland Clinic Lerner College of Medicine. Dr. Clair does research
consulting work with Covidien.
SpiderFX has the broadest indication among distal embolic
filters in the U.S.
with indications for carotid, coronary saphenous vein graft, and lower
extremity use. SpiderFX is already indicated for use in the lower extremities
in most geographies outside of the U.S.
and has been sold in Europe since 2005.
Following this FDA clearance, SpiderFX is now available for use in the lower
extremities in the U.S.
“Certain high-risk situations necessitate use of an embolic
protection device because an embolic event is more likely to occur,” said Mark
A. Turco, MD, Chief Medical Officer, Vascular Therapies, Covidien. “Our goal is
to educate physicians about the importance of using an embolic protection
device during high-risk situations, such as severely calcified lesions.”
Covidien is a leading global healthcare products company that creates
innovative medical solutions for better patient outcomes and delivers value
through clinical leadership and excellence. Covidien manufactures, distributes
and services a diverse range of industry-leading product lines in three
segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2011
revenue of $11.6 billion, Covidien has 41,000 employees worldwide in more than
65 countries, and its products are sold in over 140 countries. Please visit www.covidien.com to learn more about our business.
Posted by Sean Fenske, Editor-in-Chief, MDT