Gunther Tulip Vena Cava Filter From Cook Incorporated Receives FDA Clearance For Retrievability.
BLOOMINGTON, Ind.--(BUSINESS WIRE)--Nov. 10, 2003
The U.S. Food and Drug Administration granted clearance on October 31 for the Gunther Tulip(TM) Vena Cava Filter from Cook Incorporated to treat U.S. patients who may need temporary protection from pulmonary embolism (PE). The Gunther Tulip is an implanted device used to capture blood clots caused by trauma, surgery or other medical conditions before they can reach the lungs, causing a pulmonary embolism. Each year in the U.S., an estimated 600,000 people experience a pulmonary embolism, causing up to 200,000 deaths. Released for use in the U.S. in October 2000, the Gunther Tulip may now be retrieved if the patient's risk of pulmonary embolism has diminished.
"While permanent implantation of a vena cava filter may be beneficial in some cases, younger patients and those with temporary needs for embolic protection will benefit significantly from having a filter placed only when their need is greatest," explained Kem Hawkins, president and CEO of Cook Incorporated. "Since 1992, patients in Europe and elsewhere have enjoyed this benefit with Cook's Gunther Tulip Vena Cava Filter, and now we are very pleased to add this retrieval indication for U.S. physicians, as well."
A key benefit of the Gunther Tulip is its ability to be used as either a temporary or permanent filter. "Why would you use a permanent filter when you can use an optional filter," noted John Kaufman, M.D., Chief of Vascular and Interventional Radiology at Oregon Health Sciences University. "By putting in an optional filter, referring physicians feel like they have more control over the management of thromboembolic disease..." However, for patients needing longer-term embolic protection, the device may be left in place indefinitely.
The Gunther Tulip Vena Cava Filter was developed jointly by William Cook Europe and Rolf Gunther, M.D., and was designed as both a temporary and permanent filter. The Gunther Tulip is a cone-shaped wire device with a hook on top that facilitates retrieval. The filter wires form the shape of tulip petals, thereby giving the device its name. The Gunther Tulip has been used as a retrievable filter in thousands of patients in Europe since 1992, and in Canada since 1998.
With international headquarters in Bloomington, Ind., privately held COOK(R) (www.cookgroup.com/) is a leading designer, manufacturer and global distributor of minimally invasive medical device technology for diagnostic and therapeutic procedures. Since its founding in 1963, Cook has created innovative technologies for stents and stent-grafts, catheters, wire guides, introducer needles and sheaths, embolization coils, medical biomaterials, vena cava filters, and other minimally invasive medical devices.
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|Date:||Nov 10, 2003|
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