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Gunther Tulip Vena Cava Filter From Cook Incorporated Receives FDA Clearance For Retrievability.



Business Editors/Health/Medical Writers

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 Vena Cava Filter Definition

A vena cava filter is a device inserted into a major vein to prevent a blood clot from entering the lungs.
Purpose
 from Cook Incorporated to treat U.S. patients who may need temporary protection from pulmonary embolism Pulmonary Embolism Definition

Pulmonary embolism is an obstruction of a blood vessel in the lungs, usually due to a blood clot, which blocks a coronary artery.
 (PE). The Gunther Tulip is an implanted device used to capture blood clots Blood Clots Definition

A blood clot is a thickened mass in the blood formed by tiny substances called platelets. Clots form to stop bleeding, such as at the site of cut.
 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 embolic /em·bol·ic/ (em-bol´ik) pertaining to an embolus or to embolism.

em·bol·ic
adj.
1. Relating to, or caused by an embolus or embolism.

2. Relating to emboly.
 protection will benefit significantly from having a filter placed only when their need is greatest," explained Kem Hawkins, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  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 interventional radiology Imaging A subspecialty of radiology that provides Diagnostic information–eg, CT-guided 'skinny' needle biopsies and dye injection for analysis of various lumina and tracts–eg, arteriography, cholangiography, antegrade  at Oregon Health Sciences University. "By putting in an optional filter, referring physicians feel like they have more control over the management of thromboembolic thromboembolic

pertaining to or emanating from thromboembolism.


thromboembolic meningoencephalitis
see hemophilosis.

thromboembolic parasitism
see thromboembolic colic.
 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 embolization /em·bo·li·za·tion/ (em?bo-li-za´shun)
1. the process or condition of becoming an embolus.

2. therapeutic introduction of a substance into a vessel in order to occlude it.
 coils, medical biomaterials, vena cava filters, and other minimally invasive medical devices.
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Publication:Business Wire
Geographic Code:1USA
Date:Nov 10, 2003
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